Case Info
Phenylpropanolamine
Phenylpropanolamine (PPA) works to clear nasal passages by constricting blood vessels, which become inflamed during infection. It was an ingredient in a number of over-the-counter cough, cold, and allergy medications such as Tavist-D. It was also commonly used in weight loss drugs.
Dexatrim, an over-the-counter dietary supplement that contained PPA, was manufactured originally by Thompson Medical Company in the 1970s. Thompson Medical Company merged with The Delaco Company in 1992, and eventually sold several of its brands, including Dexatrim, to healthcare manufacturer Chattem, Inc. in December 1998.
Safety Issues
PPA had been on the market since 1936, two years before the Food, Drug, and Cosmetic Act began requiring proof of safety and effectiveness. Drugs that on the market prior to 1938 were “grandfathered” in and, therefore, assumed to be safe and effective unless proven otherwise.
For a number of years prior to its forced withdrawal in December 2000, PPA had been suspected of causing harm. For years, many doctors theorized it significantly raised blood pressure, which could cause strokes. In 1981, the advocacy group Public Citizen, along with the Journal of the American Medical Association (JAMA), warned against the use of PPA in medications. Soon after consumer groups began calling for the ingredient’s recall.
PPA was not withdrawn from the market until November 2000, where the Food and Drug Administration raised concerns about PPA’s potential to cause a hemorrhagic stroke, with a study concluding that it may contribute to as many as 200-to-500 strokes annually.
In August 2001, a multidistrict litigation was established involving plaintiffs who took Dexatrim after Chattem, Inc. acquired the product in December 1998.
In April 2004, a preliminary class action settlement was approved, and plaintiffs were ultimately awarded over $40 million.