MedWatch

Food and Drug Administration

MedWatch is the Food and Drug Administration’s Safety Information and Adverse Event Reporting Program. MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared with the medical community or the general public. The system includes publicly available databases and online analysis tools for professionals. MedWatch also disseminates medical product safety alerts - such as recalls and other clinical safety communications - via its website, email list, Twitter, and RSS feed.

The system

MedWatch was founded in 1993 to collect data regarding adverse events in healthcare. An adverse event is any undesirable experience 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). As of the summer of 2011, the program had received more than 40,000 adverse event reports.^[1]

Voluntary reporting by healthcare professionals, consumers, and patients is conducted on a single, one-page reporting form (Form FDA 3500^[2]). Reporting can be conducted online,^[3] by phone 1-800-FDA-1088, or by submitting the MedWatch 3500 form by mail or fax 1-800-FDA-0178. In 2013, MedWatch introduced Form 3500B, which is designed to facilitate reporting by healthcare consumers.^[4] 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.^[5] and the MedWatch E-list.^[6]

Raw data from the MedWatch system, together with adverse drug reaction reports from manufacturers as required by regulation, are part of a public database.^[7] Online tools (such as those from eHealthMe) that analyze the database are available for both health care consumers and professionals.^{[8][9][10][11]} The database was used by journalists to investigate FDA's drug approval practice.^[12][13]

References

1. McKee, Jennie. "Using the FDA's MedWatch program". American Academy of Orthopaedic Surgeons. Retrieved January 15, 2014.
2. http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm082725.pdf
3. MedWatch Online Reporting Form 3500
4. "FDA's MedWatch program turns 20: What's new?". American Pharmacists Association. October 1, 2013. Retrieved January 15, 2014.
5. MedWatch Home Page
6. MedWatch - Join the MedWatch E-list
7. Adverse Event Reporting System (AERS) Database
8. Free online AERS analysis tools that can personalized to gender and age
9. Online AERS analysis Tools
10. OpenVigil free scientific AERS analysis tool (software package)
11. OpenVigil free scientific AERS analysis tool (online search engine hosted at Kiel university)
12. CBS News - Dangerous Drugs