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PPA and adverse events

This article was originally published in The Tan Sheet

Executive Summary

Limitations of passive AE reporting systems underscored by findings of Hemorrhagic Stroke Project, FDAers report in research letter published in Dec. 26 JAMA. During Yale's five-year, six-state study of OTC weight loss and cough/cold drug ingredient, 27 of 702 participants who experienced stroke were exposed to PPA. "During the same period, no states or hospitals in the study area reported cases to the Adverse Event Reporting System," authors state, adding "this very low rate of passive reporting is consistent with previous estimates"...
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