Welcome to the FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug Information.
On January 31, 2014, FDA announced that it is investigating the risk of stroke, heart attack, and death in men taking FDA approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete.
At this time, FDA has not concluded that FDA approved testosterone treatment increases the risk of stroke, heart attack, or death. Health care professionals should consider whether the benefits of FDA approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.
Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Example conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with the hypothalamus and pituitary that control the testicles’ production of testosterone.
None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.
An observational study of older men in the U.S. Veteran Affairs health system published in the Journal of the American Medical Association in November 2013 prompted FDA to reassess the cardiovascular safety of testosterone therapy. This study suggested a 30 percent increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy.
A second observational study reported an increased risk of heart attack in older men 65 years and older, as well as younger men less than 65 years, with pre-existing heart disease, who filled a prescription for testosterone therapy.
Thank you for listening. A link to the full communication containing further details related to the observational studies and their references can be found at www.fda.gov/DrugSafetyCommunications. Please report side effects involving prescription testosterone products to FDA’s MedWatch program at www.fda.gov/medwatch.