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Search results for "Governmental Reporting"
- Governmental Reporting
- Side Effects/Adverse Drug Reactions
Tools/Toolkit > Fact Sheet/FAQs
FDA Consumer Health Information. Silver Spring, MD: US Food and Drug Administration; February 27, 2009.
This fact sheet provides information for consumers about how to report adverse drug events and product complaints to the US Food and Drug Administration (FDA) through the Consumer Complaint Reporting system and MedWatch.
Journal Article > Study
Serious adverse drug events reported to the FDA: analysis of the FDA Adverse Event Reporting System 2006–2014 database.
Sonawane KB, Cheng N, Hansen RA. J Manag Care Spec Pharm. 2018;24:682-690.
This retrospective study reviewed serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration between 2006 and 2014. Over the 9-year study period, the number of serious ADEs reported doubled and a small number of medications accounted for a significant number of serious and fatal ADEs.