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December 26, 2001

Underreporting of Hemorrhagic Stroke Associated With Phenylpropanolamine

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;286(24):3081. doi:10.1001/jama.286.24.3075

To the Editor: Although passive surveillance systems for adverse drug event reporting are often used to detect rare, serious adverse reactions for marketed drugs, they are limited by underreporting. The extent of underreporting is unknown and may be influenced by the severity of the event, the specialty of the reporter, how long the drug has been on the market, whether the event is labeled, and whether the drug is prescription or nonprescription.1 We attempted to assess the degree of underreporting of hemorrhagic stroke associated with phenylpropanolamine, a nonprescription drug.

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