Testosterone is a naturally occurring, steroid-based hormone that is responsible for the development of reproductive tissues like testis and prostrates, and it key to the development of sexual maturity in males as is seen in the growth of muscles, bone mass and body hair. As men age, their testosterone levels may gradually decrease, a situation that can lead to an assortment of sexual and non-sexual symptoms ranging from psychological and emotional changes to those affecting the body physically and sexually.
Considering the consequences that can result from developing low testosterone levels, scientists have been researching treatment methods for hundreds of years. However, some of the earliest documented research attempts came about during the 1800s with the work of Arnold Berthold, who studied the difference between castrated and normal roosters in relation to sexual, behavioral and physical characteristics. His work was briefly followed by that of Charles Sequard, who participated in self-injections of animal testicles, reporting a change in his energy level and overall health in a medical publication. Following great ridicule, he abandoned his research of what would become known as testosterone replacement therapy.
It wasn’t until the late 1920s and early 1930s that scientists’ work with bovine testicles put testosterone research back on the map, and, in 1935, researchers in the Netherlands were credited as the first to isolate the testosterone hormone, which was identified in a published study. Although steady work was documented during subsequent decades, with many potential treatment modalities created, it wasn’t until 1953 when the U.S. Food and Drug Administration approved its first treatment for low testosterone patients.
Today, the FDA lists 29 different approved testosterone-based medications on its drug list. Among these treatments, often referred to as testosterone replacement therapies, are topical gels, transdermal patches, injections and a product called a buccal system, which is applied to the upper gum or inner cheek. Today, the most widely used form of therapy, however, is a gel therapy, which the Urology Care Foundation reports to being used by approximately 70 percent of low testosterone patients in the country.
In 2010, a study testing the effect of testosterone gel on the muscle functions of men who were at least 65 years old was published in the New England Journal of Medicine. Although many participants sited an increase in muscle strength, the study was discontinued when participants experienced cardiac, respiratory and skin problems. Similarly, a study published in the Journal of Clinical Endocrinology & Metabolism discussed the connection between testosterone and cardiovascular events as showcased in studies over a period of 43 years, from 1970 and 2013. According to the publication, researchers found participants were more likely to develop or die as a result of heart disease while seeking low testosterone treatments.
However, it was until Jan. 31, 2014, when the FDA announced it would be investigating the risk of stroke, heart attack and death associated with low testosterone therapy products. This change came after the publication of two studies, both unrelated and showcasing very similar results.
The first study, which was published in the Journal of the American Medical Association, offered a look at an observational study of older men in the U.S. Veteran Affairs health system. As part of this study, participants with low testosterone underwent imaging of the blood vessels of the heart to check for coronary artery disease. The study suggested participants prescribed testosterone therapy had a 30 percent increase in the risk of having a stroke or heart attack – both conditions having the ability to be fatal.
The second observational study, published in a journal called PLOS ONE, reported an increased risk of heart attack in older men as well as increase in younger men with pre-existing heart disease. Both sets of men were on testosterone therapy prescriptions. Within 90 days, the study reported the risk of heart attack doubled for the men over the age of 65 and either doubled or tripled for those participants under the age of 65 with pre-existing heart disease. However, younger participants without a history of heart disease did not have an increased risk of heart attack.
Although researchers are still examining the risks associated with the testosterone replacement therapies, the FDA advises patients to continue taking their medications as prescribed by their doctors.
If you or a loved one has experienced a stroke or heart attack – conditions that can be debilitating and fatal – call the Farr Law Firm at 1-855-327-7529 today. Our team of experienced lawyers are ready to help assert your legal rights.