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FDA Requires Testosterone Products to Include General Warning About Blood Clots

In late January, the U.S. Food and Drug Administration (FDA) issued a safety announcement stating that the agency would begin investigating adverse heart risks associated with testosterone products, including Low T drugs such as AndroGel® and Axiron®. The warning was issued after several studies found that men taking Low T drugs faced significantly increased risks of heart attack, stroke, and death. Just this month, the FDA announced that it is requiring all testosterone products to include a general warning about risks of venous thromboembolism, or blood clots in veins.

Officials from the FDA, stated that the announcement came after it received a number of adverse reports from men taking Low T drugs. Currently, testosterone products contain warnings about blood clots related to a condition known as polycythemia. However, the latest reports from injured patients relate to a different blood clot condition.

The new warning serves as further evidence about the dangerous side effects of testosterone drugs, which have become incredibly popular among U.S. men as a treatment for low testosterone. The FDA says that the new warning is unrelated to the current investigation on risks of heart attack, stroke, and death.

The Senators (Ret.) Firm, LLP is continuing to investigate claims from men who have suffered harm after using testosterone drugs, including side effects such as stroke, heart attack, and blood clots. If you or someone you love has been injured after using Low T drugs, our product liability attorneys are prepared to evaluate your case to determine if you may have a claim.

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