This drug was used in over-the-counter products, such as cough and cold medicines and diet pills. We represented many clients against various manufacturers. The use of phenylpropanolamine (PPA) was banned in late 2000 because users had strokes due to hypertensive attacks. Our firm successfully handled cases involving death and stroke from the use of PPA. In fact, our firm began litigation on behalf of a client who suffered a devastating stroke in 1993. Her case was resolved very favorably in 1999, one year before the now famous Yale University study that confirmed the relationship between this over-the-counter drug and stroke through an elevated blood pressure mechanism. Litigation is over now, but PPA has been removed from all products and generally replaced with a similar drug, pseudoephedrine. Ironically, pseudoephrine had been used for many years before being replaced by PPA.
Two of our cases involved Alka Seltzer Plus, which contains PPA, and is sold as a cold remedy, specifically for nasal congestion. Two of our clients, who were also taking a prescription medicine, developed a hypertensive crisis and stroke soon after using this product. In one of those cases, involving a famous New York photographer, death occurred within a matter of hours of PPA use. Another case we recently settled involved Tavist-D, made by Novartis (formerly Sandoz), which was taken as a cold remedy. Our client in that case, a 29 year old woman with no prior medical problems, suffered a hypertensive stroke after taking PPA. This was written up on the front page of The New York Times, Dec. 13, 2000. Another case we resolved involved PPA in a product sold for weight reduction because of its inherent appetite suppression effect.
The Yale study demonstrated a significant risk of hemorrhagic (bleeding stroke) in users of PPA, with or without concurrent use of other drugs. On the strength of that study and numerous side effect reports, a FDA advisory panel warned in October 2000 that the use of PPA in over-the-counter drugs was unsafe and should be removed from non-prescription drugs. Other safer drugs were available for the same purposes for which PPA was used. Close on the heels of that advisory warning, it was announced that the FDA has moved to ban over-the-counter sales of PPA because of the increased risk of hemorrhagic stroke for users. The manufacturers of PPA have removed their products from store shelves in the wake of the FDA's actions.
Litigation revealed that many drug companies were concerned about PPA's hypertensive effects. Internal documents showed that the concern was so great, alternative active ingredients were being considered years before the FDA demanded reformulation.
