MedWatch system

Sharpe, R. (1998). MedWatch system comes under fire. Wall Street Journal, June 24, 1988, p. B5. 

When medicines are on the market, the actual incidence of serious ADRs is difficult to judge but clearly they occur with sufficient frequency to be a serious concern. An authoritative review7 concludes that between 1 in 30 and 1 in 60 physician consultations result from ADRs (representing 1 in 30 to 40 patients). The same review concludes that 4 to 6% of hospital admissions could be the result of ADRs. Although there is debate over the number of deaths caused by ADRs — the figure of around 106,000 deaths per year in the USA is often quoted,2 8 this has been suggested to be a gross overestimate and, for example, the U.S. FDA MedWatch system recorded 6894 deaths in 2000 (http //www.fda.gov/medwatch/ index.html). 

Despite important progress in evaluating adverse drug reactions, there is still no reliable method to identify potential delayed events that might occur well after the original course of therapy. For example Medwatch system did not detect the identification of diethyl stilbesterol (DES) associated clear-cell adenocarcinoma in female fetuses exposed in utero [3]. 

Patients should always start with the lowest recommended dose and increase slowly to avoid overdosing. Follow-up with the patient is necessary to evaluate whether the dietary supplement is safe and effective. Report any suspected adverse event to FDA s Medwatch, 1-800-FDA-1088. FDA has developed the Special Nutritionals Adverse Event Monitoring System (SN/AEMS), a database of adverse events associated with the use of special nutritional products dietary supplements, infant formulas, and medical foods. ... 

In any case, injection site responses (erythemia, edema, pain, and tenderness) and systemic responses are both evaluated in subjects (Mathieu, 1997). USFDA also has specific guidance on the tracking and reporting of adverse clinical responses to vaccines. Any adverse events or product problems with vaccines should not be sent to MedWatch but to the Vaccine Adverse Event Reporting System (VAERA), operated jointly by FDA and the national Centers for Disease Control and Prevention. For a copy of the VAERS form, call 1-800-822-7967, or download the form (in PDF format) from www.fda.gov/cber/vaers/vaersl.pdf on FDA s Website. 

Vaccine Adverse Event Reporting System (VAERS) form. For drugs and therapeutic biologies, the MedWatch (3500A) form replaces the 1639 reporting form. 

Wysowski DK, Green L. Serious adverse events in Norplant users reported to the Food and Drug Administration s MedWatch Spontaneous Reporting System. Obstet Gynecol 1995 85(4) 538-42. 

MedWatch program. The FDA recently established the Special Nutritionals Adverse Event Monitoring System, a searchable database including information about suspected adverse events associated with dietary supplements or nutritional products. This database includes reports that have been submitted to MedWatch and can be accessed via the Internet (http //vm.cfsan.fda.gov/ dms/ aems.html). Continued efforts by health-care professionals to recognize and report suspected interactions between prescription medications and herbal and other alternative therapies should ultimately increase knowledge and awareness of interactions and improve the quality of patient care (see Heck et al., 2000 Izzo, 2004 Butterweck, 2004 Chan, 2005). 

Breggin, P.R. Review of Behavioral Effects of Benzodiazepines with an Appendix on Drawing Scientific Conclusions from the FDA s Spontaneous Reporting System (MedWatch). In Brain Disabling Treatments in Psychiatry Drugs, Electroshock and the Role of the FDA. New York Springer Publishing, 1997. 

By 1969, the FDA developed a systematic approach to collecting and maintaining adverse drug reactions after marketing. For many years, it was called the SRS. The regulations were updated in 1985, and the system has been renamed MedWatch (for the basic regulations, see Johnson... 

In describing the impact of the MedWatch spontaneous reporting system (SRS), the FDA s Kessler (1993) said ... 

Additional advantages of spontaneous reporting systems include the detection of extremely rare ADRs and ability to identify at-risk subgroups. In order to enhance the spontaneous reporting system approach, the FDA developed the MedWatch form. This form can be faxed to the agency (1-800-FDA-1078) or called in (l-800-FDA-1088). ° The forms also can be... 

Information received through the MedWatch program is entered into the Adverse Event Reporting System (AERS) database. The AERS database is designed to permit electronic or paper submission of reports, comply with international standards and terminology, and facilitate pharmacovigilance screening. In addition to the... 

MedWatch program, the FDA runs a program for adverse events related to veterinary products and in conjunction with the Center for Disease Control and Prevention, a program for adverse events with vaccines, the Vaccine Adverse Event Reports System (VAERS). 

MEDWATCH MedWatch Adverse Experience (Event) Reporting System (3500A)... 

Healthcare professionals may report ADRs by telephone 1800 FDA 1088 Fax 800 FDA 0178 or maU Med Watch, 5600 Fishers Lane, Rockville, MD 20852-9787or through the Medwatch internet site www.fda.gov/ medwatch. Medwatch provides feedback to healthcare professionals though the FDA Medical Bulletin and the Medwatch home page (www.fda.gov/ medwatch). In Europe and other countries individual Ministries of Medicine may have a system in place such as Irelands yellow card system. One might also contact The World... 

Because nearly 70% of patients who use alternative therapies do not inform their health-care providers about these products, pharmacists and other health-care professionals should question all patients about their use of alternative therapies. Health-care professionals should remain vigilant for potential interactions between alternative therapies and prescription medications, especially medications with a narrow therapeutic index, and should report suspected interactions to the FDA MedWatch program. The FDA recently established the Special Nutritionals Adverse Event Monitoring System, a searchable database including information about... 

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