Group Petitions FDA to Add Black Box Warning to Low Testosterone Treatments, ClassAction.org Reports
The consumer advocacy group Public Citizen is petitioning the FDA to add black box warnings to the labels of all testosterone therapies, which would warn men of the risk of cardiovascular events associated with these products, ClassAction.org reports.
While the FDA’s January 2014 safety communication on testosterone products cited two recent studies that found a possible link between testosterone therapies and cardiovascular events, Public Citizen claimed that the FDA overlooked an important meta-analysis from April 2013. According to the result of that meta-analysis, there was a strong correlation between reported cardiovascular events in industry-funded studies and non-industry-funded studies. Researchers in the meta-analysis reviewed 27 trials on prescription testosterone performed during the last 20 years and found that 13 drug industry-funded trials showed no increase in cardiovascular events among men using prescription testosterone; however, 14 non-industry-funded trials “collectively showed a significant 2.06-fold increased risk with testosterone,” according to Public Citizen’s petition. Even including the industry-funded trials, the group pointed out that the overall conclusion of the meta-analysis still found that men were at an increased risk for cardiovascular events when using prescription testosterone.
While testosterone therapies are only FDA-approved for men who suffer from a related medical condition, a recent survey found that 25 percent of men prescribed testosterone replacement therapy did not have a blood test performed to determine whether they suffered from low levels of the hormone. The advocacy group warned that if the FDA did not add black box warnings to these treatments, “the continuing toll of heart attacks in people who are not even candidates for testosterone will continue.”
Recently, five men filed lawsuits against the maker of prescription testosterone gel AndroGel. These men allege that they suffered from heart attacks and strokes after using the product and that the manufacturer failed to adequately warn the public of these risks. If you or someone you know used a prescription testosterone therapy and suffered from a serious cardiovascular event, you may have legal recourse. For more information on your potential legal rights, visit http://www.classaction.org/tesosterone-therapy today.
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