Issues Consumer Warning on Products Containing PPA
As expected, the FDA yesterday issued a public warning to consumers to immediately stop using any product containing the substance phenylpropanolamine, or PPA, because it is believed to increase the risk of suffering a rare but deadly type of stroke, the Washington Post reports. The agency has asked drug companies to "voluntarily remove" PPA from the market, and several national drugstore chains, including Walgreens and CVS, have announced that they will remove all products containing PPA from their shelves. "We don't want to be alarmist, but it is important for consumers to know there are real risks associated with taking this ingredient," Charles Ganley, director of the FDA's nonprescription drug division, said. "The adverse effects are rare, but they can be fatal while the conditions treated by the ingredient are not," he added. A recent Yale University study linked PPA, an ingredient found in many cold and cough medicines, such as Contac and Triaminic, and in all appetite suppressants, to an increased risk of stroke in women, leading government officials to examine the safety of the chemical. Since not all products sold under a specific brand name contain PPA -- for example, some versions of Contac do not contain the substance -- the FDA cannot recommend that consumers avoid all products sold under certain brand names. "Sometimes PPA is in a particular brand of medication, and sometimes it is pseudoephedrine," which is safe, Ganley said. Ganley urged consumers to examine the list of ingredients on the product's package or bottle. Ganley added that the FDA will propose a formal new rule limiting the use of PPA soon (Kaufman, Washington Post, 11/7). To enact a permanent ban on PPA, the FDA must first issue a new regulation governing over-the-counter products and seek public comment. The agency must then initiate separate proceedings to remove the ingredient from prescription drugs. These measures could take months, however, and the agency decided to issue the warning to notify consumers immediately of the safety risk (Stolberg, New York Times, 11/7).
The FDA has asked drug companies to remove PPA from the market, but because the agency cannot yet legally ban PPA or order a recall of products containing the substance, products with PPA "may remain on some store shelves for weeks or months while the agency seeks to force a complete withdrawal." In response to the FDA warning, some drug companies halted shipment of products containing PPA, others said they planned to replace PPA with another ingredient and still others said they were "uncertain" about whether they would honor the FDA's request (Washington Post, 11/7). Nonetheless, the public advisory warning sent pharmaceutical companies "scrambling" to respond to the edict. The Consumer Healthcare Products Association, a pharmaceutical industry trade group, has defended the safety of the substance "when used as directed." "CHPA members continue to stand by the safety of PPA-containing products when used according to label directions," CHPA Senior Vice President Dr. R. William Soller said. "However, our members acknowledge the FDA's action and its decision to initiate a new regulation to address PPA's safety," Soller added (New York Times, 11/7). Bayer Consumer Care Division stated that while increased risk of stroke could be linked to PPA in appetite suppressants, "there is no research clearly connecting the strokes with PPA in cold medicines." However, Bayer has agreed to reformulate its Alka-Seltzer Plus products to exclude PPA (Washington Post, 11/7). Drug giants Bristol-Myers Squibb and SmithKline Beecham also stated yesterday that they would stop marketing cold medicines containing PPA. "We do believe that PPA had a demonstrated record for 50 years of market use. But nevertheless the FDA has made a decision. We fully intend to comply with it," Bristol-Myers spokesperson Patrick Donohue said (New York Times, 11/7). Other companies have not revealed their future plans concerning the chemical. Novartis Corp., maker of Triaminic and Tavist-D, and Dexatrim manufacturer Chattem Inc. have "refused" to disclose what steps they will be taking concerning their products (Neergaard, AP/Philadelphia Inquirer, 11/7).
Although PPA is contained in many popular cold medicines, including versions of Comtrex, Contac, Dimetapp, Robitussin and Triaminic, consumers won't have to suffer through the cold and flu season without medical relief, according to Dr. John Fling, an allergy and immunology specialist at the University of North Texas Health Science Center. Fling urged people to use nasal sprays or other decongestants containing pseudoephedrine, which is found in products such as Sudafed (Yednak, Ft. Worth Star-Telegram, 11/7). The FDA has also set up a toll-free hotline for consumers with questions about PPA (AP/Philadelphia Inquirer, 11/7). A list of products containing PPA can be found on the New York Times Web site at http://www.nytimes.com/2000/11/07/national/07LIST.html. The FDA has also dedicated a section of its Web site to consumer information about PPA, which can be found at http://www.fda.gov/cder/drug/infopage/ppa/default.htm.