MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Posted 01/23/2015 Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication - Reports of Serious Injuries Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling. Posted 01/21/2015 December 2014 Safety Labeling Changes includes 72 products with revisions to Prescribing Information. Posted 01/15/2015 Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products. Posted 1/14/2015 IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients UPDATED 01/10/2015 Wallcur Practi-IV solutions bags are recalled. Originally posted 12/30/2014. Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy Pregnant women urged to discuss all medicines with their health care professionals before using them. Posted 01/09/2015
FDA Approved Safety Information
DailyMed (National Library of Medicine)
Current Drug Prescribing Information. (NOTE: Drugs marked "unapproved" on this site have not been reviewed by FDA for safety and efficacy, and their labeling has not been approved.)
Paper handouts that come with many prescription medicines. Medication Guides address issues specific to particular drugs and drug classes. They contain FDA-approved information that can help patients avoid serious adverse events.
Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.