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FDA Evaluating Risk of Stroke, Heart Attack and Death with AndroGel

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The U.S. Food and Drug Administration (FDA) recently announced that it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products, including AndroGel.

The FDA has been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.

Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.

None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection..

The FDA urges health care professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1

The experienced AndroGel attorneys at Schachter, Hendy & Johnson, P.S.C. have filed multiple AndroGel lawsuits where men suffered strokes, pulmonary embolisms and blood clots while using AndroGel. If you or a loved one have suffered a stroke, pulmonary embolism, blood clot or heart attack while using testosterone medications, like AndroGel, please call us at (888) 606-5297 for a free consultation.

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