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NOVEMBER 7, 2000

The Federal Drug Administration on Monday urged all consumers to stop taking commonly used cold and diet drugs because they contain an ingredient which can cause strokes, particularly in women.

But while the probability of a person having a hemorrhagic strokes due to use of the drugs is very low, the FDA considers the risk serious enough to warrant a public health warning. The FDA plans to bad the ingredient at a later date.

The FDA is targeting phenylpropanolamine, or PPA, which is used in a wide range of over-the-counter and prescription cough and cold remedies. These include Contac 12-Hour Cold Capsules, Dimetapp, Triaminic, and Tavist-D.

PPA is also found in diet drugs, including Dexatrim. But consumers are advised to check all the labeling on their products to determine if they contain PPA, as many drug companies are using a safe alternative.

For example, one versions of Robitussin-CF contains PPA while another does not.

The FDA is also asking drug companies to remove voluntarily products containing PPA from the market. As companies consider the move, stores such as Walgreens and CVS are already removing PPA products from their shelves.

The move the FDA comes after a meeting held last month to discuss the safety of PPA. Relying on a study conducted by the Yale University School of Medicine, the FDA says that women are at an increased risk of a hemorrhagic stroke within three days of using diet drugs or nasal decongestants.

Consumers who need alternatives to PPA drugs are advised to ask their physician or a pharmacist. The FDA has a toll-free PPA line at (888) INFO-FDA and they can also be reached at (301) 827-4570.

In response to the FDA advisory, Health Canada of Canada has also issued a warning to consumers. SmithKline Beecham Canada has recalled Contac 12-Hour Cold Capsules there.

Get a list of some PPA Drugs:
Popular cold remedy recalled in wake of FDA warning (CBC 11/6)

Get the Advisory:
FDA ISSUES PUBLIC HEALTH WARNING ON PHENYLPROPANOLAMINE (FDA 11/6)

Relevant Links:
The Food and Drug Administration - www.fda.gov
PPA Information Page - www.fda.gov/cder/drug/infopage/ppa/default.htm