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Home / Uncategorized / FDA Evaluating Risk of Stroke, Heart Attack...

FDA Evaluating Risk of Stroke, Heart Attack and Death with FDA-approved Testosterone Products

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A possible risk of stroke, heart attack, and death in men has been linked to FDA-approved testosterone products, according to an FDA Safety Announcement.  The agency, responsible for protecting the public health, 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 men prescribed testosterone therapy.

The agency is continuing to evaluate the information from the testosterone therapy studies and will communicate their final conclusions and recommendations upon completion of the evaluation.

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. 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 is urging health care professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program.

View the full FDA Safety Announcement here.

Contact Longo Legal

If you or someone you know has been injured by testosterone therapy, call Longo Legal, PLLC to find out if you have a potential claim. The first step is to get some preliminary information over the phone. The initial phone call and consultation cost you nothing. You will not pay Longo Legal, PLLC anything towards your lawsuit unless a recovery is made on your behalf. Call Longo Legal at (855) 566-4648 to see if you qualify.

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