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FDA: Testosterone Therapy is not Approved to Treat Low Tesosterone in Aging Men

By Burg Simpson
March 9, 2015
3 min read


On March 3, 2015, the FDA announced that it will require manufacturers of testosterone drugs to change their labels to notify patients and doctors that testosterone has not been tested or approved to treat low testosterone levels due to aging.

Read the FDA’s March 3, 2015, Safety Announcement.

Testosterone has Not Been Tested to Treat Symptoms of “Low T” in Aging Men

Testosterone drugs are improperly and widely prescribed to men who suffer from reduced testosterone levels associated with normal aging.  However, the drug companies that sell these products have never tested them to determine whether they are a safe or effective treatment for those symptoms of “Low T” that are experienced by most men as a result of the normal aging process.  The FDA is recommending that these products only be prescribed to men with low testosterone levels caused by certain medical conditions.

Testosterone drugs are only approved for use in men diagnosed with “hypogonadism” that is caused by a medical condition – these conditions are very rare and affect only a small number of men.  According to the FDA:

“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, the 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.”

Low testosterone, or “Low T”, is not a disease recognized by the medical community.  This has not stopped drug makers from selling these products to millions of men who experience symptoms of reduced testosterone, such as reduced sex drive, decreased energy, decreased strength or endurance, erectile dysfunction, and mood changes or depression.  All of these symptoms are normal effects of the aging process.

Drug companies generate hundreds of millions of dollars each year from the sale of these products.  Prior to the FDA’s March 3, 2015, Safety Advisory, drug companies did not tell doctors and patients that there is no evidence that using testosterone drugs results in any health benefit for men with low testosterone levels due to normal aging.  As a result, millions of men have been exposed to an increased risk of life-threatening blood clots, strokes and heart attacks, without any reason to believe that they will receive a benefit from these drugs.

This FDA advisory affects all of the testosterone replacement therapies sold in the U.S., including:

    • AndroGel
    • Androderm
    • Axiron
    • Fortesta
    • Testim
    • Striant
    • Delatestryl

Warning: Testosterone Drugs Increase the Risk of Life-Threatening Blood Clots, Heart Attack, and Stroke

The FDA is also requiring manufacturers of testosterone replacement therapy products to update labeling to warn of a possible increased cardiovascular risk associated with testosterone use.

The warning label already includes information about the risk of life-threatening blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients using testosterone drugs.  This warning information was added to the product label in June 2014.

Burg Simpson is currently investigating legal claims regarding men who suffered a stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT), or even death after taking testosterone drugs or starting Low-T therapy. Contact us today for a confidential, free, no-obligation consultation.

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