Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Programmable Syringe Pumps: FDA Safety Communication - Problems With Fluid Flow Continuity at Low Infusion Rates Reports of serious clinical consequences, such as over- and under- infusion of high risk or life-sustaining medications, occlusion detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other malfunctions. Posted 08/25/2016 Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination Klebsiella pneumoniae contamination, if present in the product, may result in infections that may be sight-threatening. Posted 08/22/2016 Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter Administered of metal particulate may result in serious adverse events such as stroke, heart attack, respiratory failure, kidney failure, or liver failure. Posted 08/19/2016 Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution by Arbor Pharmaceuticals: Recall - Inadequate Seal of Blister Pack Risk of sub-therapeutic dose as well as potential microbial contamination. Posted 08/18/2016 Comfort Shield Barrier Cream Cloths by Sage Products: Recall - Product Contamination UPDATED 8/16/2016. Recall expanded to include an additional lot. Product with B. cepacia may cause serious, life-threatening infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups....
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.