FDA: Testosterone products must warn about clot risk

June 21, 2014 4:05 PM

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The U.S. Food and Drug Administration (FDA) is now requiring testosterone products to have labels with a general warning that they can cause venous thromboembolism, reports MedPage Today. Product labels will be required to carry a general warning about the risk of blood clots in the veins. Additionally, they should also carry a warning about those events as a possible consequence of polycythemia that is already included in the product information.

This change in labeling requirements comes as the result of an ongoing investigation by the FDA, evaluating the risk of stroke, heart attacks, and death due to use of FDA-approved testosterone products. The FDA is reevaluating because recent studies suggested an increased risk of cardiovascular even...

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