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POLYCARBOPHIL CATEGORY I STATUS TO BE REVERSED BY FDA because

This article was originally published in The Tan Sheet

Executive Summary

POLYCARBOPHIL CATEGORY I STATUS TO BE REVERSED BY FDA because "data are lacking to support the OTC use of calcium polycarbophil and polycarbophil for acute nonspecific diarrhea," the agency told the Nonprescription Drug Manufacturers Association in a Sept. 14 letter. FDA Monograph Review Staff Director William Gilbertson said that the OTC office intends "to recommend to the [FDA] commissioner that the agency reverse its tentative decision that calcium polycarbophil and polycarbophil be considered Category I" (safe and effective). In the letter, FDA also denied NDMA's request to defer action on attapulgite in the upcoming antidiarrheal final monograph. Along with attapulgite, polycarbophil and calcium polycarbophil were the only ingredients classified as Category I in FDA's April 1986 tentative final monograph for OTC antidiarrheal drug products. Calcium polycarbophil is also used as a bulk-forming laxative in several OTC products such as Ciba's Fiberall and Lederle's FiberCon, and polycarbophil is used as a component of Columbia Labs' Replens vaginal moisturizer. FDA's "detailed review and evaluation on calcium polycarbophil and polycarbophil" will be discussed in a future feedback letter to the industry, Gilbertson said. "In the interim," he suggested that NDMA or its member companies submit additional data on calcium polycarbophil or polycarbophil "in the form of a petition to reopen the administrative record for this rulemaking." FDA decided to re-evaluate the data on calcium polycarbophil and polycarbophil as a result of an April joint meeting of FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees on the safety and efficacy of the antidiarrheal ingredients attapulgite and kaolin/pectin. At that meeting, the committees determined that the data available did not support the effectiveness of attapulgite, and narrowly voted in favor of kaolin's efficacy ("The Tan Sheet" April 12, p. 1). "Based on some of the issues raised by the advisory committees and our own reviewers, we have found it necessary to re-review the data submitted and other available data on calcium polycarbophil and polycarbophil" and reverse the decision to place the two ingredients in Category I, Gilbertson told NDMA. "Only two of the studies" relied on by the OTC advisory panel in the 1970s to support a Category I determination for polycarbophil "involve patients with acute nonspecific diarrhea," Gilbertson said. These studies, which compare calcium polycarbophil and kaolin-pectin, "were conducted in a population in which the majority (88%-92%) of subjects were less than five years old," he noted. Moreover, Gilbertson said, "a placebo control was not used in either of the studies and the comparative or study drug had not been shown to have effectiveness at the time of the trial." Gilbertson declared that FDA does "not believe that these data can be extrapolated to an adult population having acute nonspecific diarrhea." Also, "questions have arisen as to whether one study is simply an add-on to the other," he said, and "data irregularities between the publications raise other questions about the acceptability of these studies." At present, "the agency is aware of no other data on calcium polycarbophil or polycarbophil to support its use for acute nonspecific diarrhea," the FDAer concluded.

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