Amendments were made to the prescribing information for testosterone-containing products, to warn about the risk of serious adverse cardiovascular and mental complications, related to the substance overdose.
Until recently testosterone-containing Rx drugs were used as hormonal replacement therapy for treatment of low level testosterone in men. Besides, steroids with high doses of testosterone are frequently used, at times uncontrolled, by athletes and bodybuilders. Practical evidence has shown that such use of testosterone, and other anabolic-androgenic steroids is dangerous to health. It causes addiction and involves withdrawal syndrome, depression, chronic fatigue, dehydration, loss of appetite, decreased libido and insomnia. That is why FDA considers it necessary to provide an additional warning on the risks of testosterone-containing drugs.
Now informational leaflets for patients will contain risks related to abuse of testosterone-containing drugs.