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FDA Safety Communications

The following table provides summary information concerning FDA safety communications issued via their MedWatch: The FDA Safety Information and Adverse Event Reporting Program. MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professionals and patients. Please click on the details link for additional information.


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Results from Assessments of FDA Safety Communications Search. Click on the title in each column header to sort based on that column; click twice to reverse the sort. By default, the list is sorted by date with newest postings first.
 TitleLinkDate Posted
DetailsUpdate: FDA Postlicensure Rapid Immunization Safety Monitoring (PRISM) study demonstrates no statistically significant association between Trivalent Inactivated Influenza Vaccine and Febrile Seizures in Children during the 2010-2011 influenza seasonhttp://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm397611.htm

DetailsFDA Safety Communication: FDA Approves Required Revised Labeling for RotaTeq Based Final Study Results of a Mini-Sentinel Postlicensure Observational Study of Rotavirus Vaccines and Intussusceptionhttp://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm356758.htm 7-22-2013
DetailsFDA Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil http://www.fda.gov/Drugs/DrugSafety/ucm359477.htm 7-03-2013
DetailsPradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Eventshttp://www.fda.gov/safety/medwatch/safetyinformation/safetyal
DetailsUpdate: Information on Rotarix- Labeling Revision Pertaining to Intussusception http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm226690.htm 9-07-2012
Page Updated: 12/18/2015