Elizabeth Mechcatie

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

These labeling changes are the result of the FDA’s review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

The results of these studies were the focus of a meeting of the FDA’s Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

These labeling changes are the result of the FDA’s review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

The results of these studies were the focus of a meeting of the FDA’s Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

These labeling changes are the result of the FDA’s review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

The results of these studies were the focus of a meeting of the FDA’s Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

The record high level of influenza vaccination achieved during the 2009-2010 influenza season was sustained during the latest influenza season, but "opportunity exists to improve coverage in all age groups, particularly among adults," according to a report from the Centers for Disease Control and Prevention.

As of the end of February, almost 43% of people aged 6 months and older in 43 states and the District of Columbia had received the influenza vaccine during the 2010-2011 influenza season, compared with about 41% of people in this age group during the 2009-2010 season. The report – which estimated vaccine coverage for the 2010-2011 season based on influenza vaccine coverage rates in 43 states and D.C. using national surveillance data – appeared in the June 10 issue of Morbidity and Mortality Weekly Report (MMWR Morb. Mortal. Wkly. Rep. 2011;60: 737-43).

Photo credit: © BVDC / Fotolia.com

The 2010-2011 season is the first season that the CDC’s Advisory Committee on Immunization Practices recommended influenza vaccination for all people aged 6 months and older. This season also followed the season that was marked by the influenza A pandemic (H1N1).

The report estimates that from August 2010 through February 2011, almost half (49%) of children and adolescents aged 6 months through 17 years had been vaccinated, compared with 42% during the previous season.

Among adults, coverage was 30% among adults aged 18-49 years, similar to the previous season. For those aged 50-64 years, coverage was almost 46%, which was similar to the previous season (about 45%). Among those aged 65 years and older, almost 69% were vaccinated in this season and in the 2009-2010 season.

Overall, vaccine coverage during 2010-2011 was highest among non-Hispanic whites (44%), compared with 38.8% among non-Hispanic blacks and 40.6% among Hispanics. Among people of other races/ethnicity ("non-Hispanic others") coverage was almost 43%.

Among adults, coverage was also highest among non-Hispanic whites, at 43.3%, compared with 39% among the non-Hispanic others, 34.9% among non-Hispanic blacks, and 32.4% of Hispanics. Coverage increased by 3.6% compared with the previous year for the non-Hispanic blacks, but was similar among the other groups.

The proportion of children aged 6 months through 17 years who had been vaccinated was highest for Hispanics, at 55%, followed by 53.6% among non-Hispanic others, 47.9% among non-Hispanic blacks, and 46.3% among non-Hispanic whites. Compared with the 2009-2010 season, coverage increased by almost 4% among whites, and by 11%-12% among the non-Hispanic whites and non-Hispanic black children, but was about the same among non-Hispanic others.

Possible reasons behind the "moderate" increase in vaccination of children included ACIP’s recommendation to vaccinate all children aged 6-18 months, which was first recommended in the 2009-2010 season, according to an editorial note that accompanied the report. The elimination in racial and ethnic disparities among non-Hispanic black and Hispanic children during this season may be partly due to the Vaccines for Children program, the editorial said.

There was no significant increase in the vaccination coverage for people aged 19-49 years, despite the universal vaccination recommendation, "underscoring the challenges associated with increasing coverage in this group," the editorial note said. The report also estimated that for adults aged 18-64 years with high risk medical conditions, coverage was 48.4%.

Despite improvements in vaccination coverage, "further work remains to reduce racial/ethnic disparities among adults, and to bring annual seasonal vaccination coverage levels to Healthy People 2020 targets," the editorial concluded. Those targets are 80% for people aged 6 months to 64 years, and 90% for adults aged 18-64 years with high-risk conditions and adults aged 65 years and older.

The record high level of influenza vaccination achieved during the 2009-2010 influenza season was sustained during the latest influenza season, but "opportunity exists to improve coverage in all age groups, particularly among adults," according to a report from the Centers for Disease Control and Prevention.

As of the end of February, almost 43% of people aged 6 months and older in 43 states and the District of Columbia had received the influenza vaccine during the 2010-2011 influenza season, compared with about 41% of people in this age group during the 2009-2010 season. The report – which estimated vaccine coverage for the 2010-2011 season based on influenza vaccine coverage rates in 43 states and D.C. using national surveillance data – appeared in the June 10 issue of Morbidity and Mortality Weekly Report (MMWR Morb. Mortal. Wkly. Rep. 2011;60: 737-43).

Photo credit: © BVDC / Fotolia.com

The 2010-2011 season is the first season that the CDC’s Advisory Committee on Immunization Practices recommended influenza vaccination for all people aged 6 months and older. This season also followed the season that was marked by the influenza A pandemic (H1N1).

The report estimates that from August 2010 through February 2011, almost half (49%) of children and adolescents aged 6 months through 17 years had been vaccinated, compared with 42% during the previous season.

Among adults, coverage was 30% among adults aged 18-49 years, similar to the previous season. For those aged 50-64 years, coverage was almost 46%, which was similar to the previous season (about 45%). Among those aged 65 years and older, almost 69% were vaccinated in this season and in the 2009-2010 season.

Overall, vaccine coverage during 2010-2011 was highest among non-Hispanic whites (44%), compared with 38.8% among non-Hispanic blacks and 40.6% among Hispanics. Among people of other races/ethnicity ("non-Hispanic others") coverage was almost 43%.

Among adults, coverage was also highest among non-Hispanic whites, at 43.3%, compared with 39% among the non-Hispanic others, 34.9% among non-Hispanic blacks, and 32.4% of Hispanics. Coverage increased by 3.6% compared with the previous year for the non-Hispanic blacks, but was similar among the other groups.

The proportion of children aged 6 months through 17 years who had been vaccinated was highest for Hispanics, at 55%, followed by 53.6% among non-Hispanic others, 47.9% among non-Hispanic blacks, and 46.3% among non-Hispanic whites. Compared with the 2009-2010 season, coverage increased by almost 4% among whites, and by 11%-12% among the non-Hispanic whites and non-Hispanic black children, but was about the same among non-Hispanic others.

Possible reasons behind the "moderate" increase in vaccination of children included ACIP’s recommendation to vaccinate all children aged 6-18 months, which was first recommended in the 2009-2010 season, according to an editorial note that accompanied the report. The elimination in racial and ethnic disparities among non-Hispanic black and Hispanic children during this season may be partly due to the Vaccines for Children program, the editorial said.

There was no significant increase in the vaccination coverage for people aged 19-49 years, despite the universal vaccination recommendation, "underscoring the challenges associated with increasing coverage in this group," the editorial note said. The report also estimated that for adults aged 18-64 years with high risk medical conditions, coverage was 48.4%.

Despite improvements in vaccination coverage, "further work remains to reduce racial/ethnic disparities among adults, and to bring annual seasonal vaccination coverage levels to Healthy People 2020 targets," the editorial concluded. Those targets are 80% for people aged 6 months to 64 years, and 90% for adults aged 18-64 years with high-risk conditions and adults aged 65 years and older.

The record high level of influenza vaccination achieved during the 2009-2010 influenza season was sustained during the latest influenza season, but "opportunity exists to improve coverage in all age groups, particularly among adults," according to a report from the Centers for Disease Control and Prevention.

As of the end of February, almost 43% of people aged 6 months and older in 43 states and the District of Columbia had received the influenza vaccine during the 2010-2011 influenza season, compared with about 41% of people in this age group during the 2009-2010 season. The report – which estimated vaccine coverage for the 2010-2011 season based on influenza vaccine coverage rates in 43 states and D.C. using national surveillance data – appeared in the June 10 issue of Morbidity and Mortality Weekly Report (MMWR Morb. Mortal. Wkly. Rep. 2011;60: 737-43).

Photo credit: © BVDC / Fotolia.com

The 2010-2011 season is the first season that the CDC’s Advisory Committee on Immunization Practices recommended influenza vaccination for all people aged 6 months and older. This season also followed the season that was marked by the influenza A pandemic (H1N1).

The report estimates that from August 2010 through February 2011, almost half (49%) of children and adolescents aged 6 months through 17 years had been vaccinated, compared with 42% during the previous season.

Among adults, coverage was 30% among adults aged 18-49 years, similar to the previous season. For those aged 50-64 years, coverage was almost 46%, which was similar to the previous season (about 45%). Among those aged 65 years and older, almost 69% were vaccinated in this season and in the 2009-2010 season.

Overall, vaccine coverage during 2010-2011 was highest among non-Hispanic whites (44%), compared with 38.8% among non-Hispanic blacks and 40.6% among Hispanics. Among people of other races/ethnicity ("non-Hispanic others") coverage was almost 43%.

Among adults, coverage was also highest among non-Hispanic whites, at 43.3%, compared with 39% among the non-Hispanic others, 34.9% among non-Hispanic blacks, and 32.4% of Hispanics. Coverage increased by 3.6% compared with the previous year for the non-Hispanic blacks, but was similar among the other groups.

The proportion of children aged 6 months through 17 years who had been vaccinated was highest for Hispanics, at 55%, followed by 53.6% among non-Hispanic others, 47.9% among non-Hispanic blacks, and 46.3% among non-Hispanic whites. Compared with the 2009-2010 season, coverage increased by almost 4% among whites, and by 11%-12% among the non-Hispanic whites and non-Hispanic black children, but was about the same among non-Hispanic others.

Possible reasons behind the "moderate" increase in vaccination of children included ACIP’s recommendation to vaccinate all children aged 6-18 months, which was first recommended in the 2009-2010 season, according to an editorial note that accompanied the report. The elimination in racial and ethnic disparities among non-Hispanic black and Hispanic children during this season may be partly due to the Vaccines for Children program, the editorial said.

There was no significant increase in the vaccination coverage for people aged 19-49 years, despite the universal vaccination recommendation, "underscoring the challenges associated with increasing coverage in this group," the editorial note said. The report also estimated that for adults aged 18-64 years with high risk medical conditions, coverage was 48.4%.

Despite improvements in vaccination coverage, "further work remains to reduce racial/ethnic disparities among adults, and to bring annual seasonal vaccination coverage levels to Healthy People 2020 targets," the editorial concluded. Those targets are 80% for people aged 6 months to 64 years, and 90% for adults aged 18-64 years with high-risk conditions and adults aged 65 years and older.

The record high level of influenza vaccination achieved during the 2009-2010 influenza season was sustained during the latest influenza season, but "opportunity exists to improve coverage in all age groups, particularly among adults," according to a report from the Centers for Disease Control and Prevention.

As of the end of February, almost 43% of people aged 6 months and older in 43 states and the District of Columbia had received the influenza vaccine during the 2010-2011 influenza season, compared with about 41% of people in this age group during the 2009-2010 season. The report – which estimated vaccine coverage for the 2010-2011 season based on influenza vaccine coverage rates in 43 states and D.C. using national surveillance data – appeared in the June 10 issue of Morbidity and Mortality Weekly Report (MMWR Morb. Mortal. Wkly. Rep. 2011;60: 737-43).

Photo credit: © BVDC / Fotolia.com

The 2010-2011 season is the first season that the CDC’s Advisory Committee on Immunization Practices recommended influenza vaccination for all people aged 6 months and older. This season also followed the season that was marked by the influenza A pandemic (H1N1).

The report estimates that from August 2010 through February 2011, almost half (49%) of children and adolescents aged 6 months through 17 years had been vaccinated, compared with 42% during the previous season.

Among adults, coverage was 30% among adults aged 18-49 years, similar to the previous season. For those aged 50-64 years, coverage was almost 46%, which was similar to the previous season (about 45%). Among those aged 65 years and older, almost 69% were vaccinated in this season and in the 2009-2010 season.

Overall, vaccine coverage during 2010-2011 was highest among non-Hispanic whites (44%), compared with 38.8% among non-Hispanic blacks and 40.6% among Hispanics. Among people of other races/ethnicity ("non-Hispanic others") coverage was almost 43%.

Among adults, coverage was also highest among non-Hispanic whites, at 43.3%, compared with 39% among the non-Hispanic others, 34.9% among non-Hispanic blacks, and 32.4% of Hispanics. Coverage increased by 3.6% compared with the previous year for the non-Hispanic blacks, but was similar among the other groups.

The proportion of children aged 6 months through 17 years who had been vaccinated was highest for Hispanics, at 55%, followed by 53.6% among non-Hispanic others, 47.9% among non-Hispanic blacks, and 46.3% among non-Hispanic whites. Compared with the 2009-2010 season, coverage increased by almost 4% among whites, and by 11%-12% among the non-Hispanic whites and non-Hispanic black children, but was about the same among non-Hispanic others.

Possible reasons behind the "moderate" increase in vaccination of children included ACIP’s recommendation to vaccinate all children aged 6-18 months, which was first recommended in the 2009-2010 season, according to an editorial note that accompanied the report. The elimination in racial and ethnic disparities among non-Hispanic black and Hispanic children during this season may be partly due to the Vaccines for Children program, the editorial said.

There was no significant increase in the vaccination coverage for people aged 19-49 years, despite the universal vaccination recommendation, "underscoring the challenges associated with increasing coverage in this group," the editorial note said. The report also estimated that for adults aged 18-64 years with high risk medical conditions, coverage was 48.4%.

Despite improvements in vaccination coverage, "further work remains to reduce racial/ethnic disparities among adults, and to bring annual seasonal vaccination coverage levels to Healthy People 2020 targets," the editorial concluded. Those targets are 80% for people aged 6 months to 64 years, and 90% for adults aged 18-64 years with high-risk conditions and adults aged 65 years and older.

The record high level of influenza vaccination achieved during the 2009-2010 influenza season was sustained during the latest influenza season, but "opportunity exists to improve coverage in all age groups, particularly among adults," according to a report from the Centers for Disease Control and Prevention.

As of the end of February, almost 43% of people aged 6 months and older in 43 states and the District of Columbia had received the influenza vaccine during the 2010-2011 influenza season, compared with about 41% of people in this age group during the 2009-2010 season. The report – which estimated vaccine coverage for the 2010-2011 season based on influenza vaccine coverage rates in 43 states and D.C. using national surveillance data – appeared in the June 10 issue of Morbidity and Mortality Weekly Report (MMWR Morb. Mortal. Wkly. Rep. 2011;60: 737-43).

Photo credit: © BVDC / Fotolia.com

The 2010-2011 season is the first season that the CDC’s Advisory Committee on Immunization Practices recommended influenza vaccination for all people aged 6 months and older. This season also followed the season that was marked by the influenza A pandemic (H1N1).

The report estimates that from August 2010 through February 2011, almost half (49%) of children and adolescents aged 6 months through 17 years had been vaccinated, compared with 42% during the previous season.

Among adults, coverage was 30% among adults aged 18-49 years, similar to the previous season. For those aged 50-64 years, coverage was almost 46%, which was similar to the previous season (about 45%). Among those aged 65 years and older, almost 69% were vaccinated in this season and in the 2009-2010 season.

Overall, vaccine coverage during 2010-2011 was highest among non-Hispanic whites (44%), compared with 38.8% among non-Hispanic blacks and 40.6% among Hispanics. Among people of other races/ethnicity ("non-Hispanic others") coverage was almost 43%.

Among adults, coverage was also highest among non-Hispanic whites, at 43.3%, compared with 39% among the non-Hispanic others, 34.9% among non-Hispanic blacks, and 32.4% of Hispanics. Coverage increased by 3.6% compared with the previous year for the non-Hispanic blacks, but was similar among the other groups.

The proportion of children aged 6 months through 17 years who had been vaccinated was highest for Hispanics, at 55%, followed by 53.6% among non-Hispanic others, 47.9% among non-Hispanic blacks, and 46.3% among non-Hispanic whites. Compared with the 2009-2010 season, coverage increased by almost 4% among whites, and by 11%-12% among the non-Hispanic whites and non-Hispanic black children, but was about the same among non-Hispanic others.

Possible reasons behind the "moderate" increase in vaccination of children included ACIP’s recommendation to vaccinate all children aged 6-18 months, which was first recommended in the 2009-2010 season, according to an editorial note that accompanied the report. The elimination in racial and ethnic disparities among non-Hispanic black and Hispanic children during this season may be partly due to the Vaccines for Children program, the editorial said.

There was no significant increase in the vaccination coverage for people aged 19-49 years, despite the universal vaccination recommendation, "underscoring the challenges associated with increasing coverage in this group," the editorial note said. The report also estimated that for adults aged 18-64 years with high risk medical conditions, coverage was 48.4%.

Despite improvements in vaccination coverage, "further work remains to reduce racial/ethnic disparities among adults, and to bring annual seasonal vaccination coverage levels to Healthy People 2020 targets," the editorial concluded. Those targets are 80% for people aged 6 months to 64 years, and 90% for adults aged 18-64 years with high-risk conditions and adults aged 65 years and older.

The record high level of influenza vaccination achieved during the 2009-2010 influenza season was sustained during the latest influenza season, but "opportunity exists to improve coverage in all age groups, particularly among adults," according to a report from the Centers for Disease Control and Prevention.

As of the end of February, almost 43% of people aged 6 months and older in 43 states and the District of Columbia had received the influenza vaccine during the 2010-2011 influenza season, compared with about 41% of people in this age group during the 2009-2010 season. The report – which estimated vaccine coverage for the 2010-2011 season based on influenza vaccine coverage rates in 43 states and D.C. using national surveillance data – appeared in the June 10 issue of Morbidity and Mortality Weekly Report (MMWR Morb. Mortal. Wkly. Rep. 2011;60: 737-43).

Photo credit: © BVDC / Fotolia.com

The 2010-2011 season is the first season that the CDC’s Advisory Committee on Immunization Practices recommended influenza vaccination for all people aged 6 months and older. This season also followed the season that was marked by the influenza A pandemic (H1N1).

The report estimates that from August 2010 through February 2011, almost half (49%) of children and adolescents aged 6 months through 17 years had been vaccinated, compared with 42% during the previous season.

Among adults, coverage was 30% among adults aged 18-49 years, similar to the previous season. For those aged 50-64 years, coverage was almost 46%, which was similar to the previous season (about 45%). Among those aged 65 years and older, almost 69% were vaccinated in this season and in the 2009-2010 season.

Overall, vaccine coverage during 2010-2011 was highest among non-Hispanic whites (44%), compared with 38.8% among non-Hispanic blacks and 40.6% among Hispanics. Among people of other races/ethnicity ("non-Hispanic others") coverage was almost 43%.

Among adults, coverage was also highest among non-Hispanic whites, at 43.3%, compared with 39% among the non-Hispanic others, 34.9% among non-Hispanic blacks, and 32.4% of Hispanics. Coverage increased by 3.6% compared with the previous year for the non-Hispanic blacks, but was similar among the other groups.

The proportion of children aged 6 months through 17 years who had been vaccinated was highest for Hispanics, at 55%, followed by 53.6% among non-Hispanic others, 47.9% among non-Hispanic blacks, and 46.3% among non-Hispanic whites. Compared with the 2009-2010 season, coverage increased by almost 4% among whites, and by 11%-12% among the non-Hispanic whites and non-Hispanic black children, but was about the same among non-Hispanic others.

Possible reasons behind the "moderate" increase in vaccination of children included ACIP’s recommendation to vaccinate all children aged 6-18 months, which was first recommended in the 2009-2010 season, according to an editorial note that accompanied the report. The elimination in racial and ethnic disparities among non-Hispanic black and Hispanic children during this season may be partly due to the Vaccines for Children program, the editorial said.

There was no significant increase in the vaccination coverage for people aged 19-49 years, despite the universal vaccination recommendation, "underscoring the challenges associated with increasing coverage in this group," the editorial note said. The report also estimated that for adults aged 18-64 years with high risk medical conditions, coverage was 48.4%.

Despite improvements in vaccination coverage, "further work remains to reduce racial/ethnic disparities among adults, and to bring annual seasonal vaccination coverage levels to Healthy People 2020 targets," the editorial concluded. Those targets are 80% for people aged 6 months to 64 years, and 90% for adults aged 18-64 years with high-risk conditions and adults aged 65 years and older.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

These labeling changes are the result of the FDA's review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The results of these studies were the focus of a meeting of the FDA's Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

These labeling changes are the result of the FDA's review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The results of these studies were the focus of a meeting of the FDA's Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

These labeling changes are the result of the FDA's review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The results of these studies were the focus of a meeting of the FDA's Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

A recommendation against prescribing the highest available dose of simvastatin is among the changes in the labeling information for the drug, the Food and Drug Administration announced on June 8.

The 80-mg dose of simvastatin has been associated with an elevated risk of myopathy, particularly during the first 12 months of treatment, so the FDA is now recommending that this dose be used only for patients who have been taking this dose for 12 months or longer and have not had any signs of myopathy, according to a statement issued by the agency.

The increased risk of myopathy with this dose is also often related to interactions with some medications and a genetic predisposition towards simvastatin-related myopathy, the statement said.

The FDA is also advising health care professionals not to start new patients on this dose and to prescribe alternative LDL cholesterol–lowering drugs for patients who do not meet their LDL-cholesterol goal on the 40-mg dose of simvastatin.The 80-mg dose lowers LDL cholesterol by an additional 6% over the 40-mg dose, the statement said.

The 80-mg dose is the highest dose approved for simvastatin, which is marketed as Zocor and is also available in generic formulations. Simvastatin is also available in combination with ezetimibe (Vytorin) and in combination with niacin (Simcor).

"We want to ensure that patients and health care professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80-mg dose of simvastatin," Dr. Eric Colman, deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research said in the statement.

The changes are based on the FDA’s review of a 7-year study that found a greater risk of myopathy and rhabdomyolysis (none were fatal) among MI survivors who were treated with 80 mg of simvastatin, compared with those on the 20-mg dosage, and adverse events reported to the FDA’s MedWatch program. In the study, the risk of myopathy was highest during the first 12 months of treatment; an older age, female gender, concomitant use of a calcium channel blocker (Diltiazem in particular) and the presence of a genetic variant that increases plasma levels of simvastatin were also associated with a greater risk of myopathy, defined as unexplained muscle weakness or pain and a serum creatine kinase 10 times the upper limit of normal (JAMA 2004;292:2585-90).

Among the MedWatch reports, there was a higher rate of fatal rhabdomyolysis with the 80-mg dose, compared with lower doses of simvastatin and with other statins.

The recommendations have been incorporated into the label of these products, including the contraindications section. About 2.1 million patients in the United States were prescribed a product that contained 80 mg of simvastatin in 2010, according to the FDA.

The FDA statement is available at www.fda.gov/Drugs/DrugSafety/ucm256581.htm.

Adverse events associated with products that contain simvastatin should be reported online at the FDA’s MedWatch program or by phone at 800-332-1088.

A recommendation against prescribing the highest available dose of simvastatin is among the changes in the labeling information for the drug, the Food and Drug Administration announced on June 8.

The 80-mg dose of simvastatin has been associated with an elevated risk of myopathy, particularly during the first 12 months of treatment, so the FDA is now recommending that this dose be used only for patients who have been taking this dose for 12 months or longer and have not had any signs of myopathy, according to a statement issued by the agency.

The increased risk of myopathy with this dose is also often related to interactions with some medications and a genetic predisposition towards simvastatin-related myopathy, the statement said.

The FDA is also advising health care professionals not to start new patients on this dose and to prescribe alternative LDL cholesterol–lowering drugs for patients who do not meet their LDL-cholesterol goal on the 40-mg dose of simvastatin.The 80-mg dose lowers LDL cholesterol by an additional 6% over the 40-mg dose, the statement said.

The 80-mg dose is the highest dose approved for simvastatin, which is marketed as Zocor and is also available in generic formulations. Simvastatin is also available in combination with ezetimibe (Vytorin) and in combination with niacin (Simcor).

"We want to ensure that patients and health care professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80-mg dose of simvastatin," Dr. Eric Colman, deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research said in the statement.

The changes are based on the FDA’s review of a 7-year study that found a greater risk of myopathy and rhabdomyolysis (none were fatal) among MI survivors who were treated with 80 mg of simvastatin, compared with those on the 20-mg dosage, and adverse events reported to the FDA’s MedWatch program. In the study, the risk of myopathy was highest during the first 12 months of treatment; an older age, female gender, concomitant use of a calcium channel blocker (Diltiazem in particular) and the presence of a genetic variant that increases plasma levels of simvastatin were also associated with a greater risk of myopathy, defined as unexplained muscle weakness or pain and a serum creatine kinase 10 times the upper limit of normal (JAMA 2004;292:2585-90).

Among the MedWatch reports, there was a higher rate of fatal rhabdomyolysis with the 80-mg dose, compared with lower doses of simvastatin and with other statins.

The recommendations have been incorporated into the label of these products, including the contraindications section. About 2.1 million patients in the United States were prescribed a product that contained 80 mg of simvastatin in 2010, according to the FDA.

The FDA statement is available at www.fda.gov/Drugs/DrugSafety/ucm256581.htm.

Adverse events associated with products that contain simvastatin should be reported online at the FDA’s MedWatch program or by phone at 800-332-1088.

A recommendation against prescribing the highest available dose of simvastatin is among the changes in the labeling information for the drug, the Food and Drug Administration announced on June 8.

The 80-mg dose of simvastatin has been associated with an elevated risk of myopathy, particularly during the first 12 months of treatment, so the FDA is now recommending that this dose be used only for patients who have been taking this dose for 12 months or longer and have not had any signs of myopathy, according to a statement issued by the agency.

The increased risk of myopathy with this dose is also often related to interactions with some medications and a genetic predisposition towards simvastatin-related myopathy, the statement said.

The FDA is also advising health care professionals not to start new patients on this dose and to prescribe alternative LDL cholesterol–lowering drugs for patients who do not meet their LDL-cholesterol goal on the 40-mg dose of simvastatin.The 80-mg dose lowers LDL cholesterol by an additional 6% over the 40-mg dose, the statement said.

The 80-mg dose is the highest dose approved for simvastatin, which is marketed as Zocor and is also available in generic formulations. Simvastatin is also available in combination with ezetimibe (Vytorin) and in combination with niacin (Simcor).

"We want to ensure that patients and health care professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80-mg dose of simvastatin," Dr. Eric Colman, deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research said in the statement.

The changes are based on the FDA’s review of a 7-year study that found a greater risk of myopathy and rhabdomyolysis (none were fatal) among MI survivors who were treated with 80 mg of simvastatin, compared with those on the 20-mg dosage, and adverse events reported to the FDA’s MedWatch program. In the study, the risk of myopathy was highest during the first 12 months of treatment; an older age, female gender, concomitant use of a calcium channel blocker (Diltiazem in particular) and the presence of a genetic variant that increases plasma levels of simvastatin were also associated with a greater risk of myopathy, defined as unexplained muscle weakness or pain and a serum creatine kinase 10 times the upper limit of normal (JAMA 2004;292:2585-90).

Among the MedWatch reports, there was a higher rate of fatal rhabdomyolysis with the 80-mg dose, compared with lower doses of simvastatin and with other statins.

The recommendations have been incorporated into the label of these products, including the contraindications section. About 2.1 million patients in the United States were prescribed a product that contained 80 mg of simvastatin in 2010, according to the FDA.

The FDA statement is available at www.fda.gov/Drugs/DrugSafety/ucm256581.htm.

Adverse events associated with products that contain simvastatin should be reported online at the FDA’s MedWatch program or by phone at 800-332-1088.

A recommendation against prescribing the highest available dose of simvastatin is among the changes in the labeling information for the drug, the Food and Drug Administration announced on June 8.

The 80-mg dose of simvastatin has been associated with an elevated risk of myopathy, particularly during the first 12 months of treatment, so the FDA is now recommending that this dose be used only for patients who have been taking this dose for 12 months or longer and have not had any signs of myopathy, according to a statement issued by the agency.

The increased risk of myopathy with this dose is also often related to interactions with some medications and a genetic predisposition towards simvastatin-related myopathy, the statement said.

The FDA is also advising health care professionals not to start new patients on this dose and to prescribe alternative LDL cholesterol–lowering drugs for patients who do not meet their LDL-cholesterol goal on the 40-mg dose of simvastatin.The 80-mg dose lowers LDL cholesterol by an additional 6% over the 40-mg dose, the statement said.

The 80-mg dose is the highest dose approved for simvastatin, which is marketed as Zocor and is also available in generic formulations. Simvastatin is also available in combination with ezetimibe (Vytorin) and in combination with niacin (Simcor).

"We want to ensure that patients and health care professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80-mg dose of simvastatin," Dr. Eric Colman, deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research said in the statement.

The changes are based on the FDA’s review of a 7-year study that found a greater risk of myopathy and rhabdomyolysis (none were fatal) among MI survivors who were treated with 80 mg of simvastatin, compared with those on the 20-mg dosage, and adverse events reported to the FDA’s MedWatch program. In the study, the risk of myopathy was highest during the first 12 months of treatment; an older age, female gender, concomitant use of a calcium channel blocker (Diltiazem in particular) and the presence of a genetic variant that increases plasma levels of simvastatin were also associated with a greater risk of myopathy, defined as unexplained muscle weakness or pain and a serum creatine kinase 10 times the upper limit of normal (JAMA 2004;292:2585-90).

Among the MedWatch reports, there was a higher rate of fatal rhabdomyolysis with the 80-mg dose, compared with lower doses of simvastatin and with other statins.

The recommendations have been incorporated into the label of these products, including the contraindications section. About 2.1 million patients in the United States were prescribed a product that contained 80 mg of simvastatin in 2010, according to the FDA.

The FDA statement is available at www.fda.gov/Drugs/DrugSafety/ucm256581.htm.

Adverse events associated with products that contain simvastatin should be reported online at the FDA’s MedWatch program or by phone at 800-332-1088.

A recommendation against prescribing the highest available dose of simvastatin is among the changes in the labeling information for the drug, the Food and Drug Administration announced on June 8.

The 80-mg dose of simvastatin has been associated with an elevated risk of myopathy, particularly during the first 12 months of treatment, so the FDA is now recommending that this dose be used only for patients who have been taking this dose for 12 months or longer and have not had any signs of myopathy, according to a statement issued by the agency.

The increased risk of myopathy with this dose is also often related to interactions with some medications and a genetic predisposition towards simvastatin-related myopathy, the statement said.

The FDA is also advising health care professionals not to start new patients on this dose and to prescribe alternative LDL cholesterol–lowering drugs for patients who do not meet their LDL-cholesterol goal on the 40-mg dose of simvastatin.The 80-mg dose lowers LDL cholesterol by an additional 6% over the 40-mg dose, the statement said.

The 80-mg dose is the highest dose approved for simvastatin, which is marketed as Zocor and is also available in generic formulations. Simvastatin is also available in combination with ezetimibe (Vytorin) and in combination with niacin (Simcor).

"We want to ensure that patients and health care professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80-mg dose of simvastatin," Dr. Eric Colman, deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research said in the statement.

The changes are based on the FDA’s review of a 7-year study that found a greater risk of myopathy and rhabdomyolysis (none were fatal) among MI survivors who were treated with 80 mg of simvastatin, compared with those on the 20-mg dosage, and adverse events reported to the FDA’s MedWatch program. In the study, the risk of myopathy was highest during the first 12 months of treatment; an older age, female gender, concomitant use of a calcium channel blocker (Diltiazem in particular) and the presence of a genetic variant that increases plasma levels of simvastatin were also associated with a greater risk of myopathy, defined as unexplained muscle weakness or pain and a serum creatine kinase 10 times the upper limit of normal (JAMA 2004;292:2585-90).

Among the MedWatch reports, there was a higher rate of fatal rhabdomyolysis with the 80-mg dose, compared with lower doses of simvastatin and with other statins.

The recommendations have been incorporated into the label of these products, including the contraindications section. About 2.1 million patients in the United States were prescribed a product that contained 80 mg of simvastatin in 2010, according to the FDA.

The FDA statement is available at www.fda.gov/Drugs/DrugSafety/ucm256581.htm.

Adverse events associated with products that contain simvastatin should be reported online at the FDA’s MedWatch program or by phone at 800-332-1088.

A recommendation against prescribing the highest available dose of simvastatin is among the changes in the labeling information for the drug, the Food and Drug Administration announced on June 8.

The 80-mg dose of simvastatin has been associated with an elevated risk of myopathy, particularly during the first 12 months of treatment, so the FDA is now recommending that this dose be used only for patients who have been taking this dose for 12 months or longer and have not had any signs of myopathy, according to a statement issued by the agency.

The increased risk of myopathy with this dose is also often related to interactions with some medications and a genetic predisposition towards simvastatin-related myopathy, the statement said.

The FDA is also advising health care professionals not to start new patients on this dose and to prescribe alternative LDL cholesterol–lowering drugs for patients who do not meet their LDL-cholesterol goal on the 40-mg dose of simvastatin.The 80-mg dose lowers LDL cholesterol by an additional 6% over the 40-mg dose, the statement said.

The 80-mg dose is the highest dose approved for simvastatin, which is marketed as Zocor and is also available in generic formulations. Simvastatin is also available in combination with ezetimibe (Vytorin) and in combination with niacin (Simcor).

"We want to ensure that patients and health care professionals are aware of the new labeling changes to simvastatin, including the increased risk of myopathy when using the 80-mg dose of simvastatin," Dr. Eric Colman, deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research said in the statement.

The changes are based on the FDA’s review of a 7-year study that found a greater risk of myopathy and rhabdomyolysis (none were fatal) among MI survivors who were treated with 80 mg of simvastatin, compared with those on the 20-mg dosage, and adverse events reported to the FDA’s MedWatch program. In the study, the risk of myopathy was highest during the first 12 months of treatment; an older age, female gender, concomitant use of a calcium channel blocker (Diltiazem in particular) and the presence of a genetic variant that increases plasma levels of simvastatin were also associated with a greater risk of myopathy, defined as unexplained muscle weakness or pain and a serum creatine kinase 10 times the upper limit of normal (JAMA 2004;292:2585-90).

Among the MedWatch reports, there was a higher rate of fatal rhabdomyolysis with the 80-mg dose, compared with lower doses of simvastatin and with other statins.

The recommendations have been incorporated into the label of these products, including the contraindications section. About 2.1 million patients in the United States were prescribed a product that contained 80 mg of simvastatin in 2010, according to the FDA.

The FDA statement is available at www.fda.gov/Drugs/DrugSafety/ucm256581.htm.

Adverse events associated with products that contain simvastatin should be reported online at the FDA’s MedWatch program or by phone at 800-332-1088.

Treatment with angiotensin receptor blockers is not associated with an increased risk of cancer, according to a Food and Drug Administration meta-analysis that the agency called the largest ever to examine a possible association.

"Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer," the agency said in a drug safety communication issued June 2.

There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten). They are also available in combination with hydrochlorothiazide and/or amlodipine; valsartan is also available in combination with aliskiren.

In July 2010, the FDA announced it would conduct a safety review of ARBs, after a meta-analysis of five randomized studies that included about 62,000 people found a small but statistically significant increase in the risk of cancer associated with the use of ARBs (Lancet Oncol. 2010:11;627-36).

The FDA subsequently conducted a meta-analysis of 31 studies including nearly 156,000 patients randomized to an ARB (84,461 patients) or a non-ARB comparator (71,355 patients) who were followed for an average of 3 years and 3 months.

That meta-analysis "found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs," the FDA statement said.

The meta-analysis involved studies that included more than 100 patients, that lasted for at least 1 year, and that included cancer or cancer deaths as a prespecified end point or adverse event.

The FDA statement referred to three recently published studies, which also did not suggest an increased risk of cancer associated with the use of an ARB.

Health professionals should report serious adverse events associated with ARBs to the MedWatch program at 800-332-1088 or www.fda.gov/medwatch.

Treatment with angiotensin receptor blockers is not associated with an increased risk of cancer, according to a Food and Drug Administration meta-analysis that the agency called the largest ever to examine a possible association.

"Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer," the agency said in a drug safety communication issued June 2.

There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten). They are also available in combination with hydrochlorothiazide and/or amlodipine; valsartan is also available in combination with aliskiren.

In July 2010, the FDA announced it would conduct a safety review of ARBs, after a meta-analysis of five randomized studies that included about 62,000 people found a small but statistically significant increase in the risk of cancer associated with the use of ARBs (Lancet Oncol. 2010:11;627-36).

The FDA subsequently conducted a meta-analysis of 31 studies including nearly 156,000 patients randomized to an ARB (84,461 patients) or a non-ARB comparator (71,355 patients) who were followed for an average of 3 years and 3 months.

That meta-analysis "found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs," the FDA statement said.

The meta-analysis involved studies that included more than 100 patients, that lasted for at least 1 year, and that included cancer or cancer deaths as a prespecified end point or adverse event.

The FDA statement referred to three recently published studies, which also did not suggest an increased risk of cancer associated with the use of an ARB.

Health professionals should report serious adverse events associated with ARBs to the MedWatch program at 800-332-1088 or www.fda.gov/medwatch.

Treatment with angiotensin receptor blockers is not associated with an increased risk of cancer, according to a Food and Drug Administration meta-analysis that the agency called the largest ever to examine a possible association.

"Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer," the agency said in a drug safety communication issued June 2.

There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten). They are also available in combination with hydrochlorothiazide and/or amlodipine; valsartan is also available in combination with aliskiren.

In July 2010, the FDA announced it would conduct a safety review of ARBs, after a meta-analysis of five randomized studies that included about 62,000 people found a small but statistically significant increase in the risk of cancer associated with the use of ARBs (Lancet Oncol. 2010:11;627-36).

The FDA subsequently conducted a meta-analysis of 31 studies including nearly 156,000 patients randomized to an ARB (84,461 patients) or a non-ARB comparator (71,355 patients) who were followed for an average of 3 years and 3 months.

That meta-analysis "found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs," the FDA statement said.

The meta-analysis involved studies that included more than 100 patients, that lasted for at least 1 year, and that included cancer or cancer deaths as a prespecified end point or adverse event.

The FDA statement referred to three recently published studies, which also did not suggest an increased risk of cancer associated with the use of an ARB.

Health professionals should report serious adverse events associated with ARBs to the MedWatch program at 800-332-1088 or www.fda.gov/medwatch.

Treatment with angiotensin receptor blockers is not associated with an increased risk of cancer, according to a Food and Drug Administration meta-analysis that the agency called the largest ever to examine a possible association.

"Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer," the agency said in a drug safety communication issued June 2.

There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten). They are also available in combination with hydrochlorothiazide and/or amlodipine; valsartan is also available in combination with aliskiren.

In July 2010, the FDA announced it would conduct a safety review of ARBs, after a meta-analysis of five randomized studies that included about 62,000 people found a small but statistically significant increase in the risk of cancer associated with the use of ARBs (Lancet Oncol. 2010:11;627-36).

The FDA subsequently conducted a meta-analysis of 31 studies including nearly 156,000 patients randomized to an ARB (84,461 patients) or a non-ARB comparator (71,355 patients) who were followed for an average of 3 years and 3 months.

That meta-analysis "found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs," the FDA statement said.

The meta-analysis involved studies that included more than 100 patients, that lasted for at least 1 year, and that included cancer or cancer deaths as a prespecified end point or adverse event.

The FDA statement referred to three recently published studies, which also did not suggest an increased risk of cancer associated with the use of an ARB.

Health professionals should report serious adverse events associated with ARBs to the MedWatch program at 800-332-1088 or www.fda.gov/medwatch.

Treatment with angiotensin receptor blockers is not associated with an increased risk of cancer, according to a Food and Drug Administration meta-analysis that the agency called the largest ever to examine a possible association.

"Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer," the agency said in a drug safety communication issued June 2.

There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten). They are also available in combination with hydrochlorothiazide and/or amlodipine; valsartan is also available in combination with aliskiren.

In July 2010, the FDA announced it would conduct a safety review of ARBs, after a meta-analysis of five randomized studies that included about 62,000 people found a small but statistically significant increase in the risk of cancer associated with the use of ARBs (Lancet Oncol. 2010:11;627-36).

The FDA subsequently conducted a meta-analysis of 31 studies including nearly 156,000 patients randomized to an ARB (84,461 patients) or a non-ARB comparator (71,355 patients) who were followed for an average of 3 years and 3 months.

That meta-analysis "found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs," the FDA statement said.

The meta-analysis involved studies that included more than 100 patients, that lasted for at least 1 year, and that included cancer or cancer deaths as a prespecified end point or adverse event.

The FDA statement referred to three recently published studies, which also did not suggest an increased risk of cancer associated with the use of an ARB.

Health professionals should report serious adverse events associated with ARBs to the MedWatch program at 800-332-1088 or www.fda.gov/medwatch.

Treatment with angiotensin receptor blockers is not associated with an increased risk of cancer, according to a Food and Drug Administration meta-analysis that the agency called the largest ever to examine a possible association.

"Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer," the agency said in a drug safety communication issued June 2.

There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten). They are also available in combination with hydrochlorothiazide and/or amlodipine; valsartan is also available in combination with aliskiren.

In July 2010, the FDA announced it would conduct a safety review of ARBs, after a meta-analysis of five randomized studies that included about 62,000 people found a small but statistically significant increase in the risk of cancer associated with the use of ARBs (Lancet Oncol. 2010:11;627-36).

The FDA subsequently conducted a meta-analysis of 31 studies including nearly 156,000 patients randomized to an ARB (84,461 patients) or a non-ARB comparator (71,355 patients) who were followed for an average of 3 years and 3 months.

That meta-analysis "found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs," the FDA statement said.

The meta-analysis involved studies that included more than 100 patients, that lasted for at least 1 year, and that included cancer or cancer deaths as a prespecified end point or adverse event.

The FDA statement referred to three recently published studies, which also did not suggest an increased risk of cancer associated with the use of an ARB.

Health professionals should report serious adverse events associated with ARBs to the MedWatch program at 800-332-1088 or www.fda.gov/medwatch.

Treatment with angiotensin receptor blockers is not associated with an increased risk of cancer, according to a Food and Drug Administration meta-analysis that the agency called the largest ever to examine a possible association.

"Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer," the agency said in a drug safety communication issued June 2.

There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten). They are also available in combination with hydrochlorothiazide and/or amlodipine; valsartan is also available in combination with aliskiren.

In July 2010, the FDA announced it would conduct a safety review of ARBs, after a meta-analysis of five randomized studies that included about 62,000 people found a small but statistically significant increase in the risk of cancer associated with the use of ARBs (Lancet Oncol. 2010:11;627-36).

The FDA subsequently conducted a meta-analysis of 31 studies including nearly 156,000 patients randomized to an ARB (84,461 patients) or a non-ARB comparator (71,355 patients) who were followed for an average of 3 years and 3 months.

That meta-analysis "found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs," the FDA statement said.

The meta-analysis involved studies that included more than 100 patients, that lasted for at least 1 year, and that included cancer or cancer deaths as a prespecified end point or adverse event.

The FDA statement referred to three recently published studies, which also did not suggest an increased risk of cancer associated with the use of an ARB.

Health professionals should report serious adverse events associated with ARBs to the MedWatch program at 800-332-1088 or www.fda.gov/medwatch.

Treatment with angiotensin receptor blockers is not associated with an increased risk of cancer, according to a Food and Drug Administration meta-analysis that the agency called the largest ever to examine a possible association.

"Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer," the agency said in a drug safety communication issued June 2.

There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten). They are also available in combination with hydrochlorothiazide and/or amlodipine; valsartan is also available in combination with aliskiren.

In July 2010, the FDA announced it would conduct a safety review of ARBs, after a meta-analysis of five randomized studies that included about 62,000 people found a small but statistically significant increase in the risk of cancer associated with the use of ARBs (Lancet Oncol. 2010:11;627-36).

The FDA subsequently conducted a meta-analysis of 31 studies including nearly 156,000 patients randomized to an ARB (84,461 patients) or a non-ARB comparator (71,355 patients) who were followed for an average of 3 years and 3 months.

That meta-analysis "found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs," the FDA statement said.

The meta-analysis involved studies that included more than 100 patients, that lasted for at least 1 year, and that included cancer or cancer deaths as a prespecified end point or adverse event.

The FDA statement referred to three recently published studies, which also did not suggest an increased risk of cancer associated with the use of an ARB.

Health professionals should report serious adverse events associated with ARBs to the MedWatch program at 800-332-1088 or www.fda.gov/medwatch.

Treatment with angiotensin receptor blockers is not associated with an increased risk of cancer, according to a Food and Drug Administration meta-analysis that the agency called the largest ever to examine a possible association.

"Based on our review and analysis of all currently available data regarding this potential safety signal, FDA has concluded that treatment with an ARB medication does not increase the risk of cancer," the agency said in a drug safety communication issued June 2.

There are seven single-ingredient ARBs approved by the FDA for treating hypertension: candesartan (Atacand), irbesartan (Avapro), olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten). They are also available in combination with hydrochlorothiazide and/or amlodipine; valsartan is also available in combination with aliskiren.

In July 2010, the FDA announced it would conduct a safety review of ARBs, after a meta-analysis of five randomized studies that included about 62,000 people found a small but statistically significant increase in the risk of cancer associated with the use of ARBs (Lancet Oncol. 2010:11;627-36).

The FDA subsequently conducted a meta-analysis of 31 studies including nearly 156,000 patients randomized to an ARB (84,461 patients) or a non-ARB comparator (71,355 patients) who were followed for an average of 3 years and 3 months.

That meta-analysis "found no evidence of an increased risk of incident (new) cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs," the FDA statement said.

The meta-analysis involved studies that included more than 100 patients, that lasted for at least 1 year, and that included cancer or cancer deaths as a prespecified end point or adverse event.

The FDA statement referred to three recently published studies, which also did not suggest an increased risk of cancer associated with the use of an ARB.

Health professionals should report serious adverse events associated with ARBs to the MedWatch program at 800-332-1088 or www.fda.gov/medwatch.

An estimated 50,000 people are infected with HIV every year in the United States, despite successful efforts to prevent HIV infections and a marked drop in deaths since the epidemic began 30 years ago, according to a report from the Centers for Disease Control and Prevention.

Moreover, about 20% of people infected with HIV are undiagnosed, according to the report on HIV surveillance in the United States between 1981 and 2008, which appeared in the June 3 issue of Morbidity and Mortality Weekly Report (MMWR 2011;60:689-93).

The report summarizes the findings of the CDC’s analysis of data from the National HIV Surveillance System of HIV and AIDS cases in people aged 13 years and older, between 1981, the beginning of the AIDS epidemic, and 2008.

The estimated number of people aged 13 years and older newly diagnosed with AIDS every year rapidly increased from 1981 to 1992, from 318 in 1981, peaking at 75,457 in 1992. The estimated number of AIDS-related deaths also increased, from 451 in 1981, peaking at 50,628 in 1995.

This was followed by a marked drop in AIDS diagnoses and deaths from 1995 to 1998, after highly-active antiretroviral drugs became available, and in 1999, the number of new cases and deaths started to stabilize. Between 1999 and 2008, there was an average of 38,279 diagnoses and 17,489 deaths per year. In addition, the estimated number of people aged 13 years and older who were living with AIDS increased from 219,318 in 1996 to 479,161 in 2008, more than a twofold increase.

Still, the report pointed out, an estimated 1,178,350 people at the end of 2008 were living with HIV, about 20% of whom were undiagnosed. These findings "underscore the importance of the national HIV/AIDS Strategy focus on reducing HIV risk behaviors, increasing opportunities for routine testing and enhancing use of care." Of those living with HIV at the end of 2008, 75% were men; of the men, almost 66% were men who have sex with men.

The report also finds disparities between races and ethnic groups: The prevalence of HIV was about eightfold higher among blacks and about 2.5 times higher among Hispanics than among whites. And Asians or Pacific Islanders, and American Indians or Alaska natives accounted for a higher proportion of those with undiagnosed HIV infections (as did men with high-risk heterosexual contacts) than among blacks, whites, or Hispanics.

An editorial note accompanying the report points out that HIV prevention efforts have prevented an estimated 350,000 HIV infections during 1991-2006, at a savings of $125 billion in medical costs.

More than half of the estimated 50,000 people who are infected every year in the United States are men who have sex with men, and almost half are black.

But the proportion of men who have sex with men who are diagnosed with HIV continues to increase, and has increased steadily since the early 1990s, and late diagnoses of HIV are common, according to the editorial note. Of the newly diagnosed HIV cases in 2008, 33% were diagnosed with AIDS within 1 year of the HIV diagnosis, and were "likely" infected an average of 10 years before being diagnosed – during which time, "they missed opportunities to obtain medical care and to prevent unwitting transmission of HIV to others," the editorial noted.

The report and editorial note ends by pointing out that the National HIV/AIDS Strategy is refocusing efforts to increase HIV prevention efforts in communities with the highest prevalence of HIV infection, "using a combination of effective strategies that seek to optimize entry into and retention in care and maintenance of viral suppression."

"Over the last three decades, prevention efforts have helped reduce new infections and treatment advances have allowed people with HIV to live longer, healthier lives," CDC Director Dr. Thomas Frieden said in a statement issued on June 2.. "But as these improvements have taken place, our nation’s collective sense of crisis has waned. Far too many Americans underestimate their risk of infection or believe HIV is no longer a serious health threat, but they must understand that HIV remains an incurable infection. We must increase our resolve to end this epidemic."

An estimated 50,000 people are infected with HIV every year in the United States, despite successful efforts to prevent HIV infections and a marked drop in deaths since the epidemic began 30 years ago, according to a report from the Centers for Disease Control and Prevention.

Moreover, about 20% of people infected with HIV are undiagnosed, according to the report on HIV surveillance in the United States between 1981 and 2008, which appeared in the June 3 issue of Morbidity and Mortality Weekly Report (MMWR 2011;60:689-93).

The report summarizes the findings of the CDC’s analysis of data from the National HIV Surveillance System of HIV and AIDS cases in people aged 13 years and older, between 1981, the beginning of the AIDS epidemic, and 2008.

The estimated number of people aged 13 years and older newly diagnosed with AIDS every year rapidly increased from 1981 to 1992, from 318 in 1981, peaking at 75,457 in 1992. The estimated number of AIDS-related deaths also increased, from 451 in 1981, peaking at 50,628 in 1995.

This was followed by a marked drop in AIDS diagnoses and deaths from 1995 to 1998, after highly-active antiretroviral drugs became available, and in 1999, the number of new cases and deaths started to stabilize. Between 1999 and 2008, there was an average of 38,279 diagnoses and 17,489 deaths per year. In addition, the estimated number of people aged 13 years and older who were living with AIDS increased from 219,318 in 1996 to 479,161 in 2008, more than a twofold increase.

Still, the report pointed out, an estimated 1,178,350 people at the end of 2008 were living with HIV, about 20% of whom were undiagnosed. These findings "underscore the importance of the national HIV/AIDS Strategy focus on reducing HIV risk behaviors, increasing opportunities for routine testing and enhancing use of care." Of those living with HIV at the end of 2008, 75% were men; of the men, almost 66% were men who have sex with men.

The report also finds disparities between races and ethnic groups: The prevalence of HIV was about eightfold higher among blacks and about 2.5 times higher among Hispanics than among whites. And Asians or Pacific Islanders, and American Indians or Alaska natives accounted for a higher proportion of those with undiagnosed HIV infections (as did men with high-risk heterosexual contacts) than among blacks, whites, or Hispanics.

An editorial note accompanying the report points out that HIV prevention efforts have prevented an estimated 350,000 HIV infections during 1991-2006, at a savings of $125 billion in medical costs.

More than half of the estimated 50,000 people who are infected every year in the United States are men who have sex with men, and almost half are black.

But the proportion of men who have sex with men who are diagnosed with HIV continues to increase, and has increased steadily since the early 1990s, and late diagnoses of HIV are common, according to the editorial note. Of the newly diagnosed HIV cases in 2008, 33% were diagnosed with AIDS within 1 year of the HIV diagnosis, and were "likely" infected an average of 10 years before being diagnosed – during which time, "they missed opportunities to obtain medical care and to prevent unwitting transmission of HIV to others," the editorial noted.

The report and editorial note ends by pointing out that the National HIV/AIDS Strategy is refocusing efforts to increase HIV prevention efforts in communities with the highest prevalence of HIV infection, "using a combination of effective strategies that seek to optimize entry into and retention in care and maintenance of viral suppression."

"Over the last three decades, prevention efforts have helped reduce new infections and treatment advances have allowed people with HIV to live longer, healthier lives," CDC Director Dr. Thomas Frieden said in a statement issued on June 2.. "But as these improvements have taken place, our nation’s collective sense of crisis has waned. Far too many Americans underestimate their risk of infection or believe HIV is no longer a serious health threat, but they must understand that HIV remains an incurable infection. We must increase our resolve to end this epidemic."

An estimated 50,000 people are infected with HIV every year in the United States, despite successful efforts to prevent HIV infections and a marked drop in deaths since the epidemic began 30 years ago, according to a report from the Centers for Disease Control and Prevention.

Moreover, about 20% of people infected with HIV are undiagnosed, according to the report on HIV surveillance in the United States between 1981 and 2008, which appeared in the June 3 issue of Morbidity and Mortality Weekly Report (MMWR 2011;60:689-93).

The report summarizes the findings of the CDC’s analysis of data from the National HIV Surveillance System of HIV and AIDS cases in people aged 13 years and older, between 1981, the beginning of the AIDS epidemic, and 2008.

The estimated number of people aged 13 years and older newly diagnosed with AIDS every year rapidly increased from 1981 to 1992, from 318 in 1981, peaking at 75,457 in 1992. The estimated number of AIDS-related deaths also increased, from 451 in 1981, peaking at 50,628 in 1995.

This was followed by a marked drop in AIDS diagnoses and deaths from 1995 to 1998, after highly-active antiretroviral drugs became available, and in 1999, the number of new cases and deaths started to stabilize. Between 1999 and 2008, there was an average of 38,279 diagnoses and 17,489 deaths per year. In addition, the estimated number of people aged 13 years and older who were living with AIDS increased from 219,318 in 1996 to 479,161 in 2008, more than a twofold increase.

Still, the report pointed out, an estimated 1,178,350 people at the end of 2008 were living with HIV, about 20% of whom were undiagnosed. These findings "underscore the importance of the national HIV/AIDS Strategy focus on reducing HIV risk behaviors, increasing opportunities for routine testing and enhancing use of care." Of those living with HIV at the end of 2008, 75% were men; of the men, almost 66% were men who have sex with men.

The report also finds disparities between races and ethnic groups: The prevalence of HIV was about eightfold higher among blacks and about 2.5 times higher among Hispanics than among whites. And Asians or Pacific Islanders, and American Indians or Alaska natives accounted for a higher proportion of those with undiagnosed HIV infections (as did men with high-risk heterosexual contacts) than among blacks, whites, or Hispanics.

An editorial note accompanying the report points out that HIV prevention efforts have prevented an estimated 350,000 HIV infections during 1991-2006, at a savings of $125 billion in medical costs.

More than half of the estimated 50,000 people who are infected every year in the United States are men who have sex with men, and almost half are black.

But the proportion of men who have sex with men who are diagnosed with HIV continues to increase, and has increased steadily since the early 1990s, and late diagnoses of HIV are common, according to the editorial note. Of the newly diagnosed HIV cases in 2008, 33% were diagnosed with AIDS within 1 year of the HIV diagnosis, and were "likely" infected an average of 10 years before being diagnosed – during which time, "they missed opportunities to obtain medical care and to prevent unwitting transmission of HIV to others," the editorial noted.

The report and editorial note ends by pointing out that the National HIV/AIDS Strategy is refocusing efforts to increase HIV prevention efforts in communities with the highest prevalence of HIV infection, "using a combination of effective strategies that seek to optimize entry into and retention in care and maintenance of viral suppression."

"Over the last three decades, prevention efforts have helped reduce new infections and treatment advances have allowed people with HIV to live longer, healthier lives," CDC Director Dr. Thomas Frieden said in a statement issued on June 2.. "But as these improvements have taken place, our nation’s collective sense of crisis has waned. Far too many Americans underestimate their risk of infection or believe HIV is no longer a serious health threat, but they must understand that HIV remains an incurable infection. We must increase our resolve to end this epidemic."