OTC DRUGS: FDA Panel Advises Ban on Cold Drug Ingredient
A panel of scientists recommended yesterday that the FDA ban the use of phenylpropanolamine, or PPA -- a common ingredient in decongestants and appetite suppressants -- in over-the-counter drugs, citing new evidence that the chemical may "increase the risk" of stroke among young women, the New York Times reports. While FDA is not legally bound by the recommendation, the agency usually follows the counsel of its outside experts (Stolberg, New York Times, 10/20). The 14-member panel of scientific advisers yesterday voted 13-0, with one abstention, that PPA "cannot be classified as safe, a classification critical to a drug's ability to sell without a prescription." With the FDA already considering a ban on non-prescription PPA, the panel's decision "strengthens that possibility" ( AP/Washington Post, 10/20). According to Dr. Eric Brass, chair of the advisory panel and of the department of medicine at the Harbor-UCLA Medical Center, PPA "did not meet the burden of proof for safety," (New York Times, 10/20). The committee voted after several hours of debate over the merits of a Yale University study that linked PPA and hemorrhagic stroke among young women taking appetite suppressants containing the compound (Rubin, USA Today, 10/20). In the five-year study, researchers compared 702 patients ages 18-49 who suffered hemorrhagic strokes, an "uncommon" stroke caused by bleeding in the brain, with 1,376 people in a control group. The study found that among women, the risk of hemorrhagic stroke jumped as much as 15 times for those who had used appetite suppressants in the three days prior to the stroke, while those taking PPA products for the first time had three times the risk of hemorrhagic stroke. Based on the results, Brass urged women to "try alternative products rather than PPA," although all over-the- counter appetite suppressants contain the ingredient.
Drug Industry Balks
Some scientists, who spoke on behalf of the nonprescription drug industry, called the Yale report "flawed," arguing that the study used "too few patients" and failed to account for other factors - - such as drug abuse or excessive caffeine use -- that may have contributed to strokes. The Consumer Healthcare Products Association, the industry's trade group, hired the scientists to review the $5 million Yale study, which was also funded by CHPA. "This is a failed study," Dr. Lewis Kuller, an epidemiologist at the University of Pittsburgh, concluded. Dr. R. William Soller, senior vice president of the CHPA, added, "Our members stand behind PPA as safe and effective products when used according to label directions" (New York Times, 10/20). Drug makers also insist that concerns over PPA remain "overblown" and devoid of "proof" that the drug causes strokes (AP/Washington Post, 10/20).
Midnight for PPA?
Meanwhile, Dr. Robert DeLap of the FDA's Center for Drug Evaluation and Research did not specify when the FDA would issue a ruling on PPA, but urged women to "carefully read the label on the packages of these products." While the FDA has received 44 reports since 1969 that patients taking PPA suffered hemorrhagic strokes, the agency has allowed the chemical to remain on the market, calling evidence about its risk "inconclusive." According to FDA official Dr. Lois La Grenade, however, "The figure of 44 is literally the very tip of the iceberg." The agency has estimated that PPA causes 200 to 500 strokes each year in patients ages 18 to 49. Dozens of medicines contain PPA, including some Alka-Seltzer, Dimetapp, Robitussin and Triaminic products, as well as the diet pills Dexatrim and Acutrim (New York Times, 10/20). Each year, Americans take about 4.5 billion doses of PPA, the FDA reported (USA Today, 10/20).