Ingredient In Cold Remedies Poses Risk -

An ingredient in dozens of cough and cold medications and appetite suppressants increases the risk of suffering a rare but deadly type of stroke, federal health officials warned yesterday.

As a result, the Food and Drug Administration alerted consumers to immediately stop using any product containing the substance--called phenylprapanolamine or PPA--and asked drug companies to voluntarily remove it from the market.

Americans take 6 billion doses of the ingredient each year in a wide range of prescription and over-the-counter products, including those sold under the popular brand names Alka-Seltzer, Dexatrim, Robitussin-CF, Triaminic and Contac. PPA is also used in many generic and store brand cough and cold medicines.

Some drug companies yesterday stopped shipping products containing PPA, and others said they intended to replace PPA with another ingredient. Some were uncertain about whether they would honor the FDA's request. In the meantime, however, several national drugstore chains said they had begun taking PPA products off 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," said Charles Ganley, director of the FDA's nonprescription drug division. "The adverse effects are rare, but they can be fatal while the conditions treated by the ingredient are not."

Because the FDA does not have the legal authority to immediately ban the substance or force a recall, products containing the substance may remain on some store shelves for weeks or months while the agency seeks to force a complete withdrawal.

The drug industry has generally disputed contentions that PPA is unsafe, arguing that the ingredient has been used for decades and that the evidence for a possible risk of an unusual, "hemorrhagic" type of stroke caused by bleeding in the brain is unconvincing.

The organization that represents makers of nonprescription drugs and dietary supplements, the Consumer Healthcare Products Association (CHPA), said yesterday that its member companies are reviewing the advisory and will make their own individual decisions.

"CHPA members continue to stand by the safety of PPA-containing products when used according to label directions," said William Soller, the association's director of science and technology. "However, our members acknowledge FDA's action and its decision to initiate a new regulation to address PPA's safety."

While some manufacturers did not reveal their intentions yesterday, several national drugstore chains said that they will take all products with PPA off their shelves.

"The FDA is recommending that consumers no longer use the products, so we felt we should not sell them," said Michael Polzin, spokesman for Walgreens and its 3,200 stores. He said the store would be pulling about 75 products.

CVS/pharmacy also said it had begun removing products with PPA from the shelves of its 4,100 stores.

The FDA could not recommend that consumers avoid all products sold under specific brand names because they do not all always have the same active ingredients, Ganley said. For example, some versions of products carrying the Contac name contain PPA while others do not.

"Sometimes PPA is in a particular brand of medication, and sometimes it is pseudoephedrine," which is safe, Ganley said. "The consumer will have to look on the back of the bottle or package to see for sure."

Over-the-counter cold, cough and decongestant medications without PPA are available in drugstores, but the ingredient is contained in all nonprescription appetite suppressants on the market, Ganley said.

The manufacturers of several PPA-containing cold remedies, including Contac 12-hour Cold Capsules and Comtrex Flu Therapy and Fever Relief, told retailers yesterday to remove their products from store shelves. Bristol-Myers Squibb said most of its Comtrex products do not contain PPA.

Bayer Consumer Care Division, maker of Alka-Seltzer Plus cold products, said that while hemorrhagic stroke may be associated with PPA from appetite suppressants, there is no research clearly connecting the strokes with PPA in cold medicines. Nevertheless, the company said it will reformulate its product to exclude PPA.

Public health officials had been concerned about the compound since the 1980s. The FDA action came two weeks after a scientific advisory committee recommended PPA be removed. The committee's recommendation was based on a new five-year Yale University study that made the clearest link yet between PPA and an increased risk of hemorrhagic stroke.

The study of patients at 43 hospitals found that women aged 18 to 49 who had taken appetite suppressant with PPA were 16 times more likely to suffer a hemorrhagic stroke. (Researchers said there was no reason to believe men faced a lower risk.) Among men and women taking a cough or cold remedy containing PPA for the first time, researchers found, the risk of a stroke was three times higher than normal.

Though the agency has had only 44 confirmed reports of hemorrhagic stroke associated with PPA in three decades, FDA officials now estimate that 200 to 500 hemorrhagic strokes are PPA-related yearly.

While the FDA's action yesterday is not a recall, Ganley said the agency will propose a formal new rule limiting the use of PPA soon. He said that because of the possible health risks, the agency didn't want to wait any longer before issuing its warning.

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