FDA Advisory Panel to Consider Risks and Benefits of Testosterone Replacement Drugs

testosterone_therapyA Food and Drug Administration document says there is little evidence that testosterone drugs taken by millions of American men are beneficial.

The FDA posted the review online Wednesday in advance of a September 17 advisory committee meeting to discuss the benefits and risks of testosterone treatments. The scrutiny comes amid recent heavy marketing for testosterone pills, patches, and gels, BND.com reports. Ads for prescription products including Fortesta and Androgel promise relief from “low T,” which the ads link to low libido, fatigue and weight gain. But the FDA says “the need to replace testosterone in these older men remains debatable.” Testosterone levels naturally decline after age 40, but it is not clear whether lower levels actually lead to decreased energy and loss of muscle.

Testosterone injections were first approved in the 1950s for men diagnosed with hypogonadism, abnormally low testosterone caused by injury or illness. But current advertising focuses on otherwise healthy men who simply have lower levels of testosterone. The FDA briefing document says there are no “reliable data on the benefit” of testosterone treatment in this population. About 2.3 million men received a prescription for testosterone last year, the FDA reports. According to the agency, for more than 20 percent of these patients there is no record that their testosterone levels were measured.

At the September 17 meeting, a panel of outside experts will consider whether prescribing information for testosterone drugs should focus on a narrower group of patients. They will also consider two recent studies on cardiovascular problems in men using testosterone. A 2013 Veterans Affairs study showed a 30 percent increase in stroke, heart attack and death among older men taking testosterone. A 2014 federally funded study of 45,000 men with an existing heart condition suggested testosterone therapy could double the risk of heart attacks in men 65 and older.

Dr. Sidney Wolfe, of the consumer advocacy group Public Citizen, said he expects a warning about heart risks to be added to testosterone drug labels, according to BND.com, and “once it happens the prescribing will drop way down, and that will be to the betterment of the public health.”



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