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.

Search FDA Safety Communications & Labeling Changes

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