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FDA Issues New Testosterone Replacement Warning

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FDA Requires Testosterone Replacement Manufacturers to Warn About the Risk of Blood Clots

On Thursday, June 19, 2014, the Food and Drug Administration issued yet another public warning about the dangers of testosterone replacement products.  In this latest warning, the FDA announced that it is requiring manufacturers of testosterone products to include a general warning in the product labeling about the risk of blood clots in veins.  The FDA’s recent action is due to “postmarket reports of venous blood clots” in those taking testosterone products. 

This latest warning follows an FDA Drug Safety Communication posted on January 31, 2014, in which the agency announced that it was evaluating the risk of stroke, heart attack, and death associated with testosterone replacement products.  The FDA was clear to point out that its latest warning is “not related to FDA’s ongoing evaluation of the possible risk of stroke, attack, and death in patients taking testosterone products,” but is instead a separate warning. 

Lawsuits against testosterone replacement manufacturers were recently consolidated in a multidistrict litigation (MDL) proceeding in the U.S. District Court for the Northern District of Illinois.  These lawsuits allege that the testosterone replacement products are defective and the cause of injury to the plaintiffs.  The lawsuits have been filed after a number of scientific studies concluded that medical complications can arise from the use of testosterone replacement products.  The specific products at issue include AndroGel, Axiron, Androderm, and Testim, among others.

The testosterone therapy lawsuit attorneys at Ashcraft & Gerel continue to investigate possible lawsuits against the makers of testosterone products.  If you feel that you or someone you know should be compensated for harm caused by a testosterone replacement product, please contact us online or call us at 800-829-7037 to speak with an attorney today.  

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