Phenylpropanolamine (PPA)
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Phenylpropanolamine is an ingredient used in prescription and over-the-counter (OTC) drug products as a nasal decongestant to relieve stuffy nose or sinus congestion and in OTC weight control drug products to control appetite.
On May 11, 2000, FDA received results of a study conducted by scientists at Yale University School of Medicine that showed an increased risk of hemorrhagic stroke (bleeding of the brain) in people who were taking phenylpropanolamine. The Yale study helped show that the number of people having strokes when taking phenylpropanolamine was greater than the number of people having strokes who were not taking phenylpropanolamine. Although the risk of hemorrhagic stroke is very low, FDA has significant concerns because of the seriousness of a stroke and the inability to predict who is at risk.
- FDA Talk Paper: FDA Issues Public Health Warning on Phenylpropanolamine Nov 6, 2000
- FDA Public Health Advisory re: Safety of Phenylpropanolamine Nov 6, 2000
- Questions and Answers re: Safety of Phenylpropanolamine Nov 6, 2000
- Food and Drug Administration Science Background re: Safety of Phenylpropanolamine Nov 6, 2000
- FDA Letter to Manufacturers of Drug Products Containing Phenylpropanolamine (PPA) Nov 3, 2000
- Transcript of Nonprescription Drugs Advisory Committee Meeting on Safety Issues of Phenylpropanolamine (PPA) in Over-the-Counter Drug Products (RTF) Oct 19, 2000
- Background Documents for Nonprescription Drugs Advisory Committee Meeting on Safety Issues of Phenylpropanolamine (PPA) in Over-the-Counter Drug Products Includes prior epidemiological and statistical studies, correspondence, and consultant reviews. Oct 19, 2000
- FDA Proposes Additional Warning Label on Over-the-Counter PPA Products Feb 14, 1996
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