Stores pull cold drugs

The FDA warns that PPA, an ingredient also found in diet drugs, might cause strokes in users younger than 50.

By WES ALLISON

© St. Petersburg Times, published November 7, 2000

Dozens of brands of cold medications and weight-loss aids were being pulled from pharmacy shelves nationwide Monday after the federal government warned that a common ingredient might cause fatal or debilitating strokes, especially in young women.

The U.S. Food and Drug Administration's advisory against using phenylpropanolamine hydrochloride, or PPA, will affect millions of users of over-the-counter and prescription nasal decongestants, from to Triaminic to Dimetapp to Bayer Children's Cold.

It also is the active ingredient in over-the-counter appetite suppressants, including Dexatrim.

Americans buy about 6-billion doses of it a year. Stopping its use will prevent 200 to 500 hemorrhagic strokes among people younger than 50 each year, the FDA estimates.

"We suggest you stop taking the drug immediately and use an alternative," warned the unusually strong FDA advisory to consumers, which is available on the Internet at www.fda.gov/medwatch.

"Although the risk of hemorrhagic stroke is very low, FDA has significant concerns because of the seriousness of a stroke and the inability to predict who is at risk," the agency said.

"FDA does not consider the conditions for which (PPA) is used as justifying the risk of this serious event. Other products are available for use."

People were advised to check the active ingredient of cough and cold medicines for phenylpropanolamine (fee-nil-pro-pan-ol-a-meen). Other over-the-counter drugs are readily available, including standard antihistamines, nasal sprays and products that contain pseudoephedrine, such as Sudafed.

No over-the-counter alternatives are available for appetite suppressants, however, so users will have to talk to their doctors about prescription versions.

The FDA said it plans to ban PPA, but that can take months. In the meantime, it has asked pharmaceutical manufacturers to voluntarily quit selling products that contain it, or to use a substitute for PPA as active ingredient.

The drug industry, however, contends its products are safe and called for more study. Some manufacturers and retailers were pulling products from stores Monday, while others hadn't decided what to do.

"The individual companies are reviewing this and making their own individual decisions regarding their products," said a statement from the Consumer Healthcare Products Association, which represents the makers of over-the-counter medicine. "We look forward to this continued dialogue with FDA." The FDA's warning comes at the start of the lucrative cough and cold season. PPA is highly effective for relieving symptoms and is often paired with other medications, such as aspirin. It works by drying mucus membranes, stopping running noses and dripping eyes, and it won't make you drowsy.

"I didn't even get past the Ds, and there were like 100 already," said Ann Lumia, pharmacy manager at St. Joseph's Hospital in Tampa, as she scanned an alphabetical list of products that contain PPA.

Despite the recalcitrance of some in the industry, many pharmacies on Monday began yanking products with PPA.

Walgreen's, which has more than 3,200 stores, including 497 in Florida, and led the nation's pharmacies in sales last year, also re-programmed its cash registers to stop the sale of such products.

"It's a tough call. It really is," said Carol Hively, a Walgreen's spokesperson. "But we don't want there to be any doubt . . . if there's some question that this could be harmful to some people."

Largo-based Eckerd took a less sweeping approach. Rather than pulling medications, the company will provide each store with a list of products that have PPA and "provide signage . . . reminding customers to consult their pharmacists with any health care questions."

"Eckerd will continue to monitor the situation closely and act accordingly once the FDA panel announces its final ruling regarding phenylpropanolamine," a company statement said. Customers may return unused portions of medicines for a refund.

Monday's warning caps a long-simmering debate over the safety of the drug, which has been for sale for nearly 30 years. Reports of PPA-related hemorrhagic strokes date to 1979. The warning came two weeks after an FDA advisory panel determined there was a link between using PPA and hemorrhagic stroke, or bleeding in the brain, among people between the ages of 18 and 49.

Such strokes usually occur in the elderly and should be extremely rare among people younger than 50. The panel based its findings largely on the results of a recent Yale University study, funded by the pharmaceutical industry, that showed the link. Women who used diet pills had the highest incidence of stroke, the study said, but it's unclear why women were most affected.

It's also unclear how the drug causes strokes, but PPA constricts blood vessels and can raise blood pressure. This year, 45 PPA-related strokes, including four deaths, have been reported to the FDA, but such reports are voluntary and the agency says adverse reactions to PPA are vastly underreported. Most likely aren't detected.

"I think the concern is that the use . . . is so widespread, people tend to self-medicate, so there's a potential for a lot of people to be taking these drugs . . . without advice from their physician," Lumia said. "They may have risk factors already and may be increasing their risk of stroke."

It is important to check cough and cold products before deciding whether to use them because one product might contain PPA, while a similar product by the same company might not. Dimetapp Cold and Fever Suspension, for example, does not, but Dimetapp Allergy Sinus Caplets do. Contac-12 does, but five other Contac products don't.

The Associated Press reported that Whitehall-Robins Healthcare quit shipping Dimetapp with PPA on Monday. Liquid Dimetapp formulas that don't have PPA will head for stores next week, with pills to follow. Also, check Robitussin-CF -- some stores sell PPA-containing versions and some sell a new, non-PPA formula.

Top-selling manufacturers that did not 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, the AP reported.

"One of the reasons we put out the advisory is to give people the information before the regulatory process works through," FDA spokesperson Laura Bradbard said.

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