# The Special Nutritionals Adverse Event Monitoring System



## JeanG (Oct 20, 1999)

This is an interesting site to do searches on nutritional supplements and herbs to see if any adverse reactions have been reported. I've only copied part of it, and not the search engine, because it would have been too long. Now you can check that vitamin or herb you've wondered about. The URL for the article is: http://vm.cfsan.fda.gov/~dms/aems.html U. S. Food and Drug AdministrationCenter for Food Safety and Applied NutritionOffice of Special Nutritionals The Special Nutritionals Adverse Event Monitoring System The Special Nutritionals Adverse Event Monitoring System (SN/AEMS) What is it? Adverse event (illness or injury) reports associated with use of a special nutritional product: dietary supplements,infant formulas, and medical foods. When did it start? The SN/AEMS was established in early 1993 following the establishment of the Office of SpecialNutritionals. Source of reports? A variety of sources: FDA's MedWatch program, FDA's field offices, other Federal, State, and localpublic health agencies, letters and phone calls from consumers and health professionals. What are adverse event monitoring systems? These serve as warnings for identifying emerging public health problemsassociated with use of marketed products: Adverse event monitoring systems are designed to identify unanticipated or unintended safety problems with use of marketed products. Patterns of adverse events help FDA identify the need for further investigation to determine whether public health actions are needed. What do I need to keep in mind when using information from the SN/AEMS? Reporting is voluntary and the informationis as reported by the consumer or health care professional. This means that: Only adverse events reported to FDA will be in the SN/AEMS. If an event occurred but is not reported to FDA, it will not be in the database. Absence of information does not necessarily mean a particular product or ingredient has not been or is not likely to be associated with an adverse event. There is no certainty that a reported adverse event can be attributed to a particular product or ingredient. The available information may not be complete enough to make this determination. The total number of adverse events cannot be used to estimate the rate of occurrence in the population. Not all adverse events are reported, and there are no reliable data on population use patterns. Reporting of an adverse event may be affected by many factors, including length of time a product or ingredient has been marketed or publicity. Comparisons of the safety of one product versus another cannot be directly obtained from these data. The available information may not be complete enough to make this comparison. The inclusion of a product as a special nutritional in the SN/AEMS does NOT necessarily represent its legal/regulatory status. The available information may not be complete enough to make this determination. How do I report an adverse event? Go to the MedWatch page for additional information and instructions. USING THE SPECIAL NUTRITIONALS ADVERSE EVENT MONITORING SYSTEM (SN/AEMS) WEB REPORT Important! Initially, information in the SN/AEMS may be incomplete. As additional information becomes available, SN/AEMS is updated. The column headings in the SN/AEMS Web Report are: ARMS Number: The unique identification number assigned to each adverse event report. The ARMS number should bereferenced in all requests for additional information (Freedom of Information Request). Adverse Event As Reported, usually by the consumer or health professional. The text is as supplied or stated in the adverseevent report except when the reporter's language is long or complex. Then, it may have been paraphrased or abbreviated.Quotation marks indicate the exact word(s) used by the reporter in the adverse event report. Name of Product*: The name of the product(s) as identified in the adverse event report. Manufacturer*: The name of the manufacturer of the product(s) as identified in the adverse event report. Ingredients*: The ingredients in the product(s) either as listed on the label or as reported in the adverse event report. For easeof searching, all ingredient spellings have been standardized. For botanical ingredients, the spellings have been standardized,when possible, according to those used in the publication Herbs of Commerce (Foster S, ed. Bethesda, Md.: AmericanHerbal Products Association, 1992). Thus, for example, "ma-huang" is hyphenated and "cola nut" is spelled with a "c" ratherthan a "k" (kola nut). * "unspecified" or "unknown" are used to indicate information that was not provided. "?" is used in any field to indicate that information was provided, but that it was illegible due to poor copy quality or poor handwriting. "others" is used in the "Ingredients" field to indicate that information exceeds the field capacity (250 characters). YOU MAY EITHER BROWSE OR SEARCH THE SN/AEMS WEB REPORT. Browsing the SN/AEMS Web Report


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## kitty2 (Nov 27, 1999)

Wow - thanks for the link Jean! I encourage everyone to check out this site. I typed in "glutamine" and some of the reports ended in death! Although the ones that ended in death had lots of other ingredients in the product and you cannnot know if it was linked to the product.


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## Mike NoLomotil (Jun 6, 2000)

Thanks for the Post, Jean. Since the Food Borne Illness Division of the local FDA office seems reticent to speak to consumers made ill, perhaps I can follow this path to enlightenment.Thanks.MNL


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## JeanG (Oct 20, 1999)

Bump!


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## cookies4marilyn (Jun 30, 2000)

Thanks Jean....this is very helpful







------------------"Cookies" alias Marilyn


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## Krissy (Jul 6, 2000)

wow Jean,i have been on the herbal route for a while,that is a REALLY great site!You've done it again







Krissy


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## Guest (Aug 11, 2000)

Great post, Jean







Julie


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## JeanG (Oct 20, 1999)

bump


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