An avalanche of aggressive marketing for testosterone supplements has resulted in the number of men taking a testosterone drug quadrupling since 2000 in the United States. In contrast, the number of men in the United Kingdom taking testosterone drugs since 2000 has increased by only a third. A huge number of men taking a testosterone drug in the United States have not even had their testosterone levels measured; the FDA’s approval of testosterone drugs is only for men who make too little of the hormone on their own, leading to a condition known as hypogonadism as well as men with endocrine tumors or those undergoing chemotherapy.
The Effects of Aggressive Marketing Campaigns
The advertising campaigns for men with low testosterone imply that any man who has less energy, is not as strong as he once was, is suffering from low libido or has gained weight in the belly area could benefit from taking a testosterone supplement. What these commercials are not saying is that these “symptoms of Low-T” were once considered nothing more than the normal effects of aging. Men are not being told of the risks associated with testosterone therapy; even several years ago such potential side effects of testosterone as: a worsening of sleep apnea, an increase in red blood cells, worsening of prostate problems (including prostate cancer), liver and kidney disorders and the possible development of breasts were noted. Unfortunately, due to the lack of long-term studies on the effects of testosterone on men, the risks are largely unknown.
What the JAMA Study Said and How the FDA Responded
A study published in the Journal of American Medical Association in November, 2013, concluded that the risk of heart attack, stroke and death among men taking testosterone supplements was as much as 30% higher than men who were not taking the drug. Among otherwise healthy men, the question must be asked whether the benefits of testosterone therapy are truly worth the risks. The FDA has weighed in, stating it will look into the testosterone debate in order to determine the actual risks men face when taking the supplements. Testosterone supplements are available in creams, gels, patches, pills and implants.
Andro-Gel Lawsuits
The makers of Andro-Gel—Abbot and AbbVie—were recently hit with five lawsuits; three of the men claimed they suffered a heart attack after beginning Andro-Gel, one claims he suffered a stroke and the fifth alleges he suffered a mini-stroke. Abbot may have had some indication of troubles related to testosterone as far back as 2003, when a lawsuit was filed against Solvay Pharmaceuticals, which was later bought by Abbot. This lawsuit alleged False Claims Act violations, specifically claiming that off-label promotions of testosterone supplements resulted in millions of dollars’ worth of false claims submitted to governmental health care plans. T
The suit further alleged that Solvay conspired with doctors—even providing kickbacks—to increase off-label use of testosterone. A “leaked” document which surfaced during the lawsuit discussed the need to expand the testosterone market by at least 36.5% and recommended pushing the drug to primary care physicians who were more “easily influenced.” This lawsuit, which involves other Solvay drugs as well, is ongoing; Abbot did not purchase Solvay until some seven years after the lawsuit was filed. Annual sales in the U.S. of Andro-Gel currently top $600 million dollars.
Caution is Advised for Men Taking Testosterone Supplements
The bottom line may be that men should exercise caution when taking a testosterone supplement. There simply have not been the level of studies done on testosterone therapy that were done on women’s hormone replacements, and the real risks associated with testosterone drugs are simply not yet known. If you feel you have been harmed by a testosterone drug, first look after your health, then speak to an experienced testosterone drug lawyer in order to ensure your potential case is protected.