Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Symbiq Infusion System by Hospira: FDA Safety Communication - Cybersecurity Vulnerabilities The device could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies. Posted... 0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences. Posted 07/31/2015 Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor). Posted 07/30/2015 Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected. Posted... Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use Health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary. Posted 07/27/2015 Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. Posted 07/24/2015 0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs. Posted 07/20/2015 Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns Monitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions. Posted 07/16/2015 Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models UPDATED 07/15/2015- Recall classified by FDA as Class I. Health care providers and facilities should immediately stop using the recalled tubes and use alternatives instead. Originally posted 06/24/2015 Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration Notice to health care providers- please check inventory and crash boxes and remove affected Calcium Chloride Intravenous Infusion subject to market withdrawal. Posted 07/14/2015 June 2015 Safety Labeling Changes includes 30 products with revisions to Prescribing Information. Posted 07/14/2015 Lariat Suture Delivery Device for Left Atrial Appendage (LAA) Closure by SentreHEART: FDA Safety Communication - Reports of Patient Deaths and Other Serious Adverse Events Safety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established. Posted 07/13/2015
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.