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FDA warns Americans to stop using remedies containing PPA

November 06, 2000

FDA warns Americans to stop using remedies containing PPA



By LAURAN NEERGAARD / AP Medical Writer


WASHINGTON - The government warned Americans Monday to quit using dozens of over-the-counter cold remedies and diet pills that contain an ingredient that could cause hemorrhagic strokes, especially in young women.

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The Food and Drug Administration is preparing to ban phenylpropanolamine, or PPA, which is found in products from Dexatrim to Triaminic. But legal steps needed for a ban will take a few months, so the FDA asked manufacturers Monday to voluntarily stop selling PPA-containing drugs immediately - and replace the ingredient with a safer alternative.

For consumers, the FDA's unusually strong health warning says: "We suggest you stop taking the drug immediately and use an alternative."

Consumers should look for PPA in the ingredient list of all nonprescription cold relievers - brand names and generic or store brands - and choose decongestant pills containing the safer alternative pseudoephedrine or use nasal sprays instead, said FDA nonprescription drugs chief Dr. Charles Ganley.

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There are no over-the-counter alternatives for diet pills, however, so dieters will have to consult a doctor about prescription-only alternatives, Ganley said.

Some retailers and manufacturers moved Monday to take products off drugstore shelves.

Don't use PPA-containing Contac 12-hour Cold Capsules, but five other Contac versions contain the safer pseudoephedrine, so check the label, said manufacturer SmithKline Beecham Consumer Healthcare.

Whitehall-Robins Healthcare quit shipping PPA-containing Dimetapp on Monday. New liquid Dimetapp formulas that don't contain PPA will head for store shelves next week, with pill versions to follow later. Also, check Robitussin-CF - some stores are selling PPA-containing versions and some are selling a new non-PPA formula, in boxes flagged with a yellow band.

"Customers that are looking for an alternative should ask one of our pharmacists or ask their doctor," said Michael Polzin of Walgreen Co., which began pulling all PPA-containing products from its 3,200 stores in 43 states.

CVS Pharmacy announced Monday that it also was removing products with PPA from the shelves of its 4,100 stores in 25 states and the District of Columbia.

Even though manufacturers learned three weeks ago that the FDA's move was coming - when the agency's scientific advisers declared PPA unsafe - many spent Monday scrambling to decide what to do.

Top-selling manufacturers that refused to reveal their plans include Novartis Corp., maker of PPA-containing Triaminic and Tavist-D; Bayer Corp., maker of Alka-Seltzer Plus cold medicines; and Chattem Inc., maker of Dexatrim diet pills.

About 6 billion doses of PPA are sold in this country each year, the vast majority without a prescription. However, there are a few PPA-containing prescription decongestants, and the FDA asked their makers also to stop selling them while it moves to ban prescription use as well.

The risk of a hemorrhagic stroke, or bleeding in the brain, is very small to an individual user.

"Not to be alarmist - it's clear this is a very rare event," Ganley said. "But even though it's rare, it's an irreversible event."

These are often deadly strokes, and survivors can be left disabled. With millions of Americans swallowing PPA daily, the FDA estimated it could be to blame for 200 to 500 strokes just in people under age 50.

Hemorrhagic strokes typically occur in the elderly, and are extremely rare under age 50. Yet the first warning sign about PPA came in the 1980s, when medical journals cited several dozen young women who suddenly had strokes days after taking their first diet pill.

The FDA's records show 44 cases of hemorrhagic stroke among PPA users in the past 30 years. Most were women; the median age was 35 - including a few who died while using diet pills even though medical records showed they weren't fat.

But the drug industry called the concern overblown and successfully argued more research was needed. So the industry's Consumer Healthcare Products Association funded a five-year Yale University study comparing PPA use among stroke survivors with healthy people.

The study's conclusion: PPA increases stroke risk for young women within three days of taking PPA-containing appetite suppressants, or within three days of taking their first-ever PPA dose for any reason. In some cases, using PPA increased stroke risk 12- to 15-fold.

Nobody knows why, although first-time PPA use sometimes temporarily raises blood pressure, an effect that wanes as the body gets used to the drug. Risk was highest with the higher doses - more than 75 milligrams daily - that dieters typically used.

The study didn't find men at risk, but the FDA cautioned that enough men weren't studied to be sure they're OK.




On the Net: FDA's PPA information: http://www.fda.gov/cder/drug/infopage/ppa/default.htm

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