The panel’s decision left drugmakers scrambling to reassure consumers and investors alike. “Our members continue to believe that PPA is safe and effective when used according to the label directions,” says Dr. R. William Soller, director of science and technology for the Consumer Healthcare Products Association (CHPA), a trade group for makers of over-the-counter medicines. PPA acts on the central nervous system to decrease appetite and relieves nasal congestion by reducing the swelling of blood vessels in the nose. It is included on the list of drugs banned by the International Olympic Committee. Bayer says it has sold billions of doses of PPA-based Alka Seltzer Plus over the last 30 years and has never had a report of stroke associated with its use.
But fighting the FDA seems futile, and some companies quickly felt the pain of a probable PPA ban. “We haven’t had a fun day today,” said Alec Taylor, president of Chattem Inc., maker of appetite-suppressant Dexatrim. Chattem’s stock dropped 22 percent last Friday, a day after the decision. The company sells about $20 million worth of Dexatrim with PPA each year. “I haven’t had one consumer call,” Taylor said as his stock fell, “but I’ve been swamped with calls from stockholders.” There are alternative decongestants, but PPA is the only FDA-approved appetite suppressant, which is why Chattem was hit so hard.
While the other companies with PPA products held their own on Wall Street, the writing is on the wall for the ingredient. Though drugmakers insist it is safe, some have already started to remove it from their products. Novartis Consumer Health, makers of Triaminic and Tavist-D, started planning months ago to replace PPA with pseudoephedrine, which has similar effects but is not associated with stroke risk. And Bristol-Myers Squibb is actively looking to remove PPA from its products, including Comtrex Deep Chest Cold & Congestion relief.
The FDA panel’s decision was influenced by a new Yale University study linking PPA to an increased risk of hemorrhagic stroke–bleeding in the brain. Drugmakers fault the study for, among other things, looking at too few cases. But the FDA says it’s received reports of strokes among PPA users since the 1970s–including 22 since 1991. “And these are strokes in people who just should not be having them,” says FDA spokesperson Laura Bradbard. That’s too high a price to pay to clear a stuffy nose or lose a few pounds.
