A recent study, published in the Journal of American Medical Association has many men who are currently taking a testosterone drug wondering about risks they may have been unaware of. This particular study concluded that men taking testosterone supplements had a 29% higher risk of experiencing a cardiovascular event such as heart attack or stroke and, in some cases, the risk could include death. Sales of testosterone drugs have skyrocketed; in 2008 testosterone supplements brought in about half a billion dollars, but by the end of 2012, that number was over $2 billion. The number of prescriptions during that same time period (including refills) went from less than 2 million to over 5 million.
Recent data from the Massachusetts Male Aging Study estimated that 2.4 million American men between the ages of 40 and 69 actually suffer from hypogonadism (a medical condition in which the body does not produce sufficient testosterone hormones). This would mean that over two million men may be taking testosterone supplements without a medical diagnosis of hypogonadism. Although the drug received FDA approval for the treatment of hypogonadism, endocrine tumors or for those men undergoing chemotherapy, off-label use of the drug is rampant, fueled by the aggressive marketing of testosterone by manufacturers.
It is a rare person who has not seen a commercial touting the benefits of testosterone supplements for men suffering from “Low-T.” Testosterone levels in men will naturally begin to decline after age 30, about 1-3% per year. This decline leads to a lowering of energy levels, a decrease in libido, erectile dysfunction, decreases in bone density, strength and muscle mass, and an increase in belly fat. In the past, these “symptoms” were considered nothing more than the normal effects of aging, however testosterone manufacturers are pushing the drug as a youth elixir which will help men regain what they have lost as they age.
AndroGel received FDA approval on February 28, 2000 for “replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.” Prior to that approval, a letter from the FDA dated October 21, 1999, was sent to Dr. Adrian S. Dobs, regarding an inspection done by the FDA on a clinical study for AndroGel. The letter stated the clinical trial had failed to comply with Federal regulations and acceptable standards of good clinical practice. Specifically, the deficiencies noted regarding the clinical trial included:
· Inadequate drug accountability
· Deviations from protocol
· Inadequate and/or inaccurate records
· Failure to report protocol changes
No mention was made of whether these deficiencies were properly corrected prior to the FDA approval of AndroGel.
Abbot and AbbVie, manufacturers of AndroGel may have the dubious honor of being the first to have lawsuits brought against them. Five men filed suit on February 4, 2014, alleging Abbot and AbbVie had failed to disclose the potential risks of AndroGel. Three of the men suffered a heart attack after starting AndroGel therapy, a fourth suffered a stroke, and the fifth a mini-stroke. While researchers are not entirely clear on why testosterone drugs may be causing adverse cardiovascular events, some believe the drug increases blood clotting. Because older men will typically have weaker arterial walls, this increase in blood clotting could lead to heart attack, stroke, deep vein thrombosis and pulmonary embolism.
Sales of AndroGel—the leading testosterone replacement product, with at least 60% of the market—began to slip last year, falling 21% in the last quarter. This decline was likely in response to the release of the November, 2013 study linking testosterone to heart attack, stroke and death.