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FDA Requires New Heart Attack Warnings on Testosterone Products

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On March 3, 2015, the FDA issued a drug safety communication warning men about using testosterone replacement therapy products to treat symptoms of normal aging. They also announced that they are requiring testosterone drug manufacturers to add new warnings on product labels, indicating that they can increase risk of heart attack and stroke.

This warning comes a little over a year after the administration first sounded the alert about testosterone replacement drugs. That was in January 2014, when they indicated they were investigating the risk of stroke, heart attack, and death in men taking testosterone products.

Men Taking Testosterone for Symptoms of Aging

According to the new safety communication, the FDA reiterates its position that testosterone replacement drugs should be prescribed only to men who have low testosterone levels caused by a medical condition. The safety of these medications have not been established, the administration states, “for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”

Over the past several years, largely as a result of product advertising, men have been asking their doctors for testosterone to help combat symptoms like fatigue, low libido, and muscle loss—all normal parts of aging that may not be related to low testosterone.

The Endocrine Society recommends that men use testosterone supplements only when low levels are confirmed by repeated laboratory tests. Researchers showed in a 2014 study that 40 percent of men in the U.S. had no testosterone test at all before starting to take the drugs, and 50 percent had only one test.

Meanwhile, a number of studies have linked testosterone drugs with an increased risk of cardiovascular problems. In 2013, the Journal of the American Medical Association (JAMA) found that men 60 years and older had a 30 percent increased risk of stroke, heart attack, and death when prescribed testosterone therapy over men who didn’t take the drugs.

A second study found that men 65 years and older had a two-fold increased risk of heart attack within the first 90 days of starting testosterone replacement therapy. Younger men in the same study who had a pre-existing history of heart disease also had a two- to three-fold increased risk of heart attack in the first 90 days.

FDA Gives New Recommendations for Testosterone Therapy

The FDA stated that they are requiring additional warnings on testosterone drugs after extensive review of the current evidence, and after receiving expert info from the FDA Advisory Panel that convened last September. The panel recommended back then that the FDA increase the warnings on the products to alert doctors and their patients to the risks.

“Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting,” the FDA states, “FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use.”

The FDA reiterates that health care professionals should prescribe testosterone therapy only to men with low levels caused by a medical condition and confirmed by laboratory tests. They add that doctors need to make patients aware of the risks, and that men should report immediately any symptoms of heart attack or stroke, including chest pain, shortness of breath, and slurred speech.

Meanwhile, several men have filed testosterone replacement therapy lawsuits against manufacturers of products like AndroGel, Testim, and Depo-Testosterone. All federal cases were transferred to the Northern District of Illinois last June.

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  1. JEFF says:
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    IVE HAD SEVERAL TESTS SEVERAL YEARS APART THAT CONFIRMED I HAD LOW TESTOSTERONE. IVE BEEN ON INJECTIONS FOR SEVRAL YEARS AND HAVE HAD SOME ACNE BUT THATS IT . GREAT DRUG WHEN EXCERCISE AND EATING RIGHT IS INVOLVED. I HAVE BENEFITED FROM TESTOSTERONE REPLACEMENT.