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Nonprescription Ibuprofen Approved
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Nonprescription Ibuprofen Approved On May 18, 1984, the Food and Drug Administration approved the use of low-dose (200 mg per tablet) ibuprofen as a nonprescription product. This is the first new nonprescription pain reliever to enter the market in 29 years. FDA apparently agreed with the proponents of nonprescription status that ibuprofen could indeed be used by consumers safely without the intervention of a prescribing physician, because of the drug's excellent safety record after extensive prescription use: more than 130 million prescriptions for ibuprofen have been filled during its ten years of availability in the United States under the brand names Motrin (U pjohn) and Rufen (Boots). Nonprescription ibuprofen will be marketed as Advil by Whitehall Laboratories, Division of American Home Products Corporation, and as Nuprin, which will be manufactured by Upjohn but distributed by Bristol-Myers (which has more experience than Upjohn in marketing of this sort of nonprescription pain reliever). It is anticipated that a good deal of money will be spent in the launching of the new products . For Advil, Advertising Age estimated that $50 million will be spent in the first year to promote the product; the New York Times offers a somewhat more conservative estimate-$35 million. When the FDA Arthritis Advisory Committee met in August 1983 to consider whether a nonprescription version of ibuprofen should be marketed, members of the committee expressed some concern about the safe use of the drug-specifically, about whether users could be sufficiently warned about the high frequency of cross-reactivity between allergy to aspirin and ibuprofen (90 %). Another problem concerned the possible consequences of advertising nonprescription ibuprofen without adequate cautions about its crossreactivity. 12
But it seems that the final labeling adopted for both Advil and Nuprin is now considered by FDA to provide adequate protection for the consumer. Commented FDA's director of new drug evaluation Robert Temple: "[The labeling] alleviates a concern of the FDA Advisory Committee that helped us consider nonprescription ibuprofen. The committee recommended approval of the drug but was concerned that its promotion might encourage inappropriate use. We don't want anyone to think that this 'non-aspirin' pain reliever can be safely taken by people with aspirin allergy." The adopted labeling therefore features a boldface warning about aspirin sensitivity at the beginning of the statement: "Do not take this product if you have had a severe allergic reaction to aspirin, e. g., asthma, swelling, shock or hives, because even though this product contains no aspirin or salicylates, cross-reactions may occur in patients allergic to aspirin." There is also a warning about potential teratogenicity included, in capital letters: "It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed by a doctor because it may cause problems in the unborn child or complications
during delivery." Indications of the new product are for "the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, for the minor pain of arthritis, for the pain of menstrual cramps, and for reduction of fever." In its press release on Advil, Whitehall reinforces the warning statement in the labeling by suggesting that "people who have had a severe allergic reaction to aspirin or any other pain reliever should consult a doctor before taking Advil," and adds that "consumers are urged to read the full labeling and take caution to use the product according to directions." And on its part, Bristol Myers plans an extensive professional ad campaign, to alert those in the health care fields about the availability of nonprescription ibuprofen and the potential problems that patients may experience with it. Ibuprofen was first discovered in the early 1960s by Stewart Adams of The Boots Company in the United Kingdom. In mid-1983, ibuprofen was granted nonprescription status in that nation. Since that time, it has achieved widespread use among consumers looking for an alternative to aspirin and acetaminophen.
American Pharmacy Vol. NS24, No.7, July
19B414~
Nonprescription Ibuprofen Approved On May 18, 1984, the Food and Drug Administration approved the use of low-dose (200 mg per tablet) ibuprofen as a nonprescription product. This is the first new nonprescription pain reliever to enter the market in 29 years. FDA apparently agreed with the proponents of nonprescription status that ibuprofen could indeed be used by consumers safely without the intervention of a prescribing physician, because of the drug's excellent safety record after extensive prescription use: more than 130 million prescriptions for ibuprofen have been filled during its ten years of availability in the United States under the brand names Motrin (U pjohn) and Rufen (Boots). Nonprescription ibuprofen will be marketed as Advil by Whitehall Laboratories, Division of American Home Products Corporation, and as Nuprin, which will be manufactured by Upjohn but distributed by Bristol-Myers (which has more experience than Upjohn in marketing of this sort of nonprescription pain reliever). It is anticipated that a good deal of money will be spent in the launching of the new products . For Advil, Advertising Age estimated that $50 million will be spent in the first year to promote the product; the New York Times offers a somewhat more conservative estimate-$35 million. When the FDA Arthritis Advisory Committee met in August 1983 to consider whether a nonprescription version of ibuprofen should be marketed, members of the committee expressed some concern about the safe use of the drug-specifically, about whether users could be sufficiently warned about the high frequency of cross-reactivity between allergy to aspirin and ibuprofen (90 %). Another problem concerned the possible consequences of advertising nonprescription ibuprofen without adequate cautions about its crossreactivity. 12
But it seems that the final labeling adopted for both Advil and Nuprin is now considered by FDA to provide adequate protection for the consumer. Commented FDA's director of new drug evaluation Robert Temple: "[The labeling] alleviates a concern of the FDA Advisory Committee that helped us consider nonprescription ibuprofen. The committee recommended approval of the drug but was concerned that its promotion might encourage inappropriate use. We don't want anyone to think that this 'non-aspirin' pain reliever can be safely taken by people with aspirin allergy." The adopted labeling therefore features a boldface warning about aspirin sensitivity at the beginning of the statement: "Do not take this product if you have had a severe allergic reaction to aspirin, e. g., asthma, swelling, shock or hives, because even though this product contains no aspirin or salicylates, cross-reactions may occur in patients allergic to aspirin." There is also a warning about potential teratogenicity included, in capital letters: "It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed by a doctor because it may cause problems in the unborn child or complications
during delivery." Indications of the new product are for "the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, for the minor pain of arthritis, for the pain of menstrual cramps, and for reduction of fever." In its press release on Advil, Whitehall reinforces the warning statement in the labeling by suggesting that "people who have had a severe allergic reaction to aspirin or any other pain reliever should consult a doctor before taking Advil," and adds that "consumers are urged to read the full labeling and take caution to use the product according to directions." And on its part, Bristol Myers plans an extensive professional ad campaign, to alert those in the health care fields about the availability of nonprescription ibuprofen and the potential problems that patients may experience with it. Ibuprofen was first discovered in the early 1960s by Stewart Adams of The Boots Company in the United Kingdom. In mid-1983, ibuprofen was granted nonprescription status in that nation. Since that time, it has achieved widespread use among consumers looking for an alternative to aspirin and acetaminophen.
American Pharmacy Vol. NS24, No.7, July
19B414~