June 19, 2014: FDA Requires Testosterone Labeling To Include Testosterone Blood Clot Risk Warning

FDA Mandated Testosterone Blood Clot Risk Labeling – The U.S Food and Drug Administration (FDA) will require manufacturers of all approved testosterone products to include a warning regarding the risk of venous blood clots with testosterone use in the product labeling.

Testosterone labeling currently includes the risk of venous blood clots as a possible consequence of a medical condition known as polycythemia (an abnormal increase in a person’s red blood cell count). The FDA stated that because it has received reports of venous blood clots unrelated to polycythemia, the agency will now require testosterone product labeling to carry a broader warning regarding testosterone blood clot risks.

Blood Clots – Deep Vein Thrombosis (DVT) Can Result In Life Threatenting Pulmonary Embolism (PE)

Blood clots forming in the deep veins are referred to as a deep vein thrombosis (DVT). If a DVT breaks free (often from the deep veins of the legs ) and travels to the lungs, it can cause a sudden blockage in a lung artery called a pulmonary embolism (PE). Because a PE can block the flow of blood to the lungs, it can be disabling or fatal.

The new testosterone blood clot risk warning is not related to the FDA’s ongoing evaluation of the potential risk for heart attack, stroke and death in patients using testosterone products. Heart attack, stroke, and death are cadiovascular events related to blood clots in the arteries, and are described in the FDA Drug Safety Communication posted on January 31, 2014. FDA asks health care professionals and consumers to report any testosterone adverse drug reactions to MedWatch.

Contact Weinberg Law Firm For A Free Testosterone Blood Clot Lawsuit Or Testosterone Pulmonary Embolism Lawsuit Evaluation

Since 1984, Attorney Eric Weinberg has represented personal injury and product liability victims, including those injured by pharmaceutical drug products, obtaining over $800 million in recoveries on behalf of clients. If you or a loved one has suffered injuries related to the use of testosterone, including blood clots, pulmonary embolism, heart attack, stroke, or death you may be entitled to financial compensation. For a free and non-obligatory testosterone lawsuit evaluation, please call the personal injury lawyers at The Weinberg Law Firm 24/7, toll free at 1-877-934-6274.


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