FDA Convenes Advisory Panel Meeting on Testosterone Side Effects

Washington, DCConcerns about the risk of testosterone side effects have prompted the US Food and Drug Administration (FDA) to call a meeting for its advisory committee to discuss the possibility of testosterone-related cardiovascular events. The move comes shortly after the FDA updated the warnings for testosterone drugs to alert patients to the risks associated with the medications. Testosterone lawsuits have been filed against drug companies alleging patients were not properly warned about the risk of side effects.

The FDA announced a Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, to be held September 17 and 18 in Maryland. The purpose of the meeting is to “discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use,” according to the FDA.

The meeting announcement came shortly after a June announcement from the FDA that the agency was requiring manufacturers of approved testosterone products to include a general warning about the risk of blood clots in the veins. Although testosterone product labels already include a warning about blood clots in the veins, that warning relates to blood clots as a consequence of polycythemia. The new warning comes after reports that blood clots have developed unrelated to polycythemia.

Although the FDA has asked for an updated general warning, it rejected adding a Black Box warning - the strongest warning possible - to the warning label of testosterone drugs.

In January 2014, the FDA announced that it was investigating the risk of stroke, heart attack and death in men taking testosterone products. The agency reported, however, that it had not concluded that testosterone increases the risk of heart attack, stroke and/or death.

The January safety announcement was issued after two studies suggested an increased risk of cardiovascular events in groups of men who used testosterone therapy. One study found double the risk of heart attack among men aged 65 and older in the first 90 days following the start of treatment. Men younger than 65 reportedly showed two to three times the risk of heart attack in the first 90 days following the start of treatment.

Testosterone therapy is used by men who have low levels of testosterone that occur along with associated medical conditions. The therapy is not approved for men who have low testosterone but lack associated medical conditions.

Meanwhile, Health Canada, Canada’s version of the FDA, has also issued a warning that cardiovascular problems may be linked to the use of testosterone. The agency noted that it had completed a safety review of testosterone replacement products and found evidence “for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate with the use of testosterone replacement products.”

Health Canada said that it is working with manufacturers to update the Canadian product labels to alert patients about the risk.

Lawsuits have been filed against the makers of testosterone therapies, alleging patients were harmed by the use of testosterone and that they were not adequately warned about the risks involved with the therapy.