The FDA Should Require Warnings on Testosterone Products, Public Citizen Tells FDA Advisory Committees

Sept. 17, 2014         

The FDA Should Require Warnings on Testosterone Products, Public Citizen Tells FDA Advisory Committees

Products Are Associated With Heart Attacks and Other Cardiovascular Risks

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should require that the product labels of all testosterone-containing medications available in the U.S. be revised to include warnings about the increased risk of heart attacks and other life-threatening cardiovascular dangers, Public Citizen told the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee, and Drug Safety and Risk Management Advisory Committee in testimony today.

More than five million U.S. prescriptions for testosterone products were filled in 2013. The most common of those, making up more than 90 percent of the testosterone prescriptions filled in 2013, include Androgel, Axiron, Testim and Fortesta. In its testimony, Public Citizen highlighted the compelling evidence linking testosterone therapy to increased risks of heart attacks and other cardiovascular dangers.

Public Citizen petitioned the FDA on Feb. 25 to immediately add a black box warning about these risks to the product labels of all testosterone products marketed in the U.S., but the agency denied the petition on July 16. Remarkably, in its denial letter, the FDA stated that it was still assessing the potential cardiovascular risks of these products.

Although the FDA agrees that testosterone is “only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition,” the hyped-up nature of the low-T[estosterone] advertising campaigns, not adequately regulated by the FDA, assures that many men in the U.S. who are prescribed testosterone do not meet the FDA-specified criteria of both low testosterone levels and an associated medical condition due to hypogonadism. Evidence can be seen in the recent finding that almost 25 percent of men prescribed testosterone in this country had not previously had a blood test to even determine if their testosterone level was low.

On July 15, Health Canada, the agency in Canada that regulates prescription medications, issued a safety alert to patients and health care providers about the cardiovascular risks associated with testosterone therapy. The Canadian agency “found a growing body of evidence (from published scientific literature and case reports received by Health Canada and foreign regulators) 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 reported that it was working with manufacturers to update Canadian product labels regarding these risks. Health Canada’s actions are based on the same evidence available to the FDA.

“The action taken by Health Canada to protect public health stands in stark contrast to the FDA’s reckless inaction,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “As in Canada, health care providers and patients in the U.S. need to be warned about the risk of heart attacks and other serious adverse cardiovascular effects associated with testosterone products, which are widely overprescribed in the U.S. to men for whom they are not indicated.”

In its testimony, Public Citizen urged the advisory committees to recommend that the FDA immediately require such warnings on the labels of all testosterone products.

Read Public Citizen’s testimony.