- The Washington Times - Tuesday, November 7, 2000

The Food and Drug Administration warned Americans yesterday not to buy dozens of over-the-counter cold and weight-loss medications that contain an ingredient that can cause strokes, particularly in young women.

Rite Aid, CVS Pharmacy and Walgreen Co. immediately pulled the products including Alka-Seltzer Cold & Sinus effervescent tablets, Dimetapp Cold & Allergy, Tavist-D Allergy/Decongestant, Triaminic and Robitussin CF cough syrup. But other stores, including Giant Food, left that decision to the drug makers.

The FDA warning comes as cold and allergy sufferers flock to pharmacies in search of decongestants, many of which contain phenylpropanolamine, or PPA, which has been found to cause hemorrhagic strokes, or bleeding in the brain.

All over-the-counter appetite suppressants, such as Dexatrim and Acutrim, also contain the chemical.

"We are telling consumers to read the label, and if there is PPA in [the medications], our suggestion is to look for alternatives," said Laura Bradbard, a spokeswoman for the FDA.

Those alternatives include cold medications like Tylenol, Sudafed, TheraFlu, Excedrin, NyQuil and DayQuil, Cepacol and Advil, which do not contain the ingredient.

Some types of Alka-Seltzer and Robitussin are also PPA-free.

Ms. Bradbard said some drug makers may choose to issue recalls, but no companies made such a move yesterday.

"We are saying don't market it, so that would indicate you don't want it on the shelf," she said.

The FDA plans to ban PPA and has told drug makers to find a replacement for it soon. The next step is for the agency to issue a proposition to ban PPA, followed by a public comment period. The FDA then would make a final decision about banning it. In the meantime, the agency has told the companies to voluntarily withdraw the medicines.

"This could take many months, and in the meantime consumers have the information so they can make a decision," Ms. Bradbard said.

Pharmaceutical giant SmithKline Beecham PLC said it has stopped making a version of its Contac cold capsules, its only product containing PPA. The company also asked retailers to take the product off store shelves.

Some 98 percent of PPA-containing drugs sold last year were cough and cold products; the other 2 percent were diet aids.

The FDA issued a consumer advisory and posted yesterday on its Web site a new study linking PPA to hemorrhagic strokes, particularly in young women. But the study said men were susceptible as well.

Conducted by the Yale University School of Medicine, the study found that patients between the ages of 18 and 49 who used products with PPA were more likely to suffer from the strokes than those who used other products.

Diet pills were especially dangerous, the study said, estimating that the risk of stroke was 16 times higher in people who use PPA-containing weight-loss pills than in those who don't.

The study compared 702 male and female stroke victims with 1,376 men and women who were healthy.

The chemical has been under suspicion since the 1980s when several young women suffered from strokes just days after taking appetite suppressants.

"There has been research on this subject going on for a long, long time, so many of the companies knew this was in the works and that there were potential problems," Ms. Bradbard said.

The FDA has records of 44 stroke cases caused by PPA-containing drugs. But the agency said the chemical could be blamed for hundreds more.

Hemorrhagic strokes are uncommon and rare in people younger than 50. They can be deadly or leave survivors disabled.

Rite Aid, based in Harrisburg, Pa., ordered its stores to pull products with PPA off their shelves yesterday afternoon.

"Depending on the store, we expect to start pulling products tonight," said Jody Cook, a company spokeswoman.

CVS and Walgreen also are removing products with PPA. Safeway officials did not return phone calls.

A Giant Food spokesman said the grocery stores would pull drugs with PPA off their shelves if the drug makers asked them to.

• Tim Lemke contributed to this article, which is based in part on wire service reports.

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