To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Warns Against Dietary Supplements Containing 'Plantain' URL: http://www.pslgroup.com/dg/2C75A.htm Doctor's Guide June 13, 1997
WASHINGTON, MD -- June 13, 1997 -- The Food and Drug Administration (FDA) is warning consumers not to purchase or ingest certain dietary supplement products containing "plantain" because the products may contain Digitalis, a plant that contains powerful heart stimulants that can cause life-threatening heart reactions including cardiac arrest if ingested. The FDA has detected Digitalis in samples of raw material labeled "plantain" that has been used by various manufacturers as an ingredient in making dietary supplement products. These products may list "plantain" as one of their ingredients on the labels, and are sold with a variety of claims. In addition, some of the suspect plantain has been distributed to retailers who sell the product in bulk for making tea or who use the product in blends of specialty teas for sale to consumers. Plantain is a perennial weed of the genus Plantago which includes more than 200 widely distributed species. It is used in herbal remedies as a laxative and in poultices. Plantain is grown commercially for use in forage mixtures and for use of its seeds in bulk laxatives and birdseed. It should not be confused with the tropical banana plant Musa paradisiaca, the fruit plantain which resembles a banana and is sold in some grocery stores. The distributors or manufacturers of bulk single ingredient plantain and trade-name products which may contain Digitalis are listed at the end of news item. The FDA advises consumers who have purchased products labeled "plantain" or suspect that a tea product from one of these retailers contains plantain to contact the retailer for assurance the product does not contain plantain received from one of the distributors listed. The effects of digitalis may include nausea, vomiting, dizziness, headache, confusion, hypotension (low blood pressure), vision disturbances and abnormal heart rate and rhythm. The FDA recently conducted an investigation after receiving information on a young woman who experienced abnormal heart rate with heart block, a potentially life-threatening condition, after consuming a dietary supplement product labeled as containing plantain. The agency's laboratory analyses confirmed the presence of lanatosides, constituents of the herbal ingredient Digitalis lanata, in samples of the raw material labeled as plantain used in the product. Digitalis lanata is one of several species of the plant genus Digitalis, one source of an active ingredient in some prescription heart medications. On May 16 the agency issued a warning to consumers against using the product associated with the adverse event -- CHOMPER -- and herbal laxative and cleansing agent distributed by Arise and Shine of Mount Shasta, Calif. Since then, other products containing Digitalis have been identified. The agency continues to investigate the mislabeling of raw material labeled as "plantain", and to work with manufacturers to identify any dietary supplement products that may contain Digitalis to ensure they are recalled from commercial channels. Consumers should read the ingredient label on dietary supplement products to see if "plantain" is listed as an ingredient. For updated information on firms and on products that may contain Digitalis, consumers may call the FDA's Consumer Hotline (1-800-FDA-4010), or access the Dietary Supplements section of the FDA "Foods" website on the FDA homepage (http://www.FDA.gov/). The lists will be updated as more products are identified, so consumers who use plantain-containing products should check regularly. Persons who have experienced adverse effects associated with the use of these products should see a doctor. Consumers and health professionals can report adverse events associated with the products to FDA's MedWatch adverse event reporting line at 1-800-FDA-1088. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.