Phenylpropanolamine in Medicines

by Food and Drug Administration (FDA)

On November 6, the Food and Drug Administration issued a public health advisory alerting consumers to stop using over-the-counter (OTC) and prescription drug products containing phenylpropanolamine because this ingredient has been associated with an increased risk of hemorrhagic stroke (bleeding in the brain).

Phenylpropanolamine is commonly used as a decongestant in OTC and prescription cough and cold medications and as an appetite suppressant in OTC weight loss products. FDA recommends that consumers check labels of OTC drugs for phenylpropanolamine and stop using products that contain this ingredient.

Those using a prescription decongestant or cough-cold product should ask their pharmacists and health providers if it contains phenylpropanolamine. A commonly used alternative decongestant is pseudoephedrine, and most manufacturers will reformulate cough and cold products using this ingredient, says Robert Sherman, a biologist with FDA's Center for Drug Evaluation and Research (CDER). "Although it is in the same drug class as phenylpropanolamine and is effective as a nasal decongestant, we do not have the same concerns with pseudoephedrine," he says. As for using phenylpropanolamine as an OTC appetite suppressant, there is no alternative OTC drug product.

FDA intends to proceed with the public rulemaking process that will propose the removal of phenylpropanolamine from OTC products. CDER sent letters to drug manufacturers, repackers, and distributors, requesting that they voluntarily discontinue marketing products containing phenylpropanolamine. This interim measure aims to protect the public's health while FDA moves forward with rulemaking to classify phenylpropanolamine as "not generally recognized as safe and effective."

About 10,000 hemorrhagic strokes occur each year among people aged 18 to 49 in the United States, and an estimated 200-500 could be associated with phenylpropanolamine, says CDER director Janet Woodcock, MD. "Though the risk of stroke is low," she says, "FDA is concerned because of the seriousness of the adverse event and advises consumers to stop taking products with phenylpropanolamine."

In October 2000, FDA's Nonprescription Drugs Advisory Committee voted that phenylpropanolamine should not be considered safe after it evaluated several reports, including a recent epidemiological study conducted by scientists at Yale University's School of Medicine.

The study enrolled 702 men and women ages 18 to 49 who were hospitalized because of hemorrhagic stroke and 1,376 control subjects who did not have strokes. Researchers found an association between phenylpropanolamine use and hemorrhagic stroke in women. Because so few men in the study were exposed to the drug, researchers couldn't determine if their risk is different from women's. So while the risk of stroke was found mostly in women, men may also be at risk.

FDA requested the Yale study because of previous reports of a potential association between phenylpropanolamine and hemorrhagic stroke. In 1976, an expert panel recommended that the ingredient be generally recognized as safe and effective as a nasal decongestant, and another expert panel made the same recommendation for weight control in 1982. FDA hadn't finalized phenylpropanolamine's safe and effective status because of concerns over occasional reports of stroke associated with the drug.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.