Pharmaceutical

First Low T side effects trial to begin June 5

Low T1 First Low T side effects trial to begin June 5The first trial among more than 2,000 in a class-action lawsuit accusing several manufacturers of testosterone treatments of not adequately warning users of the potential for cardiovascular side effects with use of the hormone therapy, is scheduled to begin June 5, according to the Cook County Record.

The class action lawsuits date back to 2014 and name drug companies such as AbbVie, Besins, Eli Lily and GlaxoSmithKline. The lawsuits were consolidated in the U.S. District Court for Northern Illinois in Chicago.

Plaintiffs allege the testosterone replacement therapies were promoted for off-label uses, including diabetes, AIDS, cancer, depression and anxiety. Specifically, those suing the drug companies say that the testosterone makers invented a nonexistent condition they called Low T, and promoted testosterone therapy as a cure for symptoms such as low libido, weight gain, and muscle loss.

However, plaintiffs argue, testosterone treatment is ineffective for such off-label uses and can even put users at risk for heart attacks, strokes, blood clots and death.

Testosterone replacement therapy is approved by the Food and Drug Administration (FDA) to treat hypogonadism, a condition in which the body does not produce enough of the male hormone. Aggressive marketing by testosterone manufacturers has resulted in skyrocketing sales of the drug, and prompted the FDA to tighten prescribing indications. Studies showing increased cardiovascular risk with use of the product also led the FDA to require new warnings on testosterone treatments.

Seven cases in the class action have been singled out as bellwethers, with the first six involving AbbVie’s top-selling AndroGel. The seventh is suing Besins. The first trial is scheduled for June 6 with the remaining bellwethers scheduled through April 2018.

In May, U.S. District Judge Matthew Kennelly denied AbbVie’s motion to dismiss plaintiffs’ off-label marketing claims. However, Kennelly also dismissed plaintiffs’ claims of negligent design defects.

Source: Cook County Record