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McNEIL AD CLAIM THAT IBUPROFEN SIDE EFFECT PROFILE IS "INDISTINGUISHABLE"

Executive Summary

McNEIL AD CLAIM THAT IBUPROFEN SIDE EFFECT PROFILE IS "INDISTINGUISHABLE" from aspirin, in cluding the likelihood of stomach upset, is being challenged by American Home Products (AHP) in a June 24 complaint filed in New York Federal Court. AHP alleges that the objective of McNeil's latest Tylenol ad campaign is to "tar the OTC ibuprefen products with the same stomach upset and other side effect safety concerns that McNeil has heretofore directed against aspirin-based analgesic products." The suit alleges that McNeil's advertising is contrary to the findings of FDA that "the safety record of ibuprofen is on a par with Tylenol's, and that, in fact, OTC ibuprofen products such as Advil would be expected to have fewer side effects than Extra-Strength Tylenol or 'extra-strength' doses of aspirin." The complaint quotes FDA's Summary Basis of Approval for OTC ibuprofen. The FDA summary said that "at 'extra strength' doses the incidence of adverse effects (applicable) to aspirin and acetaminophen would be expected to be higher" than OTC ibuprofen, AHP noted. One of the ads AHP objects to is included in a brochure for health care professionals which claims Extra-Strength Tylenol provides "superior non-Rx analgesia" and is "first-line therapy" for general aches and pains, headache, sprains and strains, musculoskeletal pain and dental pain. Under the heading "sprains and strains" the ad notes that "3.6 gm aspirin daily is needed for true anti-inflammatory effect" while "at least 1,600 mg daily of ibuprofen is required for clinical demonstrable antiinflammatory effect." The ad further states that "Extra-Strength Tylenol plus local therapy usually provides optimal pain relief." AHP contends the ad makes "the false and misleading claim that Extra-Strength Tylenol has an anti-inflammatory effect." AHP also objects to McNeil's statement that Tylenol is the analgesic of choice among hospitals. "Such advertising falsely and misleadingly represents that hospitals trust or prefer Tylenol over other acetaminophen brands, such as Anacin-3, because Tylenol is superior to those brands in safety or effectiveness." The company declares: "McNeil never informs consumers in its advertising that the reason Tylenol is chosen by hospitals over other brands of acetaminophen has nothing to do with any alleged superiority of Tylenol over other acetaminophen brands but rather the low price at which Tylenol is offered by McNeil to hospitals for purchase or other considerations unrelated to safety or effectiveness." The complaint was filed jointly by the Washington, D.C. law firm Arnold & Porter and the New York firm Parker, Auspitz, Neesemann & Delehanty. AHP is seeking preliminary injunction against dissemination of the ads described in the complaint or similar ads, an award of profits, damages, costs and attorneys' fees and an order requiring McNeil to distribute corrective advertisements.

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