FDA Targeting Diet Drugs for Heart Studies (Deja Vu All Over Again)
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
Vivius Inc (Qnexa), Orexigen Therapeutics Inc. (Contrave), and Arena Pharmaceuticals Inc. (Lorcaserin) are the latest pharmaceutical companies moving for FDA approval of prescription weight-loss drugs. These companies are in the process of conducting clinical trials or actually close to producing data to federal agencies for approval.
Our firm represented hundreds of clients against American Home Products, which quietly changed its name to Wyeth during the litigation. The Mayo Clinic discovered and published medical reports that diet drug users developed heart valve injuries, many of which were irreversible. A fatal lung disease, now know as pulmonary arterial hypertension, was the worst problem. Wyeth was in possession of side effect data but denied its existence to the Mayo Clinic and the FDA, only later to actually file supplemental adverse event reports long after the fact, and after it was too late for many users.
Amazingly, Xenical and Meridia were subsequently approved and also later found to cause heart problems. Most shocking is that these costly diet pills have never proved to have significant, permanent weight loss in combination with provable reduction in obesity-related illnesses in those using the drugs.
Over the counter products that had ephedra and phenylpropanolamine were associated with heart attacks and strokes due to blood pressure spikes. Our firm had leadership positions in litigation committees and also litigated cases to verdict. In fact, our suits resulted in manufacturers halting sales long before the FDA removed these ingredients from the market.