Testosterone products, e.g. AndroGel, Androderm, and Axiron, are under fire for their underreported propensity to cause heart attacks and strokes in individuals. Public Citizen announced yesterday that they have filed a petition to the U.S. Food and Drug Administration requesting that a black box warning immediately be added to testosterone products for their cardiovascular danger.
“Patients and consumers need to be made aware of the potential dangers associated with a product they may be taking or using,” commented Brandon Bogle, an attorney with the Levin, Papantonio law firm who practices in the areas of testosterone lawsuits, personal injury, and product liability litigation. “Time after time it comes to be known that manufacturers avoided disclosing risks that they were aware of with a product in order to get it to market and turn a profit. This puts consumers at risk unnecessarily.”
The “Black Box Warning” is commonly known to be the most serious warning issued by the FDA that a product can carry and still be available in the U.S. marketplace. The purpose of the warning is to make it abundantly clear to physicians and patients that the drug in question carries serious and potentially life-threatening risks.
Recent studies have found that men taking these products are at an increased risk for suffering from a cardiovascular event such as heart attack or stroke. Specifically, Public Citizen’s action was prompted by a recent study that involved 55,000 men who were monitored before and after starting testosterone use. The researchers found that, among men 65 and older, there was as much as double the risk of experiencing a cardiovascular event in the first three months of use when compared to the year prior. Additionally, men under 65 that had a preexisting heart condition were as much as 2.9 times more likely to experience a heart attack.
The FDA has stated that it “has not concluded that the FDA-approved testosterone treatment increases the risk of stroke, heart attack or death.”
Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group has stated, ‘In the face of this accumulating evidence, this statement [the FDA’s] is reckless and is a betrayal of the FDA’s role as an agency in the U.S. Public Health Service. It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks.”