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This article was originally published in The Tan Sheet

Executive Summary

ANTIDIARRHEAL INGREDIENTS ATTAPULGITE, KAOLIN/PECTIN SAFETY AND EFFICACY will be discussed by FDA's Nonprescription Drugs Advisory Committee during the second day of its April 8-9 meeting. As part of its deliberations, the committee is expected to comment on portions of a petition submitted by Public Citizen's Health Research Group on Jan. 7 that seek a ban of all antidiarrheal products containing kaolin and pectin, activated charcoal and attapulgite. The advisory committee also is expected to discuss the role of oral rehydration solutions in the treatment of diarrhea. Kaolin and pectin were placed in Category III (safety and efficacy data insufficient to permit classification) by FDA in an April 1986 tentative final monograph for OTC antidiarrheal products. Attapulgite -- found in Pfizer's Rheaban, Upjohn's Kaopectate, Columbia's Diasorb and A. H. Robins Consumer's Donnagel products -- was reclassified from Category III to Category I (safe and effective) in the TFM after Pfizer submitted a placebo-controlled study supporting the ingredient's use. HRG believes the antidiarrheal ingredients should be taken off the market based on the findings of two reports on the management of acute diarrhea in children: a 1990 report by the World Health Organization and an October 1992 report by the Centers for Disease Control and Prevention. HRG noted that both documents questioned the efficacy of the antidiarrheal agents and encouraged the use of oral rehydration solution. The WHO study concluded that "kaolin and pectin cannot be recommended for the treatment of diarrhea, and there is thus no rationale for the production and sale of products that contain these agents," HRG pointed out. Regarding attapulgite, WHO said that it has "no place in the management of acute diarrhea in children and should not be used," according to HRG. The consumer advocacy group also criticized the Pfizer attapulgite data, arguing that the "failure to measure stool volume or weight (in addition to number of stools)" in the Pfizer study "precludes any assessment of the drug's efficacy in preventing dehydration." The HRG petition also calls for a ban of all pediatric loperamide products, including liquid formulations of Johnson & Johnson's Imodium prescription product and Imodium A-D OTC brand, Procter & Gamble's Pepto Diarrhea Control solution and all generic versions. The committee is not slated to address loperamide; however, the issue may come up during committee discussion, FDA said. Although attapulgite, kaolin and pectin, activated charcoal and loperamide are all marketed over-the-counter, HRG argued, "there has never been any convincing evidence of their effectiveness in reducing the fluid and electrolyte losses associated with" diarrhea. "By contrast, management of diarrhea with [oral rehydration solution] is considered one of the most important medical advances of this century," HRG maintained. "ORS is a simple, low-cost, and easily attainable method to prevent or correct" dehydration that accompanies diarrhea. Discussion of antidiarrheals will follow advisory committee consideration of caffeine as an OTC analgesic adjuvant on April 8. A new nonvoting member may be representing the industry at the April 8-9 session of the advisory committee. The Nonprescription Drug Manufacturers Association nominated former Norcliff-Thayer exec Paul Roberts, MD, to the committee in February following the resignation of the panel's first industry rep, Clairol VP-Research Edward Marlowe ("The Tan Sheet" March 1, p. 2). FDA currently is awaiting official endorsements for Roberts from other trade associations that would be affected by the advisory committee's recommendations, such as the Cosmetic, Toiletry and Fragrance Association, the Council for Responsible Nutrition, the European-American Phytomedicines Coalition, and the International Pharmaceutical Excipients Council of the Americas, before officially accepting Roberts' nomination.

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