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Activists Urge FDA to Add Black Box on Testosterone Products


February 25, 2014 — Public Citizen, a consumer watchdog group based in Washington D.C., has submitted a petition calling on the Food and Drug Administration (FDA) to add a boxed warning about cardiovascular risks to the label on all testosterone replacement products.

The FDA published a Safety Announcement in January 2014, announcing an investigation but stopping short of concluding that testosterone could increase the risk of blood clots, stroke, and death.

Public Citizen called the FDA action “reckless” and a “betrayal of its role in the U.S. Public Health Service.” The announcement omitted risk information from a 2010 study published in the New England Journal of Medicine that had to be halted after men on testosterone had significantly more cardiovascular events.

In addition, Public Citizen cited evidence from a meta-analysis of 27 smaller clinical trials. Interestingly, 13 trials funded by the drug industry failed to link testosterone and cardiovascular events, while 14 non-industry funded studies found a doubled increased risk.

These findings were confirmed in a study of over 55,000 men that was published in PLOS One in January 2014, which linked testosterone treatment in men over 65 to a doubled risk of heart attacks.

According to Dr. Sidney Wolfe, senior advisor and founder of Public Citizen’s Health Research Group:

“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.”

Dr. Wolfe also called on the FDA to delay making a decision on the approval of Abveed, a new long-acting testosterone injection that is up for review on February 28. Without a boxed warning about cardiovascular risks, the new product could exacerbate a serious public health problem.


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