Tools for Life - US FDA Medwatch Program
The U.S. Food and Drug Administration (FDA) has the responsibility for
assuring the safety and efficacy of all regulated marketed medical products
in the United States.
MedWatch, The FDA Safety Information and Adverse Event Reporting Program,
serves both healthcare professionals and the medical product-using public.
MedWatch - Home Page
Medwatch - Safety Information
- Consumers - How To Report
MedWatch - form 3500 for reporting to the FDA (pdf file)
- MedWatch provides important and timely clinical information about
safety issues involving medical products, including prescription and
over-the-counter drugs, biologics, medical and radiation-emitting devices,
and special nutritional products (e.g., medical foods, dietary supplements
and infant formulas).
- MedWatch provides medical product safety alerts, recalls, withdrawals,
and important labeling changes that may affect the health of all Americans
via the web site and the MedWatch E-list. Select "Safety Information" on
the MedWatch website to see reports, safety notifications, and labeling
changes posted to the website since 1996.
- MedWatch allows healthcare professionals and consumers to report
serious problems that they suspect are associated with the drugs and
medical devices they prescribe, dispense, or use.
- Reporting can be done on
line, by phone, or by submitting the MedWatch 3500 form (PDF file) by mail or fax.
Select "How to Report" on the MedWatch website for more details.
Report adverse experiences with:
- Medications (drugs or biologics)
- Medical devices (including in-vitro diagnostics)
- Special nutritional products (dietary supplements, medical foods,
- Medication errors
Report product problems - quality, performance or safety concerns such
- Suspected counterfeit product
- Suspected contamination
- Questionable stability
- Defective components
- Poor packaging or labeling
- Therapeutic failures
Report SERIOUS adverse events. An event is serious when the patient
- Death Life-threatening (real risk of dying)
- Hospitalization (initial or prolonged)
- Disability (significant, persistent or permanent)
- Congenital anomaly
- Required intervention to prevent permanent impairment or damage
Report even if:
- You're not certain the product caused the event
- You don't have all the details