Prescription testosterone treatments are getting new warning labels to inform patients that drugs like AndroGel may increase their risk of experiencing a heart attack or stroke. According to a Drug Safety Communication issued by the U.S. Food & Drug Administration (FDA), the agency has also mandated that the medications’ labels clearly state that they are only approved for men whose low testosterone levels are caused by certain medical conditions, not by the normal aging process.
Among other things, the March 3rd communication notes that the FDA “had become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”
According to the FDA, about 1.3 million men were being treated with prescription testosterone therapy medications such as AndroGel, Testim and Axiron in 2013, about double the number of men who were prescribed the drugs in 2010. Of those, only about 25% had undergone blood tests to determine whether or not they actually suffered from low levels of the hormone.
A growing number of critics, including plaintiffs in testosterone lawsuits, have charged this uptick is the result of aggressive direct-to-consumer advertising campaigns that have induced many men to seek out testosterone treatment to remedy low libido, fatigue, loss of muscle mass, and other issues associated with male aging.
The FDA began investigating the cardiovascular risks potentially associated with low testosterone therapy in January 2014, after a pair of studies found that the drugs might increase the risk of heart attack, stroke and death in men with pre-existing heart disease, as well as older men. In yesterday’s communication, the FDA also announced that it was requiring the manufacturers of low T therapies to conduct a “well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products.” The drug companies have the option of working together on a single study, or they can conduct their own separate trials.
Since the FDA announced its safety review in January 2014, more than 1,000 testosterone lawsuits have been filed in federal court on behalf of men who allegedly suffered heart attacks, strokes, and other serious cardiovascular problems due to their use of AndroGel and similar drugs. In addition to raising questions about the marketing tactics used to drive sales of the medications, the lawsuits accuse their manufacturers of concealing the heart risks associated with testosterone replacement drugs.