Cold Remedies Pulled After FDA Warning

A number of major drug store chains are pulling dozens of over-the-counter cold remedies and diet pills from their shelves after the government warned that an ingredient could cause hemorrhagic strokes, especially in young women.

The Food and Drug Administration issued an unusually strong warning Monday, telling Americans to immediately quit using drugs containing phenylpropanolamine, or PPA, which is found Dexatrim, Tavist-D and dozens of other over-the-counter medicines. The agency, which intends to ban the ingredient, asked manufacturers voluntarily to stop selling PPA-containing drugs immediately and to replace the ingredient with a safer alternative.

Rite Aid, CVS & Walgreen

Rite Aid, with 3,800 drug stores in 30 states and the District of Columbia, soon will begin posting warning signs and removing products with PPA, spokeswoman Jody Cook said.

“We would advise our customers to check with the pharmacist about the alternatives,” she said.

CVS Pharmacy, which has 4,100 stores, and Walgreen Co., with 3,200 stores, made similar announcements.

Dr. Charles Ganley, the FDA’s nonprescription drugs chief, said buyers should be alert for PPA in the ingredient list of nonprescription cold relievers — both brand names and generic or store brands — and instead choose decongestant pills with the safe alternative pseudoephedrine or use nasal sprays.

Over-the-counter alternatives do not exist for diet pills, however, so dieters will have to consult doctors about prescription-only alternatives, Ganley said.

Some Plans Revealed

Whitehall-Robins Healthcare quit shipping PPA-containing Dimetapp on Monday. New liquid Dimetapp formulas lacking PPA will head for store shelves next week, with pill versions to follow. Also, some stores are selling PPA-containing versions of its Robitussin-CF product, and some are selling a new non-PPA formula, in boxes flagged with a yellow band.

SmithKline Beecham Consumer Healthcare said people should not use its PPA-containing Contac 12-hour Cold Capsules, but five other Contac versions contain the safe pseudoephedrine.

Even though manufacturers learned three weeks ago that the FDA was preparing to act, when the agency’s scientific advisers declared PPA unsafe, many scrambled Monday 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.

6 Billion Doses Per Year

About 6 billion doses of PPA are sold in this country each year, mostly without prescriptions. 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.

While the risk of a hemorrhagic stroke, or bleeding in the brain, is very small to an individual user, 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 yearly just in people under age 50.

Hemorrhagic strokes typically occur in the elderly, and are extremely rare under age 50. In the 1980s, however, medical journals cited several dozen young women who suddenly had strokes days after taking their first PPA-containing diet pill.

A five-year Yale University study comparing PPA use among stroke survivors with healthy people concluded that 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.

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