FDA Panel Calls for Tighter Restrictions on Testosterone Therapy

(HealthDay News) — There is little evidence that testosterone replacement therapy effectively treats normally declining levels of the hormone in aging American males, said the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee during a joint meeting.  

The panel overwhelmingly voted 20-1 to tighten use of the popular drugs and require drug makers to conduct tests assessing the drugs’ risk for heart attack and stroke, according to Bloomberg News

The FDA is not required to follow the recommendations of its expert panels, but it usually does.

The FDA review pointed out that there’s no clear scientific evidence showing testosterone replacement can reverse some of the effects of aging. It also noted that there’s growing evidence many men who are receiving testosterone replacement therapy do not need it. 

An FDA analysis found that only about one-half of men now taking testosterone therapy have been diagnosed with hypogonadism, the specific medical diagnosis for testosterone deficiency. 

Further, 25% of men started the therapy without lab testing to confirm that they had low levels of testosterone. More than one in four never received a lab test during the course of their therapy.

In June, the FDA announced that testosterone supplement products must now carry a warning label on the general risk of venous thromboembolism.