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FDA Safety Communications & Labeling Changes

The following table provides summary information concerning FDA safety communications issued via FDA’s MedWatch: The FDA Safety Information and Adverse Event Reporting Program, and safety-related labeling changes, based on Sentinel activities.

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Title Communication Type Date
FDA Labeling Change: Oral Methotrexate and Wrong Frequency Dosing Errors Labeling Change 12/17/2021
FDA Labeling Change: Oral Anticoagulants and Clinically Significant Uterine Bleeding Labeling Change 01/28/2021
FDA Labeling Change: Parenteral Iron Products and Risk of Severe Adverse Reactions to Pregnant Women and their Fetuses Labeling Change 09/11/2020
FDA Labeling Change: Hydrochlorothiazide and Non-Melanoma Skin Cancer Labeling Change 08/20/2020
FDA Requires Boxed Warning about Serious Mental Health Side Effects for Asthma and Allergy Drug Montelukast (Singulair); Advises Restricting Use for Allergic Rhinitis Labeling Change, Safety Communication 03/03/2020
FDA Warns that Gadolinium-Based Contrast Agents (GBCAs) are Retained in the Body; Requires New Class Warnings Labeling Change, Safety Communication 12/19/2017
FDA Labeling Change: Etanercept (Enbrel) and Use in Pregnancy Labeling Change 07/11/2017
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 Safety Communication 05/16/2014
FDA Approves Required Revised Labeling for RotaTeq Based Final Study Results of a Mini-Sentinel Postlicensure Observational Study of Rotavirus Vaccines and Intussusception Labeling Change, Safety Communication 07/22/2013
FDA Approves Label Changes to Include Intestinal Problems (Sprue-Like Enteropathy) Linked to Blood Pressure Medicine Olmesartan Medoxomil Labeling Change, Safety Communication 07/03/2013
Update on the Risk for Serious Bleeding Events with the Anticoagulant Pradaxa (Dabigatran) Safety Communication 10/31/2012
Information on Rotarix Labeling Revision Pertaining to Intussusception Labeling Change, Safety Communication 09/04/2012