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.
READ MORE TESTOSTERONE TREATMENT LEGAL NEWS
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.