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The Food and Drug Administration is reassessing the cardiovascular safety of approved testosterone treatments and urged physicians and patients to report side effects.
Two recent observational studies that reported increased risks of MI, stroke, and death in men taking prescribed testosterone products prompted the FDA to open its investigation and to publish the alert about its actions.
Patients on prescribed testosterone products should not discontinue them without talking with their health care providers, the FDA cautioned. The agency has not concluded that approved testosterone formulations increase cardiovascular risk. Final recommendations are pending the completion of its evaluation.
The risk of MI doubled within 90 days of starting testosterone, compared with the previous year, in men aged 65 years or older and nearly tripled in younger men who had a prior history of heart disease, a cohort study of claims data for 55,593 men reported (PLoS ONE 2015 Jan. 29 [doi: 10.1371/journal.pone.0085805]).
Younger men with no history of heart disease showed no increased cardiovascular risk after filling a testosterone prescription, William D. Finkle and his associates reported. The National Cancer Institute funded the study. Mr. Finkle is owner of Consolidated Research, Los Angeles, a company that develops statistical methods and software. He and his associates reported having no relevant financial disclosures.
A separate retrospective cohort study of 8,709 men with low testosterone levels, 1,223 of whom were treated with testosterone, found a 30% increased risk for MI, stroke, or death within 1 year of starting testosterone compared with the men not on testosterone. The relative risk was threefold higher at 2 years and nearly sixfold higher at 3 years, reported Dr. Rebecca Vigen of the University of Texas at Southwestern Medical Center, Dallas, and her associates (JAMA 2013;310:1829-36).
The elevated risk with testosterone therapy was seen both in men who had existing coronary artery disease and in those who did not, and the risk did not appear to be affected by differences in cardiovascular risk factors such as blood pressure or by the use of preventive medications.
The Department of Veterans Affairs funded the study. Dr. Vigen and her associates reported having no relevant financial disclosures.
An earlier clinical trial of testosterone therapy in older men that included many men with cardiovascular disorders was halted early after an increase in cardiovascular events in the testosterone group compared with the placebo group was found, the National Institutes of Health reported in 2010.
The FDA urged health care professionals and patients to report side effects involving testosterone products to the FDA MedWatch program by filing a report online, calling 800-332-1088, or faxing to 800-FDA-0178.
FDA-approved testosterone products deliver the hormone by topical gel, transdermal patch, buccal system, and injection, and are indicated only for men with low or no testosterone levels associated with a medical condition. No testosterone products are approved to treat men with low testosterone levels that are not associated with a medical condition.
On Twitter @sherryboschert
The Food and Drug Administration is reassessing the cardiovascular safety of approved testosterone treatments and urged physicians and patients to report side effects.
Two recent observational studies that reported increased risks of MI, stroke, and death in men taking prescribed testosterone products prompted the FDA to open its investigation and to publish the alert about its actions.
Patients on prescribed testosterone products should not discontinue them without talking with their health care providers, the FDA cautioned. The agency has not concluded that approved testosterone formulations increase cardiovascular risk. Final recommendations are pending the completion of its evaluation.
The risk of MI doubled within 90 days of starting testosterone, compared with the previous year, in men aged 65 years or older and nearly tripled in younger men who had a prior history of heart disease, a cohort study of claims data for 55,593 men reported (PLoS ONE 2015 Jan. 29 [doi: 10.1371/journal.pone.0085805]).
Younger men with no history of heart disease showed no increased cardiovascular risk after filling a testosterone prescription, William D. Finkle and his associates reported. The National Cancer Institute funded the study. Mr. Finkle is owner of Consolidated Research, Los Angeles, a company that develops statistical methods and software. He and his associates reported having no relevant financial disclosures.
A separate retrospective cohort study of 8,709 men with low testosterone levels, 1,223 of whom were treated with testosterone, found a 30% increased risk for MI, stroke, or death within 1 year of starting testosterone compared with the men not on testosterone. The relative risk was threefold higher at 2 years and nearly sixfold higher at 3 years, reported Dr. Rebecca Vigen of the University of Texas at Southwestern Medical Center, Dallas, and her associates (JAMA 2013;310:1829-36).
The elevated risk with testosterone therapy was seen both in men who had existing coronary artery disease and in those who did not, and the risk did not appear to be affected by differences in cardiovascular risk factors such as blood pressure or by the use of preventive medications.
The Department of Veterans Affairs funded the study. Dr. Vigen and her associates reported having no relevant financial disclosures.
An earlier clinical trial of testosterone therapy in older men that included many men with cardiovascular disorders was halted early after an increase in cardiovascular events in the testosterone group compared with the placebo group was found, the National Institutes of Health reported in 2010.
The FDA urged health care professionals and patients to report side effects involving testosterone products to the FDA MedWatch program by filing a report online, calling 800-332-1088, or faxing to 800-FDA-0178.
FDA-approved testosterone products deliver the hormone by topical gel, transdermal patch, buccal system, and injection, and are indicated only for men with low or no testosterone levels associated with a medical condition. No testosterone products are approved to treat men with low testosterone levels that are not associated with a medical condition.
On Twitter @sherryboschert
The Food and Drug Administration is reassessing the cardiovascular safety of approved testosterone treatments and urged physicians and patients to report side effects.
Two recent observational studies that reported increased risks of MI, stroke, and death in men taking prescribed testosterone products prompted the FDA to open its investigation and to publish the alert about its actions.
Patients on prescribed testosterone products should not discontinue them without talking with their health care providers, the FDA cautioned. The agency has not concluded that approved testosterone formulations increase cardiovascular risk. Final recommendations are pending the completion of its evaluation.
The risk of MI doubled within 90 days of starting testosterone, compared with the previous year, in men aged 65 years or older and nearly tripled in younger men who had a prior history of heart disease, a cohort study of claims data for 55,593 men reported (PLoS ONE 2015 Jan. 29 [doi: 10.1371/journal.pone.0085805]).
Younger men with no history of heart disease showed no increased cardiovascular risk after filling a testosterone prescription, William D. Finkle and his associates reported. The National Cancer Institute funded the study. Mr. Finkle is owner of Consolidated Research, Los Angeles, a company that develops statistical methods and software. He and his associates reported having no relevant financial disclosures.
A separate retrospective cohort study of 8,709 men with low testosterone levels, 1,223 of whom were treated with testosterone, found a 30% increased risk for MI, stroke, or death within 1 year of starting testosterone compared with the men not on testosterone. The relative risk was threefold higher at 2 years and nearly sixfold higher at 3 years, reported Dr. Rebecca Vigen of the University of Texas at Southwestern Medical Center, Dallas, and her associates (JAMA 2013;310:1829-36).
The elevated risk with testosterone therapy was seen both in men who had existing coronary artery disease and in those who did not, and the risk did not appear to be affected by differences in cardiovascular risk factors such as blood pressure or by the use of preventive medications.
The Department of Veterans Affairs funded the study. Dr. Vigen and her associates reported having no relevant financial disclosures.
An earlier clinical trial of testosterone therapy in older men that included many men with cardiovascular disorders was halted early after an increase in cardiovascular events in the testosterone group compared with the placebo group was found, the National Institutes of Health reported in 2010.
The FDA urged health care professionals and patients to report side effects involving testosterone products to the FDA MedWatch program by filing a report online, calling 800-332-1088, or faxing to 800-FDA-0178.
FDA-approved testosterone products deliver the hormone by topical gel, transdermal patch, buccal system, and injection, and are indicated only for men with low or no testosterone levels associated with a medical condition. No testosterone products are approved to treat men with low testosterone levels that are not associated with a medical condition.
On Twitter @sherryboschert