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 | Why did the FDA issue a Public Health Advisory on phenylpropanolamine?
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|  On November 6, 2000, the U.S. Food and Drug Administration (FDA) issued a public health advisory that a common cough and cold and weight-loss medicine may increase the risk of stroke. The medicine, phenylpropanolamine (PPA), is commonly used in prescription and over-the-counter cold and cough products as a nasal decongestant and in over-the-counter weight control products.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 ). However, the FDA now requires products containing pseudoephedrine only be sold behind the counter due to the Combat Methamphetamine Epidemic Act of 2005, and most states require a drivers license to purchase. To identify whether you have products containing PPA:
Check the labels of over-the-counter products for the name "phenylpropanolamine" in the ingredients list.
Prescription products that contain PPA include Aquatab D, Bromanate DC, Codamine, Endal Expectorant, Naldecon Pediatric, PPA-GG CR, Quindal Expectorant, Statuss, and Statuss expectorant. Contact your doctor or pharmacist if you are unsure whether your prescription medicine contains 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. In 2005, the FDA proposed a rule reclassifying phenylpropanolamine as a drug that is not generally recognized as safe and effective. 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:
FDA Talk Paper: FDA Issues Public Health Warning on Phenylpropanolamine. http://fda.gov.bbs/topics/ANSWERS/ANS01051.html
Food and Drug Administration Public Health Advisory. Subject: Safety of Phenylpropanolamine. http://www.fda.gov/cder/drug/infopage/ppa/advisory.htm. Last accessed 11/6/2006.
This answer prepared 11/7/2000.
This information updated 1/23/2007.
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