AUDIENCE:
Cardiology, Urology, Family Practice
ISSUE:
FDA 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. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete.
BACKGROUND:
Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.
RECOMMENDATION:
At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Sources and Studies:
- FDA Safety Information ucm384225 01/31/2014
- FDA Drug Safety Communication ucm383904 01/31/2014
- PLOS One January 29, 2014 DOI: 10.1371/journal.pone.0085805
Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men - JAMA. 1764051 2013;310(17):1829-1836. doi:10.1001/jama.2013.280386 Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels November 6, 2013
- “These newer studies have prompted some to ask for warnings on testosterone therapy and to educate their patients on possible increased risks of heart disease. Doctors are the ones who need more education here.” Testosterone Therapy Does Not Cause Heart Attacks, HuffingtonPost, by Jen Landa, M.D. 02/04/2014