FDA Adding General Warning About Venous Blood Clotting to Testosterone Products

The FDA announced that it is requiring a general warning in the drug labeling for all approved testosterone products about the potential risk of venous thromboembolism (VTE), or blood clots in the veins, which include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the drug labeling for testosterone products as a potential consequence of polycythemia, an increase in the number of red-blood cells that occasionally occurs with testosterone treatment. However, postmarket reports of blood clots unrelated to polycythemia have led the FDA to require a broader warning in the drug labeling to assure that the risk is consistently described for all testosterone products.

This new warning of venous blood clots comes after the FDA announced months ago that it would be investigating potential risk of heart attack, stroke, and death in patients using testosterone products. These risks are associated with blood clots in the arteries, and the evaluation is ongoing.

If you or a loved one has suffered an injury after using testosterone replacement therapy, contact Morelli Law Firm immediately to learn more about your rights. Call 888-396-4930 or fill out a FREE consultation form.

Categories: Testosterone Lawsuit
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