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Executive Summary

OTC ANALGESIC/STIMULANT COMBINATIONS FOR HANGOVER RELIEF are being proposed by FDA for inclusion in the OTC Internal Analgesic, Antipyretic, and Antirheumatic Drugs Tentative Final Monograph and the OTC Stimulant Drugs Final Monograph. Appropriately enough, FDA issued Federal Register notices on Christmas Eve, establishing the conditions under which OTC drugs are recognized as safe and effective for relief of hangover symptoms and overindulgence symptoms. As far as FDA is aware, the notice says, the only marketed analgesic/stimulant combinations for treatment of hangover contain aspirin and/or acetaminophen and caffeine. Such combination products include Whitehall's Anacin and Maximum Strength Anacin, and Bristol-Myers Squibb's Excedrin Extra Strength and Aspirin Free Excedrin. For the labeling of analgesic/stimulant combinations FDA proposes to include the following indications: "For the temporary relief of minor aches and pain associated with a hangover" and "Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover." Although FDA's proposal allows companies to make claims that their analgesic/caffeine products relieve hangover symptoms, it does not permit claims that caffeine is effective as an analgesic adjuvant. Caffeine as an adjuvant is Category III in the analgesic TFM. Products for relief of hangover symptoms encompass ingredients covered in three different rulemakings, the analgesic, stimulant and antacid monographs. FDA is proposing to amend those rulemakings to establish conditions for relief of hangover symptoms instead of establishing a separate monograph for those ingredients. FDA is reversing the Advisory Review Panel on OTC Miscellaneous Internal Drug Products' Category I recommendation for hangover products that contain an antacid ingredient and caffeine, a stimulant ingredient, stipulating instead Category II. There are only a few antacid/caffeine combinations on the market,including Dr. Seltzer's Hangover Helper. "In view of caffeine's documented effect in stimulating gastric secretions, the agency does not believe that combination products containing both caffeine, which stimulates hydrochloric acid secretion, and an antacid, which reduces the concentration of hydrochloric acid and treats the symptoms associated with high levels of hydrochloric acid, are rational," FDA said. The agency is also amending the labeling for analgesic/antacid combinations "to include a claim for relief of symptoms of hangover and a claim for relief of symptoms of overindulgence in food and drink." The following warning is proposed for analgesic/antacid combinations labeled for relief of hangover symptoms: "Do not use for more than 2 days for a hangover unless directed by a doctor." FDA issued a TFM to cover ingredients in overindulgence relief products,such as bismuth subsalicylate, that are not addressed in the other rulemakings. The TFM noted that the agency had previously determined that "fructose or any other ingredient intended to minimize or prevent inebriation is a new drug and is required to be a subject of an [NDA] before marketing." The only ingredient to be reviewed for reducing hangover, activated charcoal, remains in Category III, since no additional data were submitted to prove its effectiveness. The overindulgence TFM adds that in response to the October 1982 advance notice of proposed rulemaking, one comment requested that the claims "fast relief" and "speedy relief" be allowed in labeling of products containing sodium citrate and sodium acetylsalicylate solution. FDA decided to place these claims in Category III until further supporting data is provided. Miles' Alka-Seltzer effervescent antacid and pain reliever products contain sodium citrate and sodium acetylsalicylate.

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