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Home » FDA Issues New Safety Warning for Testosterone Products

FDA Issues New Safety Warning for Testosterone Products

The FDA issued a new safety warning on Friday June 20, 2014 based on a number of reports of venous blood clots, also known as deep vein thrombosis (DVT), pulmonary embolism (PE), and venous thromboembolism (VTE). Earlier this year, the FDA announced it would be conducting an investigation into testosterone replacement therapy drugs for an increased risk in heart attack, stroke, and blood clots such as DVT and PE. The agency has not completed its investigation and this safety warning is considered to be separate from any findings from the investigation.

The market for testosterone replacement therapy has been growing aggressively since 2001 when drug makers coined the term “Low T”, or low testosterone, and urged men who were overweight, tired and/or less interested in sex to consider testosterone replacement.

A study published in the Journal of the American Medical Association and a study published in the Public Library of Science Online indicate that men who take prescription testosterone products had as much as a 30% increased risk for heart attack and stroke after using the drugs. These studies prompted the FDA to investigate further into these “Low T” drugs.

Lawsuits have been filed against makers of prescription testosterone products. Many men claim to have suffered serious injuries such as heart attacks, strokes, and serious blood clots like deep vein thrombosis and pulmonary embolisms after taking prescription testosterone drugs.

If you or someone you know has suffered a prescription testosterone injury, contact us. Our product liability attorneys have talked with hundreds of men who have taken drugs like Axiron, AndroGel, Androderm and others. Contact us now for a free case evaluation.

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