Prescription Testosterone Products Get New FDA Health Warnings

Santa Clara, CAAll prescription testosterone products will now carry class-wide labeling changes introduced by The U.S. Food and Drug Administration (FDA) to warn of the health risks associated with testosterone abuse and dependence.
The revised safety information is taken from published literature and case reports regarding the abuse and dependence of testosterone and other anabolic-androgenic steroids, or AAS.

Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders.
Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia.

The FDA said in a statement that the new warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS abuse.

Prescription testosterone products are FDA-approved as hormone replacement therapy for men who have low testosterone due to certain medical conditions. Examples of these conditions include failure of the testicles to produce testosterone because of genetic problems, or damage to the testicles from chemotherapy or infection.

One testosterone drug, Androgel, warns on its label a number of testosterone side effects including high blood pressure, blood clots in the legs and serious problems for people who have heart, kidney or liver disease. Other low-t treatment brand names include Androderm, Axirom, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim and Testope. Men who have suffered such side effects are filing testosterone lawsuits.