Another Testosterone Warning – This Time For Abuse
Action follows agency review of 81 adverse events reported with testosterone/anabolic androgenic steroid misuse, abuse, or dependence over 45 years; discussions continue on cardiovascular study.
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US FDA advisory committee worries about off-label use of Lipocine's Tlando and Clarus' Jatenzo.
FDA proposal obtained by “The Pink Sheet” DAILY eliminates language describing symptoms of low testosterone.
Labeling updates will also clarify approved uses and warn of possible increased risk of heart attack and stroke; impact on products in development unclear.