In January 2014, the FDA released information regarding the safety of testosterone products and an ongoing investigation of the risks of heart attack, stroke, and death among men using FDA-approved testosterone therapy. Recent studies have linked an increase for strokes and heart attacks to men taking testosterone products. AndroGel, Testim, Delatestryl, Fortesta, Bio-T-Gel, and Testopel are some of the FDA-approved testosterone drugs currently available by prescription.
Testosterone therapy is marketed toward older men, typically over 65, to increase sex drive and restore energy. The hormone is generally distributed in injection, patch or topical gel form.
According to the FDA, from 2002 to 2013 there were at least 44 cases of pulmonary embolism, 18 cerebral vascular episodes, 42 heart attacks, and 12 fatalities reported from users of AndroGel, a topical form of testosterone treatment. A report from Adverse Events, Inc. established testosterone as the primary cause of 479 hospitalizations, 105 of those being linked to heart attack or stroke, and 61 resulting in death.
Five users of AndroGel have filed lawsuits against the drug and its parent company, claiming to have experienced heart attacks or strokes while using the product. Those suing claim the company exaggerated the benefits of testosterone treatments in their television advertisements and failed to reveal the possible dangers associated with taking the hormone.
While the risk of cardiovascular issues from testosterone drug therapy has not been officially determined by the FDA, the treatment has only been approved for men with little or no testosterone levels and an associated medical condition. Associated medical conditions include hereditary complications, testicle malfunction as a result of chemotherapy, or hypothalamus and pituitary gland issues. The pituitary gland in the brain regulates testosterone production and can sometimes malfunction. A major cause for concern is that many men with regular testosterone levels, who do not have any of these conditions, are using testosterone drug therapy.
A study released by PLOS One demonstrated that in 55,000 men using testosterone therapy, the risk for heart attack doubled in men over the age of 65 and tripled for younger men with a history of heart disease. The FDA has encouraged patients and medical professionals to report any side effects experienced from using testosterone therapy.