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FDA Cautions Men Using Testosterone of Increased Risk of Heart Attack and Stroke

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Since last year, The Food and Drug Administration (FDA) has been cautioning the public about prescription testosterone products on the market today. Some studies have been released that report a higher risk of heart attacks, strokes, or death in patients who are treated with testosterone therapy.

The products make claims that they are ideal for men with low testosterone levels caused by medical conditions. They are not to be used for the treatment of low testosterone levels due to aging, even if the man displays symptoms related to low testosterone.

The FDA now requires that manufacturers of T-therapy products update all labels to better identify the approved uses of these medications. Disorders that cause low testosterone and require testosterone replacement therapy via a FDA-approved, doctor prescribed product include:

  • Disorders of the testicles,
  • Disorders of the pituitary gland
  • Disorders of the brain that cause hypogonadism
  • Failure to produce T-hormone because of genetic problems
  • Damage to the testicles from chemotherapy or infection

They also ask that manufacturers add information about the increased risk of heart attack or stroke in patients taking testosterone. The FDA has known for a long time that testosterone is being used by men who merely have low testosterone due to age, but their approval for this use has never been granted. The risk of heart attack and stroke is just too real for them to allow such a large portion of the population to start on testosterone replacement therapy.

Patients using testosterone should be aware of the symptoms of a heart attack or stroke, such as chest pain, shortness of breath, weakness on the left side of the body, and slurred speech. One or more of these symptoms in a patient using T-replacement therapy should be taken by ambulance to the nearest emergency medical center.

Testosterone products are now shown to possibly increase the risk of both heart attacks and strokes due to the use of testosterone. Health care professionals must make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. For list of FDA-approved testosterone products, visit Drugs@FDA.

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