MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems and errors in the use of human medical products, including drugs and medical devices. The FDA uses this information to monitor emerging problems with treatments that have already been approved and marketed. MedWatch reports alert the FDA of serious adverse effects that were not suspected or were considered to be rare before the treatment was marketed. In some cases the MedWatch data is used to require new warning labels or even complete removal of a product from the market.

If you think you or someone in your family has experienced a serious reaction to a medical product, you can ask your pharmacist or your doctor to file a MedWatch report. However medical professionals are not required to file a report, even if you ask them to do so.

To make sure a report is filed, you can fill it out yourself. Use the consumer's Online Reporting Form yourself via the internet.

You may also want to file a complaint with your State's medical disciplinary authority in case there were concerns about safety or effectiveness about which your doctor failed to inform you.

ARTICLES ABOUT MEDWATCH AND DRUG SAFETY MONITORING

Pharmacists make more reports to MedWatch than any other professional group
http://www.ashp.org/s_ashp/article_news.asp?CID=167&DID=2024&id=3186

MedWatch criticized
http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20070212/FREE/70212001/0/FRONTPAGE

The pharmaceutical industry does not like MedWatch
http://www.eyeonfda.com/eye_on_fda/2006/02/alert_on_medwat.html

The FDA is not independent enough, takes direction from drug industry
http://www.drug-injury.com/druginjurycom/2006/02/fda_drugsafety_.html

Frontline interview on the pitfalls of the adverse event monitoring system
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/etc/script.html

A guide to the FDA drug approval and safety monitoring processes
http://www.thebody.com/sfaf/spring01/monitoring.html

Drug approvals are getting rushed through the FDA too fast for safety
http://whyfiles.org/215fda/index.php?g=4.txt

When is it safe to take a new drug?
http://www.ptcommunity.com/ptjournal/fulltext/30/1/PTJ3001014.pdf