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FDA Requires Label Change for Low Testosterone Products

March 5, 2015 Drug Injuries

FDA Requires Label Change for Low Testosterone ProductsIn January 2014, the FDA announced it would investigate claims of increased heart attack, stroke or cardiac death associated with testosterone replacement therapies.

FDA Concludes Investigation of Low-T Drugs

On March 3, 2015, The FDA announced the requirement of a label change for all testosterone products. The FDA now requires manufacturers to add information to the labeling about the possible increased risk of heart attacks and strokes in taking prescription testosterone. The FDA also cautions using testosterone products for low testosterone due to aging, and reiterated that testosterone prescriptions are only approved for men who have low testosterone levels caused by certain medical conditions and confirmed by lab testing.

FDA Aware of Testosterone Replacement Injuries

“Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”

A November 2013 study, published in the Journal of American Medical Association (JAMA), reported a 30 percent increase in risk for stroke, heart attack, and death in men age 60 and older who had been prescribed testosterone, compared to those who were not prescribed testosterone replacement.

Side Effects Associated with Low-T Drugs:

  • Heart Attack
  • Stroke
  • Death
  • Pulmonary Embolism (PE)
  • Deep Vein Thrombosis (DVT)

Low-T Injury Lawsuits

If you or a loved one has taken a prescription testosterone replacement drug and suffered from a heart attack, stroke, pulmonary embolism, or deep vein thrombosis, contact us for a free case evaluation.

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