Hydroxycut™

Below is a report generated on generated on March 11, 2002 from a search of the The Special Nutritionals Adverse Event Monitoring System (SN/AEMS) provided for by the US Food and Drug Administration.  The information carries the following important disclaimer, as written by the Food and Drug Administration.

What do I need to keep in mind when using information from the SN/AEMS? Reporting is voluntary and the information is 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.

The SN/AEMS Web Report All Special Nutritional Products for Selected ARMS Number(s)

Important information about the SN/AEMS

Important information about using the SN/AEMS Web Report

Below are the ARMS number(s). This display includes all of the special nutritional products noted in the adverse event report for each ARMS number.

 

ARMS Number	Adverse Event as Reported	Name of Product	Manufacturer	Ingredients
13099 Note disclaimer.	Diagnosed psychosis schizophrenia	Amino Fuel	Unknown	L-carnitine, branched chain amino acid, L-alanine, L-arginine, L-aspartic acid, L-carnitine, L-cystine, glycine, L-glutamic acid, L-histidine, L-Isoleucine, L-leucine, L-lysine, L-methionine, phenylalanine, proline, L-tryptophan, PABA, others
		Diet System	Unknown	citrimax, DHEA, cola nut, guarana extract, chromium picolinate, choline bitartrate, betaine HCl, L-carnitine complex
		Goldenseal Root	Unknown	goldenseal root
		Pro RX	Unknown	vitamin C, vitamin A, vitamin D, vitamin E, thiamin, riboflavin, niacin, vitamin B6, folic acid, vitamin B12, biotin, pantothenic acid phosphorus, iodine, magnesium, zinc, copper, potassium sodium, protein, phenylalanine
		Hydroxycut	Unknown	hyroxagen, ma-huang extract, guarana extract, willow bark extract, L-carnitine, chromium picolinate
		DHEA	Unknown	DHEA

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 Special Nutritionals.

Source of reports? A variety of sources: FDA's MedWatch program, FDA's field offices, other Federal, State, and local public 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 problems associated 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 information is 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 be referenced 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 adverse event 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 ease of 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.: American Herbal Products Association, 1992). Thus, for example, "ma-huang" is hyphenated and "cola nut" is spelled with a "c" rather than 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).

Important! Synonyms are not automatically included in your searches. Therefore, searching on one particular word or term may not yield all the records of interest. Many ingredients have more than one name (e.g., vitamin C and ascorbic acid or ma-huang, ephedra, and epitonin) or spelling. Similarly, symptoms reported in the "Adverse Event as Reported" field may be recorded as abbreviations, common parlance, or medical terminology. For example, SOB, shortness of breath, and dyspnea are synonyms and would need to be entered separately in order to retrieve all of the appropriate records.

Note: See "What do I need to keep in mind when using information from SN/AEMS" above.

This page generated on 11 Mar 2002.