Pharmaceutical

Testosterone therapy makers face thousands of lawsuits

Low T1 Testosterone therapy makers face thousands of lawsuitsSteve Schabel, a married father of three, said he began testosterone therapy in 2013 to treat depression and boost his sex drive. He started with the gel and then switched to an injection. A week later, he was hospitalized with a life threatening double pulmonary embolism, or blood clots in the lungs.

Shabel had no prior history of heart problems. He has recovered but must take blood thinners for the rest of his life. He is now one of several men who is suing the manufacturer of his testosterone replacement treatment claiming the company engaged in questionable marketing practices to push sales of the hormone and failed to warn of the potential for blood clots, heart attacks, strokes and death with testosterone treatments.

More than 2,000 lawsuits have been filed by men who claim they suffered injuries from testosterone treatments. Shabel’s lawsuit is one of several that have been consolidated into one courtroom in Chicago.

Testosterone replacement therapies have raised red flags with the Food and Drug Administration (FDA). The hormones are intended for men who have hypogonadism, a condition in which too little or no testosterone is produced by the body due to disease or injury. It is not intended to treat age-related hypogonadism.

However, drug companies, seeing the boom of Viagra sales, sought to capitalize on a “fountain of youth” treatment for men in order to boost sales. Direct-to-consumer advertising campaigns by manufacturers coined the phrase Low T and encouraged men to ask their doctors if they were candidates for testosterone therapy. The drugs, manufacturers claimed, could help boost sex drive, improve muscle mass, and aid in weight loss.

The campaigns worked, resulting in skyrocketing sales of testosterone treatments. Later studies revealed that most of the prescriptions were written for men whose blood was never checked to determine if testosterone levels were low and called for treatment.

Concern increased when studies linked testosterone supplements to an increased risk of heart attacks, strokes, and death. Earlier this year the FDA added blood clot warnings and the possible risk of cardiovascular events to the safety labels of the drugs. The agency also ordered the prescribing information be rewritten to clarify that the drugs should not be used for age-related hypogonadism.

Source: Chicago Tribune