February 25, 2014 — The consumer-advocacy group Public Citizen has petitioned the U.S. Food and Drug Administration (FDA) to add a Black Box warning label about the risk of heart attacks, blood clots, stroke, and other cardiovascular side effects from testosterone treatment gels, patches, injections, and other products.
Public Citizen called the FDA “reckless” and a “betrayal of its role in the U.S. Public Health Service” to state that it had not concluded that testosterone treatment increases the risk of blood clots, stroke, heart attack, or death.
In the FDA Safety Announcement, they stated that the first publication to prompt the FDA to asses cardiovascular side effects was an study published in November 2013 by JAMA. However, in 2010, a study had to be stopped prematurely because a significant number of older men on testosterone had cardiovascular events.
Public Citizen was also concerned about a meta-analysis of 27 smaller, randomized trials. Notably, the 13 drug-industry funded trials collectively failed to find any increase in cardiovascular events from testosterone, but the 14 non-industry-funded trials showed a 2.06-fold increased risk.
Dr. Sidney Wolfe, founder and senior advisor of Public Citizen’s Health Research Group, warned:
“Unless the FDA immediately begins to provide strong, adequate black-boxed warnings about the risks of heart attacks and other cardiovascular diseases, the continuing toll of heart attacks, many in people who are not even candidates for testosterone, will continue.”
In addition, the petition urges the FDA to delay its decision on approving Aveed, a long-acting testosterone injection manufactured by Endo Pharmaceuticals, which will be reviewed on February 28.
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