FDA Investigating the Risk of Cardiovascular Events in Men Using Prescription Testosterone Products
The FDA announced that it would be reassessing the safety of prescription testosterone after two separate studies linked the treatments to serious cardiovascular events including stroke, heart attack and death.
On January 31, 2014, the FDA published a safety announcement to alert the public that it would be investigating the risk of heart attack, stroke and death in men using prescription testosterone products. The investigation was spurred by two recent studies, published in the medical journal PLOS ONE and The Journal of the American Medical Association (JAMA), which both found a link between prescription testosterone and serious cardiovascular events. Researchers in the JAMA study found that men using prescription testosterone therapies were at a 30 percent increased risk of heart attack, stroke and death. Furthermore, the PLOS ONE study shed some light on groups of men who may be at the highest risk for serious cardiovascular events: middle-aged men with a history of heart disease and men ages 65 and older. According to the study, these men were tracked for a year prior to receiving prescription testosterone and the three months following testosterone therapy. Researchers found that the men suffered from twice as many heart attacks and ischemic strokes after using prescriptions to treat low testosterone.
In its safety announcement, the FDA stressed that prescription testosterone therapies have only been approved for use in men with a medical condition that affects their levels of testosterone, including certain genetic problems. The agency suggested that healthcare professionals consider whether the benefits of prescription testosterone outweigh its risks and advised that men using prescription testosterone therapies should not stop using the treatments before speaking with their doctors. While the agency said it has not reached any conclusions yet, it is continuing to review available data on the risks of prescription testosterone.
Following the FDA’s announcement, several lawsuits were filed against the maker of the prescription testosterone product AndroGel. These lawsuits allege that men who used AndroGel suffered heart attacks, strokes or ischemic strokes, and that Abbott Laboratories failed to adequately warn physicians and patients that its testosterone product could cause serious cardiovascular events. In light of these allegations, the attorneys working with ClassAction.org are looking to hear from men who used prescription testosterone therapies. If you or a loved one suffered an injury after using prescription testosterone, contact us today by visiting http://www.classaction.org/testosterone-therapy.
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