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FDA Advises Against Over-Prescription of Testosterone

Jasmine Roziers2 years ago

The United States Food and Drug Administration (FDA) has issued a warning addressing the over-prescription of testosterone products to men.

FDA Warns of Potential Heart Risks

According to Uncover California, the United States Department of Health and Human Services informed the FDA that doctors are prescribing testosterone for unapproved medical issues including fatigue and age-related low libido.

The FDA says that there is no evidence that testosterone products are effective in treating age-related issues. The FDA also warns that testosterone products carry significant risks including increased risk of heart attack and stroke.

Earlier this month, the FDA ordered that manufacturers of testosterone treatments put stronger warning labels on their products and conduct additional clinical trials to determine each individual products’ cardiovascular risks.

About Testosterone Products

  • Testosterone products such as Axiron, Androderm, and Androgel are only approved for the treatment of low testosterone levels caused by medical issues like hypogonadism.
  • Recently, testosterone has seen a spike in off-label use. As a result, the number of prescriptions written for testosterone products has jumped fivefold from 2000.
  • Adverse events linked to testosterone products include:
    • Heart attack
    • Stroke
    • Prostate disease
    • Liver toxicity
    • Reduced sperm count
    • Infertility
    • Death

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