The United States Food and Drug Administration (FDA) is now investigating reports of serious testosterone side effects and now major lawsuits have been filed against Abbott Labs and AbbVie Inc. The suits allege that the companies which make AndroGel testosterone replacement hid major risks. According to reports men between the ages of 50 and 65, are claiming that they suffered serious side effects as a result of using AndroGel. Among the alleged side effects were heart attacks, stroke, and a mini-stroke.
According to the case of Aurecchia v. AbbVie Inc.,case number 1:14-cv-772, filed in Chicago, AbbVie and Abbott “misrepresented that AndroGel is a safe and effective treatment for hypogonadism or “Ölow testosterone,’ when in fact the drug causes serious medical problems, including life-threatening cardiac events, strokes, and thrombolytic events.” The court documents argue that the defendants engaged in “disease mongering” by linking a variety of symptoms to low testosterone (“Low T”) – including listlessness, moodiness, and increased body fat – when those symptoms could be caused by a variety of things, including natural aging. The lawsuit notes that AndroGel’s sales increased to more than $1.37 billion per year due to the marketing campaign. The lawsuit also argues that studies suggest testosterone is linked to an increased risk of heart attacks and strokes. Those studies include a 2010 New England Journal of Medicine study that was discontinued after a high number of men in the testosterone group suffered adverse events and a November 2013 JAMA (Journal of the American Medical Association) study that suggested testosterone therapy increased the risk of death, stroke and heart attack by approximately 30 percent.
In January 2014, the FDA announced it was investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products. The investigation was undertaken following studies suggesting an increased risk of cardiovascular events possibly linked to these products. The FDA has only approved testosterone products for men whose testosterone levels are low “in conjunction with an associated medical condition.”