Pharmaceutical

AndroGel makers failed to warn about risks

androgel pump 435x435 AndroGel makers failed to warn about risksAbbVie Inc.’s did not properly test its testosterone replacement therapy AndroGel for cardiovascular risks and failed to warn doctors and patients of those risks, an Illinois federal jury found before ordering the company to pay a whopping $140 million dollars in punitive damages plus an additional $140,000 in compensatory damages to a Memphis, Tennessee man.

Jeffrey Konrad, who is in his 50s, was prescribed AndroGel in 2010 to treat symptoms of so-called Low T, including low libido, muscle loss and weight gain. But two months after starting treatment he suffered a heart attack. He sued AbbVie in 2014. His lawsuit alleged that Abbvie was aware of studies that showed testosterone replacement therapies were linked to heart attacks, strokes, and blood clots, some of which have been fatal.

Yet, the company pushed sales of the male hormone in ads aimed directly to consumers that promoted AndroGel as a treatment for the symptoms of Low T. Konrad’s attorneys argued that Low T is not the condition for which testosterone treatments are intended.

Two years ago, the Food and Drug Administration (FDA) cracked down on the wide prescribing of testosterone treatments, and cited studies that linked to drug to cardiovascular risks. The agency also ordered testosterone manufacturers to update their safety labels to reflect the increased risk of heart attacks and strokes, and told doctors that they should only prescribe the treatment for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.

The verdict comes just months after another federal jury awarded a man $150 million in punitive damages, but did not find AndroGel to be the cause of the man’s heart attack.

Source: Commercial Appeal