FDA Requires Revised Labeling for Testosterone Drugs to Warn of Increased Risk of Blood Clots
On June 20th, the U.S. Food and Drug Administration (FDA) issued a safety warning notifying health care professionals and medical care organizations that it will require manufacturers of approved testosterone products to revise their product labeling to include heightened warnings about the risk of venous blood clots.
The previous labeling included the risk of blood clots in the veins as a result of polycythemia, which is an abnormal increase in the number of red blood cells. However, there have been recent post-marketing reports of venous blood clots unrelated to polycythemia, such as deep vein thrombosis (DVT) and pulmonary embolisms (PE). These adverse events have prompted the FDA to require a more general warning in the product labeling so that this risk is consistently identified in the labeling of all approved testosterone products.
The FDA is currently evaluating potential risks of certain cardiovascular events, such as stroke, heart attack, and death, in patients using testosterone treatments. Testosterone products are approved for men who lack or have low testosterone levels in connection with an associated medical condition, which can be caused by genetic problems or chemotherapy.
If you or a loved one has suffered injuries after using testosterone products, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.
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