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New FDA Warnings About Testosterone Replacement Drugs

According to a recent news article from Fox, the United States Food and Drug Administration (FDA) has issued new warnings about the dangers of testosterone replacement therapy drugs.

button-2-1355974-m.jpgThese testosterone replacement therapy drugs, which now come in the form of injections, oral tablets, creams, gels, and even a deodorant stick, have been marketed as a treatment for male weight gain, muscle loss, fatigue, mild depression, erectile dysfunction, loss of libido, and other symptoms of normal male aging. One doctor featured in this news story said there has been essentially “knee jerk” reaction to these signs of aging to prescribe testosterone replacement therapy drugs.

This recent push for TRT is not supported by scientific research and seems to be completely driven by marketing claims of large drug companies. Some in the medical profession believe that even if testosterone replacement therapy doesn’t work, it won’t harm anyone who takes it. According to the FDA, this is not necessarily true.

There has been a showing of a two-fold increase in the rate of heart attack and stroke for patients over the age of 65, and in the case of younger men, a risk of stroke or heart attack three times higher than those not taking testosterone replacement therapy drugs. This is especially significant as testosterone replacement drugs are being given to younger men than ever before. It should be noted that, while doctors are allowed to prescribe a medication for an “off label” use, the FDA has not authorized testosterone to treat lower testosterone levels in otherwise healthy males. In the 1970s, when testosterone replacement therapy drugs were first introduced to market, they were labeled for the rare condition of hypogonadism. Hypogandism is a serious testosterone-related medical condition where the body is not able to produce any testosterone hormone on its own.

As our Boston testosterone replacement therapy injury lawyers understand, while use of testosterone has increased over 400 percent over the past decade, there has not been a corresponding increase in the number of hypogonadism cases.

Testosterone replacement therapy drugs are making billions of dollars in profits for drug companies that make them. Many of these doses of TRT drugs are being dispensed at Low T clinics, which have sprung up across the nation, as opposed to traditional doctors’ offices where medical professionals are less likely to prescribe testosterone hormone without sufficient testing and an actual diagnosis of hypogonadism.

Meanwhile, at Low T clinics, FDA has found hundreds of thousands of patients are not even being tested for, let alone diagnosed with, a low testosterone level. What is actually happening is men are being asked to list their symptoms and are not given a blood test. If a male patient has the symptoms of normal male aging, the clinic would administer a dose of hormone replacement therapy based on these symptoms, along with any confirmatory testing.

While many doctors treat a suspected illness based on symptoms without ordering confirmatory tests, FDA is very concerned about the risks of serious illness, and how little is known about these risks.


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

Additional Resources:

FDA issues new warning about testosterone drugs, Mar. 11, 2015, Fox News

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