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IMODIUM A-D ORAL REHYDRATION DIRECTIONS IN LABELING

This article was originally published in The Tan Sheet

Executive Summary

IMODIUM A-D ORAL REHYDRATION DIRECTIONS IN LABELING are appropriate, McNeil asserted in an April 5 letter to FDA. The communication responds to a March 9 letter from the World Health Organization that, according to McNeil, "claims that McNeil Consumer Products and our affiliate Janssen Phamaceutica inappropriately communicate the role of our over-the-counter and prescription brands of loperamide for the treatment of diarrhea relative to the role of oral rehydration therapy" ("The Tan Sheet" March 29, p. 5). Janssen markets prescription loperamide, Imodium, while McNeil markets the OTC formulation, Imodium A-D. Calling the WHO assertions "incorrect and unfounded," McNeil maintained that "it is well-recognized" that oral rehydration therapy "may be necessary in patients suffering from diarrhea" and should be the "first line of therapy in children with diarrhea." Both McNeil and Janssen "communicate this position with respect to appropriate use of their antidiarrheal products," the Johnson & Johnson subsidiary contended. McNeil noted that Imodium A-D labeling states: "Drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea." The company said its statement is "reinforced in our communications to physicians." McNeil also pointed out that Imodium A-D labeling "limits the consumer use of the product to children ages six years and above." For children under the age of six, the consumer is directed to consult a physician. Labeling contains no dosing directions for "infants and young children," the company reported. The WHO letter to FDA Commissioner David Kessler was sent in support of a petition submitted by Public Citizen's Health Research Group that seeks the market withdrawal of a number of OTC and prescription antidiarrheal products including pediatric and liquid formulations of loperamide. Expressing concern "over the widespread use of ineffective and often dangerous antidiarrheal drugs in young children," the letter specifically criticizes J&J for promoting its products "as adjuncts to oral rehydration therapy." McNeil also defended WHO's challenge of a statement made by the company in a July 1992 letter to the Medical Lobby for Appropriate Marketing that stated: "It has been standard practice by physicians in the U.S. to use rehydration initially and then to use oral antidiarrheal medications as appropriate." WHO had argued that "a review of current pediatric textbooks failed to find any that advocate the use of antidiarrheal agents . . . for the routine management of diarrhea." In response, McNeil's letter cites the current edition of Text of Pediatric Gastroenterology, which states that: "Recent reports have indicated that loperamide hydrochloride or bismuth subsalicylate are of benefit in their treatment of mild to moderate diarrhea." To further support its statements on physician practices, McNeil said it "conducted a survey of 100 physicians to assess their practice attitudes in treating diarrhea" that found that "the most frequently used methods for treating diarrhea in children ages two to five were improved diet (61%) and rehydration (59%)." Treatments used most often in children aged six and older "were improved diet (65%) and rehydration (58%)." The letter does not report how many physicians surveyed used antidiarrheal agents to treat children. However, the survey did find that 66% of the physicians surveyed "considered it appropriate to use antidiarrheals to treat patients in this group." In addition to WHO, FDA has received letters from other organizations supporting the HRG petition. Recent letters from the Harvard School of Public Health, Brown University's International Health Institute and the Columbia, Md.- based International Child Health Foundation echo WHO's concerns regarding oral rehydration therapy taking a back seat to antidiarrheal agents for the treatment of pediatric diarrhea. ORT "treats the dehydration of diarrhea by replacing water and electrolytes, whereas these drugs have no significant effect on the severity or duration of diarrhea or on fluid and electrolyte loss," Richard Cash, MD, Harvard School of Public Health, asserted in an April 6 letter to FDA. Cash also charged that the marketing approaches of loperamide manufacturers are "misleading" in this regard.
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