Voluntary Pullback of Cold Drugs Confuses Consumers

After the Food and Drug Administration warned consumers against using dozens of over-the-counter cold medicines and diet pills earlier this month, manufacturers began voluntarily pulling them off the market.

Now, many consumers are finding empty shelves at drug stores where their favorite remedies used to be.

The FDA asked manufacturers to voluntarily remove products containing phenylpropanolamine--PPA--after studies showed it could cause hemorrhagic strokes, especially in young women.

Although the risk of stroke is considered small, consumers take 6 billion doses of PPA products annually--from Alka-Seltzer and Robitussin to Dexatrim and Acutrim--and the FDA decided to ask manufacturers to stop selling the products as it takes steps to formally ban the chemical.

“We suggest you stop taking the drug immediately and use an alternative,” an FDA warning states.

That leaves consumers like Susan Lefko without one of her favorite cold remedies.

“We use Alka-Seltzer all the time,” the Towson, Md., resident says. “It has always worked great. I hate that it is being recalled because I don’t know what I am going to use.”

Manufacturers are working to provide alternative medicines, but it remains to be seen whether they will be available for this year’s cold and flu season.

Officials at Whitehall-Robins Healthcare, which manufactures eight Robitussin and Dimetapp products that contained PPA, hope to have modified medicines--which use a safer compound called pseudoephedrine--on shelves by the middle of next month. The makers of Alka-Seltzer, the Bayer company, said its eight new products will be available early next year.

Laura Perry of Towson discovered that the bottle of Robitussin she bought last month contained PPA, but she might use it anyway. “I am not one of these people who is worried about it,” she says of the health risk.

But Teresa Goodson of Baltimore is heeding the FDA warning. A regular user of Dimetapp, Goodson says, “I won’t use any of these products again.”

The removal of the products from the shelves is confusing because only some brands of popular cold remedies contain PPA. For example, Contac 12-hour Cold Capsules contained PPA, but five other versions of Contac contain the safer alternative. Manufacturer SmithKline Beecham Consumer Healthcare ordered the PPA products pulled earlier this month, and spokeswoman Nancy Loure says company officials are still discussing whether to replace the Contac 12-hour Cold Capsules.

Before buying over-the-counter cold remedies and diet pills, the FDA advises consumers to read labels to make sure PPA is not one of the ingredients.

That may be harder than it sounds. Many people get phenylpropanolamine confused with pseudoephedrine, the alternative compound, according to Ed Castle, a pharmacist at the Giant Food store in Towson.

“They are both long words,” Castle says, “and 99% of the people don’t know how to pronounce either one.”

If there is any question about ingredients, the FDA recommends that consumers ask pharmacists or store managers for help.

As to whether consumers should throw out PPA cold medicines and diet pills they have at home, or try to exchange the products or get refunds, Donna Edenhart, a spokeswoman for the Consumer Health Care Product Assn., says: “We encourage [customers] to contact the individual companies.”

Some manufacturers have set up toll-free numbers and Web sites to deal with customer questions and to offer refunds or exchanges.

“We are trying to get as many [PPA products] back from the shelves as possible,” says Fran Sullivan, a spokesman for Whitehall-Robins Health Care. The company will offer rebate coupons to consumers, Sullivan says.

PPA is a mild amphetamine-like chemical that relieves nasal congestion by constricting blood vessels in the nose.

The FDA’s move to ban the compound stems from a five-year study at Yale University that found a small increase in the risk of stroke among young women using PPA products.

Since 1979, there have been 30 reported cases of hemorrhagic stroke--bleeding in the brain--most commonly among women between the ages of 17 and 45, who were using appetite suppressants for the first time.