PPA FDA Warnings

On November 6, 2000, the Food and Drug Administration (FDA) announced a recall all products containing phenylpropanolamine (PPA) that are sold over-the-counter. The agency advised that PPA should no longer be "generally recognized as safe," a requirment for over-the-counter drugs.

The agency also requested that drug companies stop marketing products containing PPA. The agency went one step further and issued a public health advisory for phenylpropanolamine hydrochloride, the active ingredient in PPA.

PPA has been linked to a heightened risk of hemorrhagic stroke, a serious health condition marked by bleeding into the brain or into the tissue surrounding the brain. Real concern followed the release of a scientific PPA study from Yale University that found that women between the ages of 18-49 were nearly 16 times more likely to experience a stroke within the first three days of taking products containing PPA than those who did not take PPA.

The Yale PPA study used control subjects in its testing. It concluded that PPA increased the risk of stroke by 50% and found the link particularly strong for women who ingested PPA products related to appetite suppression.

Since 1979, there have been nearly 30 published case reports of brain hemorrhaging related to ingesting PPA, many of them involving the PPA found in diet pills. At least five reports, however, involved PPA in cough and cold medications.