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ASPIRIN AND NSAID WARNING LABEL FOR G-I BLEEDING IN ALCOHOLIC POPULATION

This article was originally published in The Tan Sheet

Executive Summary

ASPIRIN AND NSAID WARNING LABEL FOR G-I BLEEDING IN ALCOHOLIC POPULATION will be the subject of a Nonprescription Drugs Advisory Committee meeting before the end of the year, FDA Office of OTC Drugs Director Michael Weintraub, MD, said at a June 29 meeting of the advisory committee. In voting to add a liver toxicity warning on acetaminophen packaging directed at alcoholics (see preceding story), the advisory committee also asked FDA to postpone putting such a warning into effect until the panel can consider whether an alcohol warning is appropriate for aspirin, ibuprofen and other potential OTC nonsteroidal anti-inflammatory agents. The advisory committee was concerned that requiring an acetaminophen hepatotoxicity warning might lead consumers who imbibe alcohol to switch to aspirin and ibuprofen, which may pose a higher safety risk for that patient population given the association of those products with gastric bleeding. Committee member Alan Sinaiko, MD, University of Minnesota Medical School, said he was concerned "that there clearly are risks with the other analgesics and, while [the committee was] not given specific information . . . about that, it came up for obvious reasons." He declared that "it would be a mistake for this committee to put [the issue] aside without having some commitment from the FDA to bring it back to us within a reasonable period of time so that this all can be issued at the same time." Sinaiko added: "I would personally not like to go home tonight and hear on the news that there's a problem with one of these agents [acetaminophen] and nothing is [going to be done] with the others." Weintraub told the committee to "rest assured" that a meeting to address the gastric bleeding risks among alcohol users taking aspirin or other NSAIDs would be scheduled by the end of the current calendar year. "I think we can be pretty certain that in this year you can address [the issue of gastrointestinal bleeding with aspirin and NSAIDs]," Weintraub said. He noted that the Office of OTC Drugs will need "to get our materials ready, to get the materials we would need to provide [to the committee], [and] to inform our colleagues in the industry . . . to get ready for the discussion." He added: "When we work out the timing we'll communicate it to [the committee] as soon as possible." The committee had tentatively scheduled meetings for the first week in September to discuss a potential Rx-to-OTC switch candidate and in December on an undisclosed topic prior to the panel's request to review the gastrointestinal bleeding issue. The sole committee vote against the motion to require an acetaminophen warning and to review aspirin and NSAID G-I bleeding in alcoholics was cast by committee member Thomas Petty, MD, Presbyterian St. Luke's Medical Center in Denver, who said he did not like the "linkage" issue. "I don't know how other linkages might come up but I'm very worried about setting a precedent that one decision leads to another," Petty said. "It seems to me that if we can decide whether there is sufficient evidence that acetaminophen causes liver toxicity in alcoholics, we [either] have a warning or not." Committee member Louis Cantilena, MD/PhD, Uniformed Services University of Health Sciences, who suggested evaluating other analgesic ingredients prior to implementing a warning statement for acetaminophen, said the "linkage [is] something that was not intended." He explained that "the only reason for suggesting a linkage and asking that it occur in a timely manner is so that we wouldn't run the risk of doing harm." Cantilena said the committee's intent is to avoid pushing people "towards a more dangerous interaction." Weintraub pointed out that "anything . . . put together [by FDA] for labeling language would have to go through the notice and comment process . . . which would delay the implementation [of an acetaminophen warning label] somewhat." The FDAer indicated that the agency could delay implementation long enough to also implement all of the analgesic warnings simultaneously if the committee also decides that warnings for aspirin and ibuprofen are warranted. The concern that alcoholics might be persuaded by the proposed warning to switch from acetaminophen to other OTC analgesics, which may pose a greater risk, was raised by several committee members during the meeting and was underscored in presentations by McNeil representatives during the open public hearing portion of the meeting. "Given the rarity of the event and the far more common health risk associated with concomitant use of alcohol and alternative OTC analgesics," McNeil Executive Medical Director Anthony Temple, MD, suggested that requiring a "warning for acetaminophen would be contrary to the public health interest." He noted that alcohol also interacts with aspirin and with other NSAIDs to potentiate the risk of gastrointestinal bleeding and that the company uncovered "300 cases of aspirin- or ibuprofen-related G-I bleeds in alcohol users from a very limited number of centers around the U.S." in "only three months." McNeil, which markets Tylenol, reportedly included the reports in a submission to FDA just prior to the advisory committee. Temple maintained that "the alcoholic and particularly the social drinker are at substantially greater risk from this interaction than is the chronic alcoholic at risk from the acetaminophen interaction." Commenting on the committee recommendation, Johnson & Johnson stated: "While we continue to believe that the available scientific data do not warrant a warning for acetaminophen products, we are pleased that the advisory committee concluded that any warning should not be implemented until the risk of gastrointestinal bleeding caused by aspirin or ibuprofen when used with alcohol has been addressed." Whitehall Labs Senior Director of Medical Affairs Sandy Furey, MD/PhD, said the company was "pleased" with the committee's recommendation concerning acetaminophen and is "very confident . . . that the data will demonstrate that alcohol use is not a concern with the OTC use of ibuprofen." Whitehall, which markets Advil brand of ibuprofen as well as a number of aspirin products, raised the issue of acetaminophen-related hepatotoxicity in alcoholics in a submission to FDA in December 1989.
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