The FDA has announced that all prescription testosterone (and other anabolic androgenic steroid) products will have changes made to the package inserts to reflect the published risks associated with testosterone abuse and dependence.

Serious adverse effects reported include cardiovascular (myocardial infarction, stroke, heart failure), psychiatric (depression, aggression, hostility), hepatotoxicity and male infertility.

There will be information of adverse outcomes in the “abuse and dependence” section and the “warnings and precautions” section will underscore the importance of measuring serum testosterone if there is any suspicion of abuse.