Lawsuits within a newly established multidistrict litigation (MDL) involving claims against manufacturers of testosterone replacement therapies could climb into the thousands in the next several months, legal experts say. The lawsuits allege testosterone treatment makers withheld serious risks associated with the product while heavily marketing the therapy to consumers in an effort to drive profits.

Testosterone supplements, such as AndroGel, Testim and Axiron, were heavily promoted as treatments to remedy symptoms of low testosterone, or “Low T,” such as low sex drive, fatigue, muscle loss and weight gain. Thousands of men were lured by the “fountain of youth” the ads seemed to promise, resulting in skyrocketing prescriptions.

The benefits of the therapy quickly came into question when recent studies revealed that older men on testosterone therapy were at an increased risk of heart attacks, stroke and death. As a result of the studies, the Food and Drug Administration (FDA) launched an investigation into safety the safety concerns with testosterone treatments.

Though still under review, the FDA announced this week that the agency had found evidence that testosterone replacement therapy can cause dangerous blood clots in the legs, known as deep vein thrombosis. Blood clots in the legs can break loose, travel through the bloodstream and lodge in the lungs, blocking blood flow and resulting in a life threatening condition called pulmonary embolism.

The FDA is ordering makers of testosterone products to update their safety labels to include a new warning for blood clots. The drugs currently carry a warning of increased blood clot risk related to a condition called polycythemia. The new warning will include a newly recognized blood clot risk not related to polycythemia.

The FDA said it will continue its investigation into cardiovascular risks with testosterone treatments and will notify the public with its findings and any recommendations when its review is complete.

“We are currently evaluating the potential risks of … cardiovascular events (in patients using testosterone products), which are related to blood clots in the arteries,” the agency said in a statement.

Testosterone replacement therapy is a $1.6 billion industry in the United States. About 45 federal lawsuits have been consolidated into the MDL in the U.S. District Court for the Northern District of Illinois. More lawsuits are expected to be added to the MDL in the months ahead.

NBC News
Drug Watch

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