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OTC LOPERAMIDE, LOMOTIL PEDIATRIC USE BAN REQUESTED BY PUBLIC CITIZEN

Executive Summary

OTC LOPERAMIDE, LOMOTIL PEDIATRIC USE BAN REQUESTED BY PUBLIC CITIZEN in a citizen's petition submitted to FDA on Jan. 7. In addition, the petition calls for halting sales of OTC and prescription antidiarrheal products containing kaolin and pectin, activated charcoal and attapulgite. Public Citizen cites a 1990 World Health Organization report on management of acute diarrhea in children and a recent report by the Centers for Disease Control in arguing that the products are "ineffective,...may be dangerous and even fatal to children," and discourage the use of oral hydration solution (ORS). The petition specifically seeks "a ban on all pediatric formulations of loperamide hydrochloride," including liquid formulations of J&J's prescription Imodium and OTC Imodium-AD, P&G's Pepto Diarrhea Control solution, and all generic versions. In addition, the petition requests "a ban on pediatric prescription formulations of diphenoxylate HCl with atropine sulfate," specifically citing Searle's liquid formulation of Lomotil and generic versions. Quoting the WHO report, the petition maintains that "the ultimate test of antidiarrheal efficacy is the extent to which the drug checks the loss of fluids and electrolytes; thus it is also essential to measure stool weight or stool volume in clinical trials, and not merely to report on a change in stool appearance or consistency." On this basis, the consumer group questions the efficacy of all six active ingredients. Public Citizen also asks FDA to relabel "all adult antidiarrheal preparations" (i.e. solid oral dosage forms) of diphenoxylate/atropine sulfate and loperamide to include a boxed warning and a contraindication in children. The boxed warning, Public Citizen asserts, should alert "doctors and parents to (1) the great number of severe gastrointestinal and central nervous system side effects reported with diphenoxylate/atropine sulfate and loperamide; and (2) the lack of evidence of efficacy [of the two products] in reducing the rate of fluid and electrolyte loss in children." The petition asks FDA to send out a "Dear Doctor/Pharmacist" letter in the interim. The letter, Public Citizen says, should notify recipients "of the ineffectiveness and/or detrimental effects of these drugs in children and adults." In the petition, Public Citizen quotes the WHO report,"The Rational Use of Drugs in the Management of Acute Diarrhea in Children," stating: "Antidiarrheal drugs should never be used. None has any proven value and some are dangerous." Public Citizen points out that "at least ten" developing countries have already banned or relabeled "some or all of the drugs addressed" in the petition in response to the WHO report. The petition also points to CDC's Oct. 16, 1992 Recommendations and Reports on the management of acute diarrhea in children. CDC noted that "the use of nonspecific antidiarrheal agents such as adsorbents (e.g. kaolin-pectin), antimotility agents (e.g. loperamide), antisecretory drugs, or toxin binders (e.g. cholestyramine) is a common practice in many developed and developing countries." The report adds that "despite the theoretical benefits from their use, available data do not demonstrate their effectiveness in reducing diarrhea volume or duration." CDC concluded that "little evidence exists to support the use of nonspecific drug therapy in children, and much information exists to the contrary." Public Citizen seeks a ban of all pediatric and adult formulations of products containing kaolin and pectin, activated charcoal, and attapulgite. Kaolin/pectin and activated charcoal were put in Category III (lack of safety and/or effectiveness data) during FDA's OTC panel review of ingredients and continue to be marketed with that regulatory status under the agency's tentative final monograph for OTC antidiarrheal products published in April 1986. The petition cites the WHO report in questioning the efficacy of these ingredients. Attapulgite (Pfizer's Rheaban, Upjohn's Kaopectate) was reclassified from Category III to Category I (safe and effective) in the TFM based on a placebo-controlled study submitted by Pfizer. The petition maintains that the "failure to measure stool volume or weight (in addition to number of stools) [in the study] precludes any assessment of the drug's efficacy in preventing dehydration." The Nonprescription Drug Manufacturers Association pointed out that OTC antidiarrheal products are not recommended for children under three years of age and that the CDC has identified the first year of life as the most vulnerable to diarrhea. "The labeling recommended by FDA for these OTC products thus ensures a margin of safety well beyond the critical year of vulnerability identified by CDC," NDMA maintained. A J&J spokesperson noted that "no data" have been reported in the U.S. since loperamide was switched to OTC that suggests that use of the product in recommended doses "is associated with any significant risks in children or adults." He pointed out that labeling for Imodium-AD only covers children aged six or older and recommends that consumers consult with a physician before administering the drug to children under five.
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