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ALCOHOL WARNINGS FOR OTC ASPIRIN, IBUPROFEN AND NAPROXEN RECOMMENDED

This article was originally published in The Tan Sheet

Executive Summary

ALCOHOL WARNINGS FOR OTC ASPIRIN, IBUPROFEN AND NAPROXEN RECOMMENDED to inform consumers about a potentially increased risk of gastrointestinal bleeding by FDA's Nonprescription Drugs and Arthritis Advisory Committees on Sept. 8. The committees voted 12- 2 in favor of an aspirin warning label; 12-2 in favor of an ibuprofen warning label; and 11-1 (with two abstentions) in support of a warning label for naproxen should FDA approve Syntex/Procter & Gamble's switch application for the drug. After a review of more than 30 published and unpublished studies on aspirin-, non-steroidal anti-inflammatory drug (NSAID)- and alcohol-related G-I bleeding, the joint committee concluded that heavy drinking could increase the risk of aspirin-associated bleeding episodes. While the committee voted to extend the labeling to ibuprofen, several committee members were skeptical that the data showed an association between alcohol-related G-1 bleeding and the drug. The naproxen warning label was not extensively debated. Nonprescription Drugs Advisory Committee Chairman Randy Juhl, PhD, University of Pittsburgh, suggested that the committee had "a responsibility to help the public use the drugs better, however we interpret that." "The trend is quite clear that the consumer expects more information on all of the health care issues and the drugs being monographed," Juhl said. "The question we have to answer is: Can we help, not necessarily the entire public, but the population we can protect with the warning?" If the answer is yes, Juhl added, "then we ought to take that action." Nonprescription Drugs Advisory Committee member Alan Sinaiko, MD, University of Minnesota, urged the group not to resist recommending a warning in the absence of "absolute data." Simply because "no one has acted on this [before], or we haven't seen thousands of case reports, doesn't necessarily mean that there's not a problem," Sinaiko maintained. "To pretend that we don't want to do something today because there's no science just begs the question of how much you'd rather have." He asserted that some OTC analgesics -- particularly aspirin -- had safety profiles which would have prevented them from receiving approval today. Responding to concerns about labeling ibuprofen products given the absence of supporting data, Sinaiko argued that "it is impossible to qualify this [analgesic warning] in such a way that we don't create an enormous imbalance" in consumer use patterns by exempting ibuprofen. "I'm worried that that will happen, and that the consequences will be worse than what we have now," Sinaiko told the group. Instead, he advocated labeling all OTC aspirin and NSAID products with a universal alcohol interaction warning. The committee decided to address the question of aspirin and NSAID warning labels after it recommended in June that acetaminophen products carry a label warning on potential liver toxicity risk for heavy drinkers ("The Tan Sheet" July 5, pp. 1- 8). Tylenol marketer McNeil urged the committee in June to investigate whether heavy drinkers switching to other analgesics were placing themselves at greater risk for other adverse events, such as G-1 bleeding. Arthritis Committee Chair Peter Lachenbruch, PhD, UCLA, argued against requiring warning labels since the data did not show that the combined risk for G-1 bleeding with the OTC analgesics and alcohol was anything but additive. He asserted that "there is no synergistic effect" in the combination. "Would you be comfortable saying that there is an excess risk using alcohol, or do you point to the joint research?" Lachenbruch asked the group. "These studies that we have seen have not said that there is an increased risk due to the joint use over the separate use of these things. Alcohol by itself increases the risk [for G-1 bleeding], but does it increase the risk above and beyond the simple effect that you've added a certain amount of alcohol? The epidemiological studies do not suggest that," he added. Calling the warning label "a public health issue," Nonprescription Drugs Advisory Committee member Elisa Lee, PhD, University of Oklahoma, disagreed with Lachenbruch. She said she believed that the combined risk was in fact higher than the individual risk to the consumer, but added that the issue was not "whether it's an interaction or not." Instead, she maintained that "it is the responsibility of this committee to inform the consumer." Other committee members concurred with Lee, saying that they felt the committee was compelled to make a conservative decision. "With all these multiple studies showing the issue from many different angles, it seems to give the impression -- and none of [the studies] are perfect -- that there is some danger here, there is some risk here," Maria Chanco Turner, MD, National Institutes of Health, said. In voting for the warning, Turner said she "would err . . . on the side of the consumer rather than not doing anything about it." FDA also asked the committee to make a recommendation on placing alcohol warnings on other salicylate analgesics, including carbaspirin calcium, choline salicylate, magnesium salicylate and sodium salicylate. However, given that no data were presented on those compounds during the meeting, the committee decided to defer consideration of the issue.
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