Consumer Advocacy Group Calls for FDA to Add Warnings on Testosterone Drugs

Medical professionals and safety advocates across the country have been closely following developments in the world of testosterone drugs. In the past several months, a series of studies have associated testosterone therapy in men with increased risks of cardiovascular problems – including blood clots, stroke, and heart attack.

For many of these outspoken advocates, a large part of the problem, and perhaps the most concerning problem, is that testosterone drugs have become widely used by American men. The popularity of testosterone has skyrocketed in recent years, nearly quadrupling from 2001 to 2011. This meant not only that doctors were freely prescribing testosterone products to men who did not have a serious medical need, but also that these millions of men believed that these products were safe for their intended use. If one consumer advocacy group has its way, consumers will be well informed about the risks associated with testosterone.

A Push for Warning Labels

Public Citizen – a national, well-renowned consumer advocacy group – is calling for the U.S. Food & Drug Administration (FDA) to add bold warning labels to FDA-approved testosterone drugs. This call is a direct response to the several studies that have found testosterone significantly increases heart risks in older men and men with known heart disease. Public Citizen is requesting a “black box” warning, the most serious warning administered by the FDA. Manufacturers should also be required to warn physicians about associated risks, according to the group.

Although the FDA has recently announced that it would be conducting further research into testosterone risks, Public Citizen claims that studies dating back to 2010 should have prompted earlier concerns. Currently, most testosterone products are labeled to indicate only that testosterone drugs should be taken by men with abnormally low testosterone. The aggressive marketing tactics of pharmaceutical companies, however, resulted in a much broader pool of men taking testosterone therapy, even those who never had their testosterone levels checked.

Injured after using testosterone? Learn more about your rights!

While the FDA debates over whether or not to add warning labels to testosterone products, consumers who have already suffered injuries after using testosterone may be eligible to pursue a recovery of their damages through legal means. At The Senators (Ret.) Firm, our testosterone injury lawyers are currently evaluating cases of men who experienced cardiovascular problems such as heart attacks after using testosterone.

For more information about your right to file a testosterone lawsuit, call (949) 557-5800 or complete a FREE confidential case evaluation form on this website.