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Why did the FDA issue a Public Health Advisory on phenylpropanolamine?

A recent study reported that PPA might increase the risk of hemorrhagic stroke (bleeding in the brain). Although the risk appears to be very low, the FDA recommends that consumers not use any products that contain PPA. If you or someone in your family is taking a product that contains PPA, the FDA recommends that you discuss alternative medicines with your health care provider. Nasal decongestants that do not contain PPA include pseudoephedrine (brand name Sudafed) and phenylephrine (>Dristan Multisymptom Nasal Decongestant ).

To identify whether you have products containing PPA:

The FDA has taken the additional step of requesting manufacturers of drugs containing PPA to remove them from the market voluntarily. While no pharmacies have received such a request, drugstore.com has decided to take additional action on its own. It is important to us that the products you purchase from drugstore.com are safe. Effective immediately, drugstore.com no longer sells over-the-counter products that contain PPA.

You can learn more about the FDA Public Health Advisory through the FDA Web site, here:
http://www.fda.gov/cder/drug/infopage/ppa/advisory.htm

Sources:
Food and Drug Administration Public Health Advisory. Subject: Safety of Phenylpropanolamine. http://www.fda.gov/cder/drug/infopage/ppa/advisory.htm. Last accessed 11/6/00.
FDA Talk Paper: FDA Issues Public Health Warning on Phenylpropanolamine. http://fda.gov.bbs/topics/ANSWERS/ANS01051.html

This answer prepared 11/7/00.

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