According to a recent news article from the Roanoke Times, doctors are concerned about the efficacy, safety, necessity and side effects of testosterone replacement therapy (TRT) drugs for many of the men who take them.
First it should be noted that testosterone replacement therapy has become big business over the past decade, and the hormone is available in many forms, including, but not limited to, hand gels, creams, oral tablets, injections, films placed under the tongue, and even deodorant. This article involves a woman whose husband takes testosterone hormone in the form of a skin gel, and she is worried that not only isn’t the drug helping her husband, but also it puts him in a bad mood all the time. A doctor consulted for this article discusses how this could be happening and discusses other issues with taking testosterone replacement therapy drugs.
This particular doctor has a problem with the pharmaceutical companies selling the concept of “male menopause” to millions of aging men and then telling them that they need to take testosterone replacement therapy drugs, as it is very irresponsible and, while it has led to huge profits for drug makers, it has resulted in the over-prescribing of the drug in an unsafe manner. He was not saying that there is no such thing as male menopause, but it is certainly not what the drug makers are claiming it is.
Not only is there a serious question as to whether taking testosterone hormone drugs will actually do any of things the drug companies are claiming it will, there is a real issue of safety. There has been very little long-term safety testing on taking the drugs to treat the signs of normal male aging, and we know that taking the drugs can increase the risk of heart attack and stroke.
Our Boston testosterone injury lawyers have worked with many victims who have been led by the commercials to take the drug and then ended up suffering from serious heart problems or a stroke as a result of taking the drugs. On top of these risks, as we have discussed, it doesn’t even seem like the drug is helping anyone.
One of the major problems, as this doctor sees it, is that all of these men are taking the drug for a use that was never approved by the United States Food and Drug Administration (FDA). Testosterone therapy drugs were originally approved in the 1970s to treat a very rare medical condition known as hypogonadism. This is a condition marked by a very low testosterone level caused by a defect in the hypothalamus or pituitary gland whereby the body does not develop as it is intended. This is the only condition for which the drug is currently labeled. This means that anyone who is given the drug that does not suffer from disease, which is basically everyone taking it, is being given the drug for an off-label use. This is allowed through a loophole in FDA regulations.
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.
Age Matters: FDA issues new warnings about testosterone use, November 19, 2016, By Dr. Michael Camardi, Roanoke Times
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