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Phenylpropanolamine and stroke: the study, the FDA ruling, the implications
1College of Pharmacy, Ferris State University, Grand Rapids, Michigan, USA.
Cleveland Clinic Journal of Medicine
|March 27, 2001
Summary
Phenylpropanolamine (PPA) in diet aids is linked to hemorrhagic stroke risk. The FDA requested PPA product discontinuation, impacting numerous diet, cold, and cough remedies.
Area of Science:
- Pharmacology
- Neurology
- Public Health
Background:
- A case-control study identified a link between phenylpropanolamine (PPA) and hemorrhagic stroke.
- Phenylpropanolamine is a common ingredient in diet aids, cold, and cough remedies.
Purpose of the Study:
- To review the case-control study linking PPA to hemorrhagic stroke.
- To discuss the implications of the study findings and FDA actions for physicians.
Main Methods:
- Review of a case-control study on PPA and stroke risk.
- Analysis of the impact of FDA's request for market withdrawal.
Main Results:
- The study indicated a significant association between PPA use and hemorrhagic stroke.
- FDA requested cessation of marketing for PPA-containing products.
Conclusions:
- Physicians should be aware of the stroke risks associated with PPA.
- Reformulation or discontinuation of numerous PPA-containing medications is necessary.