The Food and Drug Administration (FDA) is investigating possible increased risks of stroke, heart attack and death in men using testosterone replacement therapies. This move follows recent studies that raised red flags. The FDA launched the inquiry after the recent publication of two research articles that found elevated cardiovascular risks in men using testosterone replacement products. The agency said it has not reached any conclusions about possible dangers.
One study, published in November in the Journal of the American Medical Association, described a 30 percent rise in such risks in a comparison of thousands of patients. In that analysis, 26 percent of men using testosterone products died, had a heart attack or suffered a stroke. By contrast, 20 percent of men not using the products experienced those outcomes. A second study, published in January of this year in the journal PLOS ONE, found that risks of heart attack doubled in men older than 65 who were using testosterone replacement. The FDA said:
We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.
The FDA’s inquiry has major implications for treatments that address low testosterone levels, notably AndroGel, a blockbuster topical treatment from AbbVie Inc. The most serious risks of that product, according to its current labels, are a possible propensity for prostate cancer, sleep apnea and swelling and blood clots in the legs. Officials at AbbVie reported recently that AndroGel had slightly more than $1 billion in U.S. sales during 2013.
FDA officials provided no timetable for completing their investigation. In the meantime, the agency said that patients should talk with their doctors before halting therapy, and physicians should weigh benefits against possible risks in deciding whether to continue or begin treatment. Testosterone replacement is only FDA-approved in men with both “Low T” and an associated medical condition, such as a genetic inability to produce the hormone or brain disorders that inhibit production. It’s often marketed as an age-defying therapy that may help boost sex drive, increase muscle mass and strengthen bones, among other things.
Lawyers in our firm’s Mass Torts Section are handling the testosterone cases. If you need more information on this litigation or the subject generally, contact Matt Teague, a lawyer in the Section, at 800-898-2034 or by email at Matt.Teague@beasleyallen.com.
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