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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.

Search FDA Safety Communications & Labeling Changes

Title Communication Type Date
Update on FDA's Ongoing Evaluation of Reports of Suicidal Thoughts or Actions in Patients Taking a Certain Type of Medicines Approved for Type 2 Diabetes and Obesity Safety Communication
FDA Labeling Change: Oral Methotrexate and Wrong Frequency Dosing Errors Labeling Change
FDA Labeling Change: Oral Anticoagulants and Clinically Significant Uterine Bleeding Labeling Change
FDA Labeling Change: Parenteral Iron Products and Risk of Severe Adverse Reactions to Pregnant Women and their Fetuses Labeling Change
FDA Labeling Change: Hydrochlorothiazide and Non-Melanoma Skin Cancer Labeling Change
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
FDA Warns that Gadolinium-Based Contrast Agents (GBCAs) are Retained in the Body; Requires New Class Warnings Labeling Change, Safety Communication
FDA Labeling Change: Etanercept (Enbrel) and Use in Pregnancy Labeling Change
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
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
FDA Approves Label Changes to Include Intestinal Problems (Sprue-Like Enteropathy) Linked to Blood Pressure Medicine Olmesartan Medoxomil Labeling Change, Safety Communication
Update on the Risk for Serious Bleeding Events with the Anticoagulant Pradaxa (Dabigatran) Safety Communication
Information on Rotarix Labeling Revision Pertaining to Intussusception Labeling Change, Safety Communication