Resources for You
2014 Safety Alerts for Human Medical Products
- Contact Information For Voluntary Adverse Event Reporting
- MedWatchLearn - Teaching students, health professionals, and consumers how to report problems to FDA
Medical Product Safety Educational Resources
- Consumer-Friendly Reporting Form 3500B (PDF - 1.2MB)
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.
Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch Administration of a dose lower than intended, especially in patients prone to severe electrolyte imbalance, may lead to serious, life-threatening adverse health consequences. Posted 11/21/2014 Forever Beautiful Bee Pollen by REFA Enterprises: Recall - Undeclared Drug Ingredients Risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke Posted 11/20/2014 Intravia Containers by Baxter: Recall - Particulate Matter UPDATED 11/20/2014. Recall Classified as Class I. Particles may irritate patient’s veins, cause pain, worsen a previous infection, cause allergic reactions, block blood vessels, and cause death. Originally posted 10/25/2014 Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur Failure of power supply may cause ventilator to shut off, resulting in too much carbon dioxide or not enough oxygen in patient’s blood, or death. Posted 11/19/2014 ABC Dophilus Powder by Solgar, Inc: Recall - Risk of Infection The product was found to contain Rhizopus oryzae, which may cause health problems to consumers, particularly premature infants/infants, children, and those with weakened immune systems. Posted 11/17/2014 October 2014 Safety Labeling Changes includes 37 products with revisions to Prescribing Information. Posted 11/17/2014 Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses. Posted 11/16/2014 Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall - Potential Mold Contamination There is the possibility of fungal infection should patients come in contact with the mold. Posted 11/14/2014 Mayhem: Public Notification - Undeclared Drug Ingredients Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries, and psychiatric problems. Posted 11/14/2014
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.