In recent months, the results of multiple studies of testosterone medications have shown that these drugs are associated with an increased risk of cardiovascular diseases, including heart attack and stroke.
In February 2014, the consumer advocacy group Public Citizen petitioned the Food and Drug Administration to add a “black box” warning to the labels for testosterone drugs, which are widely prescribed to men for a catchall condition referred to as low testosterone, or “low T”. The request comes on the heels of mounting evidence that these medications are linked to an increased risk of heart attack.
Public Citizen has requested that the FDA immediately strengthen the labels for all testosterone medications—including the addition of a bolded “black box” warning—and that the agency require manufacturers to warn prescribing doctors about the increased risks of heart attack, stroke and death.
In January 2014, in response to recent studies showing higher rates of cardiovascular problems, the FDA reported that it was reviewing the safety of drugs like the popular testosterone gel, AndroGel. The agency’s action was prompted by a U.S. Veterans Affairs study, published in November 2013, which demonstrated a 30 percent increase in stroke, heart attack and death among older men taking testosterone. A similar finding was reported in January 2014, based on the results of a federally funded study of 45,000 men, which showed that testosterone therapy could double the risk of heart attacks in men 65 and older.
According to Public Citizen, these data are not new. Indeed, studies published as early as 2010 indicated a significant cardiovascular risk. “It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks,” said Dr. Sidney Wolfe, the founder and director of the advocacy group.
The Public Citizen petition is supported by an analysis of 27 testosterone trials, published in April 2013. The researchers reported that while 13 studies funded by drug companies did not show an increase in heart problems, 14 non-industry funded trials showed a two-fold increase in the risk of heart problems.
Public Citizen has also advocated for the FDA to delay an approval decision on an experimental, long-acting testosterone injection called Aveed. The agency is scheduled to make a decision on the Endo Pharmaceuticals drug by Feb. 28.
Panish, Shea & Boyle is investigating cases involving heart attack or stroke in patients using testosterone medications such as: