Product News and Recalls

FDA Not Convinced about Testosterone Therapy Safety

fda not satisfied with testosterone therapy safetyThe U.S. Food and Drug Administration (FDA) recently informed “Low-T” drug manufacturers they will need to do a better job of demonstrating their products’ safety if they wish to market them to aging men. The agency’s argument was laid out by Christine P. Nguyen, a Deputy Director for Safety at the FDA, in an article in the New England Journal of Medicine.

Earlier this year, the FDA cracked down on testosterone therapy drug labels, requesting that companies like AbbVie (maker of AndroGel) and Eli Lilly (maker of Axiron) update their use and warning labels to indicate that testosterone is not approved for use in just anyone. According to the FDA, “testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland or brain that cause a condition called hypogonadism.” Testosterone is not approved for use in men experiencing the natural testosterone-lowering effects of aging. Yet according to the FDA, between 2009 and 2013, 30 percent of testosterone prescriptions were written without as much as a serum testosterone concentration test.

Now as before, the FDA is hesitant to let Low-T medications be marketed as “lifestyle” drugs. The agency’s concerns stem from mounting literature about dangerous side effects that may be caused by testosterone therapy. A study published in November 2013 found testosterone therapy to be associated with increased rates of heart attack, stroke, and death. Out of the 8,709 men observed, incidence of heart attack, stroke, and death was 29 percent higher in those who had received testosterone therapy. Another study in 2014 analyzed the risk of myocardial infarction (MI) in over 55 thousand testosterone therapy patients. It compared the rate of MI in the initial 90-day period after testosterone therapy was prescribed with the rate of MI in the year prior to treatment. The resulting pre-/post-prescription ratios of MI incidence were found to be 36 percent higher in all men and 119 percent higher in men aged 65 years or older.

These and other studies prompted the FDA to re-evaluate the health risks posed by testosterone products. In late January 2014, the agency issued a Drug Safety Communication warning of a potential link between testosterone products and cardiovascular problems. Later that year, the FDA released a statement that all testosterone therapy products on the market must include a warning about the general risk of venous blood clots.

Men who believe they were injured after receiving testosterone therapy have come forward and filed testosterone lawsuits. In June 2014, the U.S. Judicial Panel on Multidistrict Litigation consolidated testosterone lawsuits in federal court in the Northern District of Illinois. A little over a year later, this initial handful of cases has skyrocketed to include over 2,000 testosterone lawsuits — and that number is only expected to increase as the year progresses.