8 Usuários Ativos. 08/09/2010 12:58:45
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Drugstore Chains Pull Ppa-Containing Products in Response to FDA Warning

MAJOR DRUGSTORE chains are pulling dozens of nonprescription decongestants and diet drugs from their shelves because the Food and Drug Administration is warning that a key ingredient could cause hemorrhagic strokes.

Phenylpropanolamine (PPA) is the active ingredient in dozens of over-the-- counter cold and allergy medicines, such as Dimetapp and Tavist-D, and weight-loss drugs such as Dexatrim and Acutrim. PPA works as a decongestant in cold and allergy remedies and as an appetite suppressant in diet drugs.

The FDA, which plans to formally ban PPA, asked pharmaceutical companies last Monday to voluntarily stop selling PPA-- containing drugs immediately and to reformulate those products with safer alternative ingredients.

The agency is drafting a proposed rule that would make the sale of PPA products, both prescription and over-the-counter, illegal. However, a final regulation is unlikely to take effect for several months, FDA says.

Health Canada is also asking consumers not to use products that contain PPA "in advance of the department's full evaluation of the scientific and medical questions." In Canada, the chemical is approved for use only in cold medicines.

The Consumer Healthcare Products Association, which represents the makers of nonprescription drugs, says it "continues to stand by the safety of PPA-containing products when used according to label directions." But senior vice-president William Soller adds that CHPA member companies "acknowledge FDA's action."

Whitehall-Robins Healthcare stopped shipping PPA-containing Dimetapp on Monday. New liquid Dimetapp formulas without PPA will head for store shelves next week, with pill versions to follow.

SmithKline Beecham PLC is halting the production and shipment of Contac 12-- hour cold capsules, the only Contac formulation that contains PPA. The company has also asked retailers to stop selling it.

Bristol-Myers Squibb Company will stop marketing its PPA products: Comtrex Flu Therapy and Fever Relief, Comtrex Deep Chest Cold and the cold remedy Naldecon.

Walgreen Company, one of the nation's largest drugstore chains, has directed its 3,200 stores to pull PPA products from shelves, and Rite Aid and CVS Pharmacy will post warning signs and remove products with PPA.

Dr. Charles Ganley, head of FDA's over-the-counter drugs division, says consumers should avoid both brand-name and generic products that contain PPA. Instead, they should use nasal sprays or choose decongestants with pseudoephedrine.

FDA has not cleared any alternative active ingredients for over-the-counter diet drugs, so consumers should consult doctors about prescription-only substitutes or use products with natural ingredients.

A five-year Yale University study comparing PPA use among stroke survivors and healthy people concludes that the chemical increases stroke risks for young women within three days of taking PPA-- containing appetite suppressants, or within three days of taking their first-ever dose of PPA for any reason. In some cases, using PPA may increase the risk of a stroke 12-- to-15-fold.

"We do believe their is some association between PPA and the risk for this event," says Dr. Ganley. "We don't want to be alarmist. It is a very rare occurrence, but once you develop it, it could be devastating."

At an FDA advisory committee meeting last month, FDA officials estimated that PPA might cause 200 to 500 hemorrhagic strokes per year in people under 50. About 6 billion doses of PPA are sold in the US each year.

The FDA panel recommends that PPA no longer be "generally recognized as safe," a requirement for over-the-counter drugs.

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