Public Citizen petitions FDA for serious "black box" warnings on testosterone replacement drugs

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A national consumer advocacy organization this week urged the U.S. Food and Drug Administration to require pharmaceutical companies to add bold warning labels to their popular testosterone replacement therapies.

Public Citizen called on regulators to require so-called “black box” warnings—the most serious of warnings—on all Low T therapies because recent studies have shown they double the risk of heart attacks, strokes and even death in older men who take them.

The consumer group’s push comes on the heels of the FDA’s announcement in January that it was reviewing the safety of AndroGel, AndroDerm and other testosterone replacement therapies.

In requesting the warnings, Dr. Sidney Wolfe, of Public Citizen’s health group, said “it is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks.”

Wolfe also urged the FDA to delay its approval of a new, long-acting testosterone injection called Aveed scheduled for later this week.

Ross Feller Casey, a Philadelphia personal injury firm with a national reputation for winning record results, is evaluating lawsuits against the makers of testosterone replacement drugs. If you or a loved one has suffered severe cardiovascular problems while on or shortly after using these drugs, please contact one of our testosterone lawyers immediately for a free case evaluation.

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