More than six billion - that's billion! - doses of PPA , or phenylpropanolamine, had been taken annually by U.S. consumers in a variety of remedies and diet aids, including in prescription drugs and popular over-the-counter products. But after decades of use, the drug was linked to an increased risk of stroke, particularly in women. In late 2000, the U.S. Food and Drug Administration requested that all drug companies discontinue the use of PPA and reformulate their products using safer drugs.
Several years after requesting discontinuance of PPA, the FDA, in late 2005, proposed changing the classification of PPA as a nonmonograph Category II drug -- meaning it would not be recognized as safe and effective -- for use in over-the-counter nasal decongestants and weight control products. (See FDA News.)
More than 400 products were sold containing PPA, including variations of the following:
- Alka-Seltzer Plus
PPA was used in various products for more than 50 years to relieve stuffy nose or sinus congestion for cold sufferers and to act as an appetite suppressant in diet aids.
But alarm bells sounded over the medication after a study by the Yale University School of Medicine linked PPA use to hemorrhagic stroke (bleeding in the brain), most notably for women 18 to 49 years old. The study associated strokes with PPA because episodes occurred close in time to use of the medication. But perhaps a more convincing correlation was the fact that many of the PPA users who suffered strokes were otherwise healthy, often younger adults who were not otherwise likely candidates for stroke.
While the risk of stroke due to PPA use appears relatively low, it was estimated that the widely used drug was responsible for 200 to 500 strokes each year in the United States.
Kline & Specter PC, a Philadelphia-based law firm with some 30 attorneys, several of whom are also highly skilled doctors, handled PPA cases and has had success litigating product liability and prescription drug lawsuits in the Pennsylvania-New Jersey region and nationwide.