From Rx-wiki

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.


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) that can be mailed to the address on the form or faxed to 1-800-FDA-0178, online reporting is available at , 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 and the MedWatch E-list and texting service that can be subscribed to at

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.


Before David Kessler, former FDA Commissioner, introduced MedWatch in 1993 there was not a simple mechanism in place for healthcare professionals to report adverse events associated with medications or devices directly to the FDA. Many facilities and drug manufacturers had their own complicated forms along with the FDA having separate forms for drug reactions, drug quality products problems, device quality product problems, and adverse reactions to medical devices creating a patchwork of reporting tools that were largely ignored. This was despite the post marketing surveillance required of all FDA approved medications.

Various studies conducted in the 1980's suggested that 3 to 11% of admissions could be attributed to adverse drug events and yet only about 1% of adverse events were being reported to the FDA. This means that out of 1400 hospital admissions approximately 100 would be related to adverse drug events and yet only 1 was actually being reported.

MedWatch was intended to simplify this process and the FDA was also trying to actively engage physicians, hospitals, and schools involved in health care education to use this new voluntary system. MedWatch encourages health care professionals to regard reporting as a fundamental professional and public health responsibility.

Why is adverse event reporting needed?

Many health care professionals and their patients do not know that in approving medical products, including medications, biologics and devices, for sale and use that FDA does not develop or test the products itself. FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective.

Because FDA's review is based on a relatively small number of users, and because variations in quality can happen in manufacturing, FDA keeps careful watch on reports of adverse experiences with products after they are marketed. If this monitoring turns up a problem that needs to be corrected, FDA can take timely actions to improve the safety of the product.

The FDA's role postmarketing surveillance when it is monitoring for safety, is a critical one because of the limitations of pre-marketing review and the controlled clinical trials used to prove the effectiveness of the product before it is approved by FDA.

For example, the reliance of FDA and the manufacturer on the controlled clinical trial to demonstrate the efficacy of a drug for its intended use in a controlled population during NDA approval is of great use. It can be determined with some certainty that the product is effective when compared with placebo and the common serious adverse reactions will be identified. But, limitations such as number of participants and subject characteristics results in uncertainties about the safety of the pharmaceutical once it is marketed and used in a wider population, over longer periods of time, in patients with co-morbidities and concomitant medications and for 'off-label' uses not previously evaluated. This is a weakness of the clinical trial as a safety identification process. Therefore, the true picture of product safety actually evolves over the years that make up a product's lifetime in the marketplace.

How MedWatch works

The FDA is interested in receiving three types of reports, first those involving suspected serious adverse events associated with drugs, either prescription or OTC, biologic products, medical devices, cosmetics and special nutritional products such as dietary supplements, medical foods and infant formulas. Second, reports, especially from pharmacists and nurses of product quality problems that might suggest manufacturing or other quality problems with drugs or devices. In addition, FDA is very interested in reports of suspected counterfeit products. Third, reports of medication and device use errors, for example, the wrong drug/wrong dose errors that may be caused by either product name confusion or confusion resulting from packaging and labeling.

This reporting can be conducted several different ways including a single, one-page reporting form (Form FDA 3500) that can be mailed to the address on the form or faxed to 1-800-FDA-0178, online reporting is available at , or by phone at 1-800-FDA-1088. The four core elements of the report include: a reporter's name, a suspect drug or device product a narrative report of the adverse event or problem and an identifiable patient. The FDA, however, holds the identity of patients in strict confidence, protected by federal law and regulation

Patients are encouraged to take this form to their health care professional so that the report contains more detailed information when received by FDA; however, patients may submit reports directly to FDA.

Voluntary versus mandatory reporting

Often, there is a lot of concern over MedWatch's voluntary reporting, as opposed to implementing a mandatory adverse event reporting provision. The challenge would be enforcing such a provision. For a program to be mandatory there would have to be a penalty involved with noncompliance, the the FDA is concerned that penalizing individuals might deter participation rather than increase it.

An example of MedWatch's effectiveness

The story of the drug Depakote (divalproex sodium) illustrates that even after twenty years of use, new information that will improve the safe use of a medical product will be detected with the help of voluntary reports from health professionals.

In July 2000, FDA added new safety information, a black boxed warning, for Depakote after receiving multiple reports of a serious adverse event, pancreatitis, in patients taking the drug. Although the condition was listed as a possible adverse reaction when first approved in 1978, the severity of this serious condition was found to be much greater when used more widely for newer and common indications such as migraines, depression, and seizures. It was with this increased use that spontaneous reports began to be received at the FDA through it MedWatch program, prompting the new warnings to inform doctors and patients of this risk.

Even after twenty years, new information that will impact the clinical use of a medical product can be detected. Consequently, all medical products need to be continually assessed for safety.

See also

Food and Drug Administration
Five rights
Medication errors
Drug recalls
Vaccine Adverse Event Reporting System
Tallman lettering
High-alert medications
Barcoding technologies
Medication safety


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