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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.

Methods

We compared the number of cases of hemorrhagic stroke associated with phenylpropanolamine detected in the Hemorrhagic Stroke Project² with those reported during the same period to the Adverse Event Reporting System of the US Food and Drug Administration (FDA). The Hemorrhagic Stroke Project study was conducted between December 1994 and July 1999 in Connecticut, Massachusetts, Ohio, Kentucky, Rhode Island, and Texas. . . . [Full Text of this Article]

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