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This article was originally published in The Tan Sheet

Executive Summary

H[2] BLOCKER INTERACTION WITH ALCOHOL IS "NOT CLINICALLY SIGNIFICANT," FDA's Gastrointestinal Drugs Advisory Committee concluded on March 12. Committee member Arvey Rogers, MD, University of Miami, said that "based on the data that has been presented to us . . . there is no apparent clinical or social significance" to the elevations of blood alcohol levels for patients who have taken approved H[2] antagonists. By a vote of five to one, the committee agreed with Rogers. An additional four members voted by proxy that there was no clinically significant effect. However, FDA is concerned with the effect of H[2] blockers on alcohol blood levels and whether the issue should be reflected in professional labeling for the prescription products. Assuming that any of the H[2] antagonists are switched to OTC, FDA also will have to consider possible consumer labeling for the alcohol interaction. OTC switch applications are pending at FDA for SmithKline Beecham's Tagamet (cimetidine) and Merck's Pepcid (famotidine). Glaxo's Zantac (ranitidine) and Lilly's Axid (nizatidine) are being pursued as OTC versions as well. Although the committee did not consider the increases clinically significant, a majority agreed that increased blood alcohol levels were "consistently" demonstrated with patients who had taken three of the ulcer drugs: Axid, Tagamet and Zantac. "Even the sponsors' own studies have demonstrated significance," committee member Ralph D'Agostino, PhD, Boston University, said. "It is at a very low level [.15 g/kg of alcohol] and it is under very strict conditions: fed, healthy male nondrinkers" who were tested in the morning. Several members noted that there were more data available for Zantac and Tagamet than for Axid. While a majority of the committee felt that Merck's Pepcid had not been "consistently" shown to interact with alcohol, the group voted unanimously that no H[2] blocker, including Pepcid, had been shown conclusively to have no effect on blood alcohol levels. The discussion of the prescription H[2] antagonists also may have some bearing on FDA's concern with the effect of aspirin on blood alcohol levels. That issue was briefly alluded to by FDA Gastrointestinal and Coagulation Drug Products Division Director Stephen Fredd, MD, during the advisory committee meeting. FDA has asked the industry for information regarding the effect of aspirin on alcohol absorption in correspondence that began last summer. Recently, in a Jan. 28 letter to the Nonprescription Drug Manufacturers Association, FDA noted that "a significant interaction between these two commonly available substances would be important to mention in aspirin product labeling." FDA is expected to meet with NDMA and the Aspirin Foundation to discuss the combination of alcohol and aspirin and its affects on blood alcohol levels in the near future, although a date has not yet been set. The question of whether to address possible alcohol interactions in product labeling for all prescription and OTC drugs was raised by committee consultant and former member Stephen Hanauer, MD, University of Chicago. Hanauer noted that "there are many factors that affect alcohol and alcohol levels" and that if the committee is going to be "currently concerned about this we're going to have to re-examine every single prescription and over- the-counter medication on its potential effect of alcohol function." FDA's Fredd indicated that the agency currently is interested in only a few product categories where there may be a clinically significant interaction with alcohol, noting that FDA is "interested in aspirin and intends to ask the Aspirin Foundation for further studies." The committee considered possible statements to incorporate the data in professional labeling, although no consensus emerged. On the basis of the discussion, Fredd said he did not "sense at this point any urgency about" changing the label. "I really get a sense of discomfort from the committee of making a labeling change at this time," Fredd said, adding that he also felt "a sense of discomfort at saying" that no labeling change will ever be warranted. Fredd suggested that the committee could address the labeling issue again "perhaps a year from now." In the meantime, he said, FDA "will work . . . to try to get data to help answer" the committee's questions. The committee asked for data comparing drug to placebo within individuals of various ages to determine if there were any people for whom an H[2] blocker could cause a clinically significant change in psychomotor performance. Committee member Helen Shields, MD, Beth Israel Hospital, Boston, expressed concern that there may be "unusual and rare patients" for whom the slight increase in alcohol concentrations "might make a difference." Shields was the one committee member who voted that the interaction is clinically significant. Representatives of Glaxo and SmithKline Beecham told the committee that they would be willing to perform a psychomotor study if it meant that no labeling change would be made at this time. A representative from Merck demurred, noting the company's position that Pepcid already has been shown not to have the effects seen with other H[2] blockers.

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