Pharmaceutical

AndroGel needed heart risk warning, witness says

androgel pump 435x435 AndroGel needed heart risk warning, witness saysPeggy Pence, the president and CEO of pharmaceutical consulting firm Symbion Research International Inc., told an Illinois federal jury that there was enough evidence that testosterone replacement therapies may cause heart attacks that warnings should be placed on the hormone treatments’ labels and further testing should be conducted, Law360 reports.

Pence told the jury in the first bellwether among thousands in a multidistrict litigation (MDL) to go to trial alleging cardiovascular risks with testosterone treatments that Abbvie had received so many reports of heart problems in patients who had used its AndroGel testosterone gel that further testing was warranted.

Pence is an expert witness in the case of Jesse Mitchell, who is suing AbbVie over claims he suffered a heart attack allegedly caused by his two-year, off-and-on use of AndroGel. He says when he started using the drug 2007 that there were no warnings on the safety label involving heart attacks, strokes, blood clots or cardiovascular death. His lawsuit claims that the drug company had plenty of evidence at that time that testosterone use carried heart risks.

Mitchell’s lawsuit claims that initial testing on AndroGel showed that several men suffered increased blood pressure, drops in healthy cholesterol, and higher blood clotting hormones. A second study conducted by AbbVie involved three men who suffered significant cardiovascular events including strokes and severe chest pain. However, the company didn’t let doctors or consumers know of these adverse side effects, the lawsuit alleges.

Mitchell is also accusing AbbVie of marketing the hormone for off-label use, so-called Low T. Testosterone treatments are intended for men with hypogonadism, a condition in which disease or injury results in low levels of the hormone. AbbVie promoted the drug to boost men’s testosterone to conquer symptoms of aging such as muscle loss, low libido and lack of energy.

Source: Law360