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McNEIL's LOPERAMIDE RECOMMENDED FOR 48-HOUR OTC USE

Executive Summary

McNEIL's LOPERAMIDE RECOMMENDED FOR 48-HOUR OTC USE in treatment of non-specific diarrheal by FDA's Gastro-Intestinal Drugs Advisory Committee Dec. 8. The committee stipulated that standard OTC diarrheal labeling should restrict loperamide use to 48 hours and contraindicate use in patients with a temperature greater than 101 degrees F. In addition, the committee recommended that patients should consult a physician if they notice blood in their bowel movements. The product is currently marketed as an Rx drug under the tradename Imodium. Committee reviewer Johnson Thistle, MD, Mayo Medical School, noted that patients are likely to take the drug for more than two days if their diarrhea persists. He said the risks of prolonged use include toxic megacolon and prolongation or aggravation of specific bacterial colitis. He suggested that labeling also point out the potential seriousness of complications that could occur if loperamide is taken longer than two days. McNeil is proposing an initial OTC dose of 2-4 mg followed by a dose of 1-2 mg thereafter. Labeling for the prescription formulation recommends an initial dose of two 2 mg capsules or four teaspoonfuls of 1 mg/5 ml liquid. Committee Chairman Donald Wilson, MD, State University of New York/Downstate Medical Center, noted that most of the data McNeil presented involved an initial administration of 4 mg followed by 2 mg. He said only one study, involving patients with moderate diarrhea, studied the proposed 2 mg regimen with 1 mg followup dosage. The committee was divided on whether the dose should be in the 2-4 mg range or lower. Committee member James Butt, MD, Harry S. Truman Memorial Veterans Hospital, observed that in principle it is better to start at a minimum effective dose. FDA Cardio-Renal Division Director Raymond Lipicky, MD, commented that there are no loperamide dose ranging studies to determine differences between the 2 mg and 4 mg dosages. Noting that FDA has espoused minimum effective dose from time to time, Lipicky said that in a circumstance where one is striving for symptomatic relief in the minimum time possible "and there are no dose-related side effects that are obviously very limiting, I see no reason not to elect on a logical basis . . . the biggest dose that will work." Committee member Bertram Fleshler, MD, Cleveland Clinic Foundation, questioned the need for an Rx version of loperamide if the OTC formulation is safe. McNeil Consumer Products Medical Director Thomas Gates, MD, said the company feels there is a need to retain the prescription product because "we feel that the labeling will be so very, very different" than that for the OTC product. He said the OTC labeling will not mention use of the drug for chronic care. In current Rx labeling Imodium is indicated for "the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease."
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