Product Liability Lawyer Blog
Testosterone replacement therapy is clearly a big money maker for the various pharmaceutical companies that manufacture the hormone. It has gotten to the point where you cannot watch a football game or NASCAR race without seeing more than one commercial for testosterone replacement hormone.
Testosterone replacement therapy hormone comes in a variety of forms, including injections, transdermal patches, gels, skin creams, sublingual films, and pills. They are heavily marketed to men who are experiencing the symptoms of normal male aging, including reduced libido, weight gain, loss of muscle tone, fatigue, and mild depression.
While the companies that make testosterone replacement therapy hormone say taking replacement hormone is essentially a quick fix for all of these symptoms or characteristics, many doctors are not so sure. The medical community is not sure what it means to have low testosterone and what is normal for aging men. They also do not know if there is any benefit to raising one’s testosterone level though taking hormone therapy, unless the patient’s levels are so low as to qualify for the rare disease of hypogonadism.
Not only is hypogonadism rare, it is the only use for which testosterone replacement therapy is actually approved. Using testosterone hormone to treat male aging at “Low T” clinics across the country, as our Boston testosterone replacement therapy injury attorneys can explain, is an off-label use that is legal as result of a loophole, but the FDA has not approved this specific type of use.
According to a recent news article from Healio, there may be issues assessing a patient’s testosterone serum level after taking a transdermal application of AndroGel, because a patient’s testosterone serum levels will vary throughout the day. As part of their continuing effort to gain FDA approval for testosterone replacement therapy approval in older men by expanding the diagnostic criteria of hypogonadism, the company has been conducting double blind pharmaceutical trials, which is often required when seeking FDA approval.
The company has just released information saying researchers found a wide variety of serum levels in study participants when they came in to provide blood samples. They believe this phenomenon has to do with the fact that a patient’s testosterone serum level will vary greatly throughout the day after taking AndroGel. These results were not seen in the case of study participants who were taking a placebo. Since the study was double blind, the clinical trial site and the patient were not supposed to know whether they were administered the actual drug or a placebo.
It is interesting to see what these results will be when the study is complete, because this is some of the first real scientific testing being performed to examine the effects of testosterone replacement, since everyone else has been relying on study data from the late 1960s involving hypogonadism patients, who are typically young.
While the scientific and medical community is not sure that there are any real benefits from taking testosterone replacement therapy drugs, it is well known that taking the hormone can lead to an increased risk of stroke and heart attack, as well as other serious medical conditions.
If you are the victim of Massachusetts product liability due to taking testosterone hormone, call Jeffrey Glassman Injury Lawyers for a free and confidential appointment — (617) 777-7777.
Additional Resources:
Serum testosterone levels vary throughout day following transdermal application, July 6, 2015, Healio
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Risk for Internal Bleeding after Taking Pradaxa, August 22, 2014, Boston Dangerous Drugs Injury Lawyer Blog