In light of mounting evidence that the hormone treatments raise the risk of heart attacks, the consumer advocacy group, Public Citizen, is urging the Food and Drug Administration to add a bold warning label to testosterone products.
Public Citizen wants the FDA to immediately add a “black box” warning to all such products. A “black box” warning is the most serious warning the FDA can add to a drug label. The group also wants manufacturers to warn doctors of the elevated risk of heart attack, stroke and death from use of the products.
Last month, the FDA announced that it was reviewing the safety of testosterone treatments based on two recent studies that indicated increased cardiovascular problems in men using the supplements. The FDA reported that its safety review was first prompted by a study by the U.S. Veterans Affairs published in 2013 that disclosed a 30 percent increase in heart attack, stroke and death in older men using supplements. Then, in January 2014, a federally funded study of 45,000 men indicated testosterone therapy could double the risk of heart attacks in men aged 65 and older.
Public Citizen reports that studies as early as 2010 should have alerted the FDA and prompted action.
Dr. Sidney Wolfe, of Public Citizen’s health group, stated “It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks.”
In addition to the black box warning, Public Citizen urged the FDA to postpone an approval decision on Aveed, an experimental, long-acting injection. The FDA is currently scheduled to make its decision on the drug by February 28th. Aveed is a product of Endo Pharmaceuticals.
Prescriptions for hormone products in the United States have increased more than five-fold in recent years, leading to over $1.6 billion in sales annually.
Although FDA labeling indicates the products are to be used only in men with a medical condition that causes abnormally low testosterone, pharmaceutical companies have launched advertising campaigns targeting otherwise healthy men with “low T”. Pharmaceutical companies claim hormone therapy can reduce or reverse side effects of aging, including insomnia and erectile dysfunction.
Testosterone products include Abbvie’s Androgel, which is applied to the shoulders and arms; the Androderm patch, manufactured by Watson Pharmaceuticals, which slowly releases the drug into the bloodstream; Axiron, an Eli Lilly underarm gel that rolls on like deodorant and Fortesta, a gel marketed by Endo Pharmaceuticals.
The Columbus Ohio testosterone injury lawyers at Clark, Perdue & List are available for consultation for men who may have suffered cardiovascular injury as the result of the use of these products.