Revision as of 16:12, 30 May 2012

MedWatch is the Food and Drug Administration’s reporting system for an adverse event (sometime also called a sentinel event), and was founded in 1993. An adverse event is any undesirable experience temporally associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems, primarily with drugs and medical devices, but also for other FDA-regulated products (e.g., dietary supplements, cosmetics, medical foods, and infant formulas). Vaccines are not covered by MedWatch, but instead entails the Vaccine Adverse Event Reporting System (VAERS). MedWatch also does not cover veterinary medicine and internet fraud.

Overview

FDA's MedWatch program offers voluntary reporting by healthcare professionals, consumers, and patients. This reporting can be conducted several different ways including a single, one-page reporting form (Form FDA 3500) tha can be mailed to the address on the form or faxed to 1-800-FDA-0178, online reporting is available at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm , or by phone at 1-800-FDA-1088.

The MedWatch system is intended to detect safety hazard signals for medical products. If a signal is detected, the FDA can issue medical product safety alerts or order product recalls, withdrawals, or labeling changes to protect the public health. Important safety information is disseminated to the medical community and the general public via the MedWatch web site at http://www.fda.gov/Safety/MedWatch/default.htm and the MedWatch E-list and texting service that can be subscribed to at https://public.govdelivery.com/accounts/USFDA/subscriber/new?pop=t&topic_id=USFDA_46

Raw data from the MedWatch system, together with adverse drug reaction reports from manufacturers as required by regulation, are part of a public database. Online tools that analyze the database are available for both health care consumers and professionals. The database is open enough that it was even used by journalists to investigate FDA's drug approval practice.

See also

Food and Drug Administration
Drug recalls
Vaccine Adverse Event Reporting System

References

1. Wikipedia, MedWatch, https://en.wikipedia.org/wiki/MedWatch
2. FDA, MedWatch Tutorial Transcript: FDA MedWatch and Patient Safety, http://www.accessdata.fda.gov/videos/MedWatch/tutorial/tutorial_transcript.htm
3. MedWatch Voluntary Reporting Form (3500)
4. MedWatch Online Voluntary Reporting Form (3500), https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
5. MedWatch Home Page, http://www.fda.gov/Safety/MedWatch/default.htm
6. Sign up for MedWatch e-list, https://public.govdelivery.com/accounts/USFDA/subscriber/new?pop=t&topic_id=USFDA_46
7. Adverse Event Reporting System (AERS) Database, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm
8. CBS News - Dangerous Drugs, http://www.ire.org/resource-center/stories/17401/