Pharmaceutical

AbbVie tries to skirt testosterone risk claims

androgel pump 435x435 AbbVie tries to skirt testosterone risk claimsAbbVie Inc., faced with thousands of lawsuits alleging the drug company downplayed heart attack and stroke risks with its testosterone treatment AndroGel, told an Illinois federal jury that there was no definitive link between use of its hormone replacement therapy and cardiovascular risks, Law360 reported.

The drug company told jurors during opening statements at the trial of Jesse Mitchell that it was not obligated to warn patients about the risk of heart attacks. Mitchell claims he used AndroGel off and on for several years before suffering a massive heart attack in 2012. He blames the event on his use of AndroGel.

Mitchell’s¬†lawsuit is one of thousands in a multidistrict litigation (MDL) consolidated in Illinois federal court alleging AbbVie and other manufacturers aggressively marketed their testosterone treatments directly to consumers for unapproved uses and failed to adequately warn consumers of the risks associated with use.

Testosterone replacement therapy is indicated for men who do not produce enough of the male hormone due to a defect or injury. It is not intended for men who experience a natural drop in the hormone as they age. But AbbVie and other manufacturers made up a condition they called Low T, telling men that testosterone treatments could improve libido, mood and muscle loss, lawsuits allege.

Mitchell argued that there were plenty of studies that testosterone treatments could cause heart attacks, strokes, and death. In 2014, the same year Mitchell filed his lawsuit, the Food and Drug Administration (FDA) required makers of testosterone therapies to conduct studies to better understand the cardiovascular risks associated with the drug. The FDA also required drug companies to add heart attack, stroke and blood clot risks to the safety labels of their testosterone products. The agency also required more clarifying language for the prescribing of the hormone treatment.

Source: Law360