Reporting to MedWatch is a civic duty - analogous to a "Neighborhood Crime Watch". Its main purpose is to prevent repetition of a catastrophe by making the culprit recognizable.
MedWatch is the United States" only safety network for Drug Safety after a drug is on the market.
YOU are the eyes and ears of FDA! Learn more about MedWatch - MedWatch FAQs.
You have the option .
File a report Online .
or .
Fill out a one-page form Hard Copy that you can Download here and then mail to FDA. The hard copy comes with a self-addressed, stamped envelope. .
FDA recommends filling out the form and then seeking assistance from Pharmacist and/or Physician. This is a good idea, and much better than simply requesting one's physician to make the report.
Herbal, Nutraceutical, Nutritional Supplement Adverse Event information is filed in the same way that Prescription Drug Side Effects / Adverse Events are reported.
DrugIntel recommends downloading the hard copy to get organized before starting the online version. Some information may not be available; this should not prevent you from submitting the report. However, the more complete and accurate the report, the more effective it will be. You may want to refer to Supplemental instructions for reporting.
MedWatch key links:.
MedWatch Reporting for Consumers .
MedWatch Reporting Home .
Faqs for MedWatch Reporting by DrugIntel .
Definitions of Adverse Drug Reaction - Adverse Drug Event .
Terms: MedWatch is how the following are accomplished by FDA in cooperation with the Pharmaceutical Companies in the USA: Pharmacovigilance, Spontaneous Adverse Event Reporting (AER), Serious Adverse Event Reporting (SAEr), Post-Marketing Experience. It is voluntary except for Pharmaceutical Companies fielding complaints by their Medical Affairs division, who are required to report to FDA. [Caution: There is significant flexibility in the reporting requirements. In the case of an Ethical Pharmaceutical Company, there is no difference between reporting to FDA MedWatch directly, or to the Pharmaceutical Company.
Clinicians who detect ventilator-associated pneumonia or respiratory colonization with B. cepacia associated with the use of alcohol free mouthwash have been encouraged to report such episodes through their local health departments to CDC's Hospital Infections Program, National Center for Infectious Diseases, and to MedWatch, the FDA Medical Products Reporting Program. ...
