Attorneys are beginning to see an increase in claims from men who used testosterone supplements and suffered harm or injury, particularly in light of the results of a study on testosterone therapy which were published in the Journal of the American Medical Association in November, 2013. This study linked testosterone to serious side effects, including heart attack, stroke and death. The FDA has approved testosterone therapy only for the treatment of men with low testosterone levels who also have a medical diagnosis of hypogonadism, an endocrine tumor, are undergoing chemotherapy, or have other recognized medical conditions related to low testosterone.
The Explosion of Testosterone Prescriptions
Over 432 million testosterone prescriptions (including refills) were issued in 2013, up from 208 million in 2008. The market share of testosterone supplements is edging toward $2 billion dollars—a powerful reason for pharmaceutical companies to downplay the dangers of testosterone and continue to market the drug as a cure-all for all the normal symptoms of aging. Many doctors are prescribing testosterone treatments off-label to assist men who have lost muscle mass or strength, gained weight in their belly area, lost bone density or have seen a decrease in energy and libido.
The FDA Agrees to Take a Second Look at Testosterone Supplements
Before the release of the JAMA study, most doctors were unaware there were any risks associated with testosterone supplements. The FDA, while agreeing that testosterone supplements deserve a second look, along with more studies, have not said the drug is dangerous, instead telling doctors to carefully weigh the risk vs. benefit for each male patient prior to prescribing a testosterone supplement. The JAMA study showed that men taking testosterone supplements were more likely to have a heart attack, stroke, or even die during a three-year period than men of the same age who were not taking a testosterone supplement. The participants in the study were mostly over the age of sixty, and had other health problems, including high blood pressure, unhealthy cholesterol levels and diabetes.
Testosterone Manufacturers Disagree With the Results of the Study
A study in 2009 on the effects of testosterone on older men was discontinued as the rate of heart attacks among study participants continued to rise. There are a number of studies funded by the pharmaceutical companies who manufacturer testosterone which have concluded there is no increased risk of adverse cardiovascular events associated with testosterone drugs. Andro-Gel is a testosterone gel manufactured by AbbVie, formerly Abbot Laboratories; the supplement sports a black box warning label regarding the dangers of secondary exposure to testosterone in women and children.
Lawsuits Filed Against Abbot and AbbVie, the Manufacturers of Andro-Gel
Five lawsuits were filed on February 4, 2014 in an Illinois federal court against the manufacturers of Andro-Gel. These lawsuits claim Abbot and AbbVie concealed facts regarding the serious side effects associated with testosterone. One of the plaintiffs, Kenneth Aurecchia, claims he suffered a heart attack as a direct result of Andro-Gel use. Aurecchia also alleges physical and emotional damages after he took Andro-Gel for what he believed were symptoms of low testosterone—after aggressive commercial marketing of testosterone supplements. It is believed that many more testosterone lawsuits will follow; if you feel you are a victim of testosterone injury, speaking to an experienced testosterone injury attorney could be warranted.