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FDA Requests Broader Warning for Blood Clots On Testosterone Products

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On June 20, 2014 the U.S. Food and Drug Administration made a statement that all testosterone products on the market need to include a general warning about the risk of blood clots in veins on their warning labels.

Although testosterone products already carry a warning about the risk of clots related to polycythemia, a condition that sometimes happens with testosterone treatment. Polycythemia is an abnormal increase in the number of red blood cells that can lead to blood clots. Testosterone products are also the focus of an FDA investigation into the risk of stroke, heart attack, and death in men taking such medications.

In its latest report, the FDA said that after receiving reports of blood clots in the veins unrelated to polycythemia in patients taking testosterone products, it decided to require a more general warning on the labeling. Blood clots in the veins include deep vein thrombosis, or DVT clots typically found in the legs, and pulmonary embolism, a potentially deadly event that occurs when a clot breaks away and travels to the lungs. The FDA also advised doctors to consider whether the benefits of testosterone treatment outweigh the potential risks.

Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are approved for use in men who lack or have low levels of testosterone (low-T) in combination with an associated medical condition. These medical conditions include failure of the testicles to produce testosterone because of genetic problems or chemotherapy. Approved formulations include topical gel, transdermal patches, buccal system, and injection.

Symptoms of low-T include:

Products affected by the FDA request include AbbVie Inc’s AndroGel, Endo International Plc’s Aveed and Trimel Pharmaceuticals Corp’s Natesto. AndroGel, a testosterone gel applied to the shoulder and upper arm, and Axiron, a solution applied to the underarm, are two of the most commonly prescribed and heavily marketed testosterone products. For example, sources say that AbbVie spent $80 million on marketing AndroGel in 2012 alone.

If you or a loved one has suffered cardiac complications or blood clot injuries as a result of taking testosterone therapy, consult with one of our Georgia Testosterone Supplement Lawyers to explore your legal rights. Our attorneys are committed to holding these drug manufacturers accountable. Contact us today for a free consultation.

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