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McNEIL TYLENOL HEADACHE PLUS "STOMACH UPSET" CLAIMS

Executive Summary

McNEIL TYLENOL HEADACHE PLUS "STOMACH UPSET" CLAIMS are cited by FDA in a Nov. 9 warning letter to the firm. Noting that FDA does not consider a symptom described as "upset stomach" to be an "acceptable, unqualified indication for OTC antacid drug products," the agency declares that labeling for the Extra Strength Tylenol Headache Plus acetaminophenantacid combination product is not in conformance with the final OTC drug monograph for antacids. FDA also said that the product is misbranded, because its labeling suggests that "there is substantial scientific evidence to establish that the product is safe and effective for the treatment of upset stomach as an unqualified symptom." The agency pointed out that the final monograph for OTC antacid drug products permits labeling to include an "optional claim for the relief of 'upset stomach.' However, the upset stomach claim must be qualified by appearing in the indications statement after one or more of the permitted OTC antacid indications, e.g., 'For the relief of heartburn, sour stomach, and/or acid indigestion and upset stomach associated with these symptoms.'" McNeil's packaging and promotional literature for Extra Strength Tylenol Plus, FDA indicated in the warning letter, do not qualify the "stomach upset" claim in accordance with the monograph. FDA also objects to McNeil's claim for "relief of stress headache." According to the letter, FDA cautioned McNeil representatives during an earlier meeting that the claim would cause the product, "as formulated and labeled," to be considered a daytime sedative. The agency noted that "there are no ingredients that can be generally recognized as safe and effective for use as OTC daytime sedatives." Due to the product's daytime sedative claims and nonconformity with the final OTC drug monograph for antacids, FDA concluded that Extra Strength Tylenol Headache Plus is a new drug requiring an approved NDA. In addition, the agency said that "statements in the labeling for Extra Strength Tylenol Headache Plus caplets, which represent and suggest that the drug is useful for the 'relief of stress headache plus stomach upset' are not acceptable since neither claim is allowed under the marketing provisions for such products." FDA published a notice in the Feb. 5, 1992 Federal Register allowing OTC marketing of acetaminophen and antacid combination drug products in solid oral dosage forms pending an amendment to the OTC antacid drugs final monograph ("The Pink Sheet" Feb. 17, In Brief). The notice stipulates, however, that acetaminophen-antacid products must be labeled in strict conformance with the existing final monograph for OTC antacids and the tentative final monograph for OTC internal analgesics/antipyretics. FDA reminded McNeil in the warning letter that, during the meeting between McNeil and agency reps, the company was told that "any deviation from the interim marketing order would be at risk of regulatory action." McNeil has 15 working days within receipt of the warning letter to respond regarding what actions the company "will take to discontinue the marketing of this drug or otherwise bring it into compliance." * McNeil introduced Extra Strength Tylenol Headache Plus caplets (acetaminophen 500 mg and calcium carbonate 250 mg) in September as the first product to provide "both a pain reliever and antacid in a caplet form" ("The Pink Sheet" Sept. 14, In Brief). Since then, Bristol-Myers Squibb launched its acetaminophen/antacid combination product, Aspirin Free Excedrin Dual. Excedrin Dual caplets contain acetaminophen 500 mg, calcium carbonate 111 mg, magnesium carbonate 64 mg and magnesium oxide 30 mg, and are available in packages of 24, 50, and 100. Bristol-Myers Squibb's ad agency is LCF&L of New York City.
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