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June 19, 2014: FDA Requires Testosterone Manufacturers To Warn Of Testosterone Blood Clot Risks

Testosterone Blood Clot Risks – The U.S Food and Drug Administration (FDA) has notified healthcare professionals that the manufacturers of all approved testosterone products will be required to include a warning in their product labeling regarding the risk of venous blood clots with testosterone use.

FDA Requires Testosterone Blood Clot Warning Due To Post Market Reports

Testosterone product labeling currently includes the risk of venous blood clots as a possible consequence of polycythemia (an abnormal increase in a person’s red blood cell count). However, because the FDA has received reports of venous blood clots unrelated to polycythemia, the agency will require all manufacturers to include a broader warning regarding testosterone blood clot risks in their product labeling.

Deep Vein Thrombosis (DVT) Can Cause A Pulmonary Embolism (PE)

Blood clots forming in the deep veins are referred to as a deep vein thrombosis (DVT). If a DVT breaks free (usually from a lower limb) 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. See blood clots and pulmonary embolism for more information regarding this serious medical condition.

FDA Continues To Evaluate Risk Of Stroke, Heart Attack And Death Related To Testosterone Use

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

Obtain a Free Testosterone Blood Clot and Pulmonary Embolism Lawsuit Evaluation

Since 1984, Attorney Eric Weinberg has represented personal injury victims, including those injured by dangerous pharmaceutical products such as Baycol, Vioxx, OrthoEvra, Yaz, Vaginal Mesh, Pradaxa, and blood clotting products. We are ready to help you. 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 Weinberg Law Firm 24/7, toll free at 1-877-934-6274.

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