FDA requires new warning label on testosterone

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Jinzang

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This was in the news this morning:

The new labels for all prescription testosterone products include a new warning and an updated Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS).

The label changes announced on Tuesday by the US Food and Drug Administration (FDA) follows the placement of AAS, including testosterone, in Schedule III of the Controlled Substances Act thanks to the Anabolic Steroids Control Act of 1990.


“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,” FDA said.
 
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