Makers of testosterone replacement therapies made up a condition called Low T and heavily advertised their products directly to men as treatments for symptoms like low sex drive, weight gain, muscle loss and mood swings. These ads lured men to ask for products like AndroGel by name, which in turn generated millions of dollars in sales for companies like AbbVie Inc. What testosterone manufacturers failed to tell consumers is that the treatments could put them at risk for life threatening cardiovascular events like heart attacks, strokes and blood clots.
Testosterone is an important male hormone involved in sex drive, sperm production, fat distribution, red cell production and maintenance of muscle strength and mass. Testosterone levels typically peak during adolescence and gradually decline around age 30 or 40. Testosterone therapies are intended for men with hypongoadism, a condition in which their bodies do not produce enough testosterone or have an impaired ability to produce sperm, or both. Hypogonadism is caused by defect, injury or disease.
But because of aggressive marketing tactics by testosterone manufacturers, men who were experiencing a natural age-related drop in testosterone were seeking testosterone treatments, resulting in a sharp increase in testosterone prescriptions. This prompted the Food and Drug Administration (FDA) in March 2015 to issue a Drug Safety Communication cautioning that prescription testosterone products are approved only for men with low levels of the hormone due to certain medical conditions and not for age-related hypogonadism because the safety and efficacy for this use has not been evaluated.
The FDA also cautioned that men – especially older men – who used testosterone treatments were at an increased risk for heart attack, stroke, blood clots (which can lead to deep vein thrombosis and pulmonary embolism), and death, including sudden cardiac death.
The warning was based on research, including a 2009 Boston Medical Center study that was abruptly halted after finding that older men with limited mobility treated with testosterone replacement therapy were at grater risk of developing adverse cardiovascular events such as heart attacks and elevated blood pressure. A later study revealed that men age 65 and older had a two-fold increased risk of heart attack in the first 90 days of initiating treatment with testosterone, and that younger men with a history of heart disease had a two- to three-fold increased risk of heat attack in the fist 90 days of treatment.
As a result, men who used the testosterone treatments and suffered injuries began filing lawsuits against the companies. In June 2014, the U.S. Judicial Panel on Multidistrict Litigation consolidated the testosterone lawsuits into a multidistrict litigation in the Northern District of Illinois, where currently about 6,500 cases are pending. At least two trials have resulted in multi-million-dollar verdicts for the plaintiffs. Some manufacturers, including Eli Lilly, Endo International, Auxilium and GlaxoSmithKline, have reached tentative settlements over their testosterone replacement therapies.
National Institutes of Health boston medical Center study testosterone older men halt
FDA Drug Safety Communication