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FDA Issues Warnings for Testosterone Supplements

Over the past decade, we have seen a tremendous increase in the number of men taking testosterone replacement therapy (TRT) drugs.  These drugs were originally developed for treatment of a relatively rare medical condition known as hypogonadism. That is the condition for which these drugs were approved by the United States Food and Drug Administration (FDA) in the 1970s.

monitorHowever’ that’s apparently not the reason hundreds of thousands of men are taking these drugs. The real reason these men have been taking TRT medicaitons is because of the many television commercials and magazine ads that tell us that taking testosterone supplements will help with all of the “symptoms” of normal male aging. This includes lowered libido, weight gain, fatigue, mild depression, loss of muscle tone and so on.  The FDA has not approved the drug for this use, and doctors and researchers have not seen that taking testosterone will actually help “treat” any of these conditions. However, despite the lack of scientific evidence, testosterone replacement therapy has become big business.  Testosterone replacement drugs come in a variety of forms, including hand gels, deodorant sticks, pills, injectables, skin creams, and even sublingual films like the fresh breath strips that were once a fad. While there is little scientific evidence that testosterone supplements do what the makers claim they do, there is evidence that taking them can increase a man’s risk for stroke and heart disease, as our Boston testosterone injury attorneys have seen in many cases over the years.

Even though there has been considerable evidence of the dangers of testosterone supplements, the drug companies that manufacture them have been repeatedly claiming they are perfectly safe.  However, according to a recent news release from WebMD, the FDA has just issued a series of warnings about the dangers of taking testosterone supplements.  Specifically, the FDA has said that taking testosterone and other related anabolic or androgenic steroids is linked to heart attacks as well as various other serious medical conditions, including personality changes and infertility.  The FDA has also issued warnings that testosterone and these related steroids are also easily capable of being abused.

This will lead to major labeling changes whenever testosterone replacement therapy hormone is administered to men to treat what drug company advertisements call the medical condition of low testosterone.  It is important to keep in mind that while the FDA is obviously aware the vast majority of patients taking testosterone therapy drugs are not suffering from hypogonadism, they have not approved this type of use.  This is not to say that giving (selling) testosterone to this hundreds of thousands of men is illegal, but it is only done as a result of a loophole in FDA regulations that allows a drug to be prescribed for an off-label use, so long as doctors are treating based upon symptoms alone.

As for the anabolic steroids, they are a synthetic derivative of testosterone and are able to legally prescribed to children with delayed puberty and other disease such as HIV/AIDS, because these conditions cause a breakdown of muscle tissue.

If you are the victim of Massachusetts product liability, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

Additional Resources:

FDA Warns of Dangers From Testosterone Supplements, October 26, 2016, By Robert Preidt, WebMD

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