FDA Safety Communications

The following table provides summary information concerning FDA safety communications based on Sentinel activities issued via FDA’s 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 patients and healthcare professionals.

Title Date Postedsort ascending
FDA Safety Communication: FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis 03/04/2020
FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings 12/19/2017
Update: 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 season 05/16/2014
FDA Safety Communication: FDA Approves Required Revised Labeling for RotaTeq Based Final Study Results of a Mini-Sentinel Postlicensure Observational Study of Rotavirus Vaccines and Intussusception 07/22/2013
FDA Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil 07/03/2013
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events 10/31/2012
Update: Information on Rotarix- Labeling Revision Pertaining to Intussusception 09/04/2012