Pharmaceutical

Former FDA chief calls AndroGel ads misleading

androgel pump 435x435 Former FDA chief calls AndroGel ads misleading AbbVie Inc. misled the public by aggressively promoting its testosterone replacement therapy AndroGel for off-label uses, said the former commissioner of the Food and Drug Administration (FDA). The statement was part of expert testimony in a case of a man alleging AndroGel caused him to suffer a massive heart attack, Law360 reports.

David Kessler, who served as FDA commissioner from 1990 to 1997, said that AbbVie promoted its testosterone gel directly to men by fabricating a condition called “Low T” to treat symptoms such as low libido, weight gain and muscle loss. AbbVie understood that those symptoms, as well as a drop in testosterone, are natural parts of aging, Kessler explained. AndroGel and testosterone replacement products in general are only for men with low levels of testosterone due to injury or disease, a condition called hypogonadism.

Kessler gave the testimony as an expert witness in the case of Jesse Mitchell, who sued AbbVie in 2014. He claims he used AndroGel for several years off and on before suffering a massive heart attack. Mitchell claims that men like him were targeted by AbbVie, but that the drug company never disclosed the cardiovascular risks associated with use of their products.

Studies have linked testosterone replacement therapy to an increased risk of heart attacks, strokes, blood clots and death, especially in older men. Kessler said that AndroGel was never found to be safe and effective for older men with testosterone deficiencies.

Mitchell’s case is one of thousands filed against AbbVie and other drug companies in a multidistrict litigation consolidated in Illinois. Mitchell’s is the second bellwether to go to trial, the first of which ended in a mistrial after the plaintiff’s lead attorney fell ill. That case is expected to be retried in September.

Source: Law360