Medwatch, dietary supplements

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. ... 

Table 2 Dietary Supplement Information from MedWatch for Herbal Products from 1999-2003... 

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). 

Although laws do not require reporting of adverse events of dietary supplements to the FDA at this time, many untoward events have been documented. The FDA has created MEDWATCH [(800) FDA-1088] to receive and compile reports of adverse reactions from pharmaceuticals. Healthcare providers are encouraged to report to this organization any and all adverse events related to dietary supplements and their consumption. 

Food and Drug Administration (1999a). Important message for health professionals - Report of serious adverse events associated with dietary supplements containing GBL, GHB or 1,4BD. FDA website http //www.fda.gov/medwatch/safety/1999/gblghb.htm. 

More than 50 reports regarding herbal products, including efficacy concerns and serious adverse effects, have been reported to the DPPR (Anonymous, 1999a). Health care professionals may also contact the FDA s MedWatch program at 1-800-FDA-1088 with reports of serious adverse effects involving herbal products, other dietary supplements, or drugs. 

Currently, there are no mandated US federal guidelines to report adverse events or consumer health complaints associated with the use of dietary supplements. MedWatch reporting is voluntary. In 2004, the Life Sciences Research Office published a report. Recommendations for Adverse Event Monitoring Programs for Dietary Supplements. 

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