Pharmaceutical

Auxilium to take hot seat in latest testosterone side effects trial

Low T1 Auxilium to take hot seat in latest testosterone side effects trialWeeks after two juries handed down multi-million verdicts to two men who claimed that AbbVie Inc., did not adequately warn of cardiovascular risks with its testosterone replacement therapy AndroGel, drug maker Auxilium Pharmaceuticals LLC will take the hot seat in court over allegations that its testosterone treatment Testim caused a man to suffer a heart attack.

Steve Holtsclaw is one of thousands of men alleging manufacturers of testosterone replacement therapy misrepresented what their products were safe and effective to treat while failing to warn that the drugs increased the risk of heart attacks, strokes and blood clots.

Holtsclaw claimed he used Auxilium’s Testim for seven months before suffering a heart attack. He said his doctor prescribed the hormone therapy to treat his chronic fatigue – a condition for which testosterone treatments are not approved. Yet, Auxilium misled the public about what the drug was approved to treat, while also failing to warn that Testim could increase the risk for cardiovascular events, his lawsuit alleges.

Testim, as well as other testosterone replacement therapies, are only approved to treat hypogonadism, a condition in which men do not produce enough testosterone due to damage, defect or injury to the testes. Drug companies pushed their testosterone therapies to treat a collection of age-related symptoms they claimed were caused by a made-up condition called Low T. The aggressive marketing resulted in skyrocketing sales.

Holtsclaw’s claims are similar to the two that had already been tried, the first of which resulted in a $150 million verdict and the second in a $140 million verdict. Both trials involved AbbVie, and both juries cited the drug company’s misleading marketing of its testosterone in their high-dollar verdicts.

Source: Law360