FDA Warns About the Use of Testosterone Products

Food and drug Administration


March 3rd, 2015 – The Food and Drug Administration is requiring the makers of testosterone products to amend their labels, clarifying the uses of these increasingly popular supplements. In addition, manufacturers will also be required to include disclaimers about possible increased risk of heart attack and stroke due to the use of testosterone supplementation. After conducting exhaustive research into the side effects of these products, the FDA has concluded that supplement makers are not providing sufficient information to consumers regarding the risks and uses.

For the Millions Who Supplement Testosterone

We are pleased to see that the FDA is finally taking a more definitive stance on this very important issue, but unfortunately it comes too little too late for millions of men who have relied on supplementation to treat their low testosterone – or perceived low testosterone – without being made reasonably aware of the risks.

The Potential Dangers

Testosterone therapy is recommended only for men with documented low testosterone levels, as determined by comprehensive medical testing. It should not be viewed as a solution for men merely exhibiting signs or symptoms of low testosterone, and must always be administered under careful medical supervision. Merely experiencing a low libido, fatigue, or reduced muscle mass does not automatically make one a candidate for testosterone therapy, and even in cases of legitimate testosterone deficiency, all patients must understand the tradeoffs associated with this type of treatment.

The FDA report concludes that testosterone use may be correlated with increased risk of heart attack, stroke, or even death. The research consisted largely of aging men, and while the findings weren’t entirely conclusive, they were correlative enough to warrant the amended labeling requirement.

Has Your Health Suffered as a Result of Testosterone Supplementation?

If you or someone you love has experienced heart attack, stroke, or even death after receiving testosterone treatment, you may be entitled to compensation. Nadrich & Cohen, LLP is actively working with patients and the families of patients who have suffered severe side effects from testosterone therapy. Contact us today at 310-826-8082 for a free and confidential consultation, and learn your options.

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