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ANTITUSSIVE/EXPECTORANT COMBOS: "NO RATIONALE" EXISTS FOR Rx BRONCHITIS

Executive Summary

ANTITUSSIVE/EXPECTORANT COMBOS: "NO RATIONALE" EXISTS FOR Rx BRONCHITIS combos that contain the same ingredients as OTC antitussive/expectorant combination products, FDA's Pulmonary-Allergy Drugs Advisory Committee unanimously agreed at its Oct. 22-23 meeting. FDAer John Winkler, MD, told the committee that a number of NDAs are currently pending at FDA for such combination products at Rx doses seeking a bronchitis indication. "I don't think there is any rationale for having an expectorant, number one," panel member Leslie Hendeles, PharmD, University of Florida, said. "Number two, while I think there is an important role for an antitussive in the acute self-limited cough . . . whether it be productive or nonproductive, it seems to me inappropriate to have chronic bronchitis as an indication for the product." The committee members concurred, after reviewing studies in the literature, that there is not enough information on the usefulness of antitussive/expectorant combination ingredients to rationalize their use in prescription products. On the first day of the Oct. 22-23 meeting, the committee also discussed the effect of theophylline on school performance, adverse reactions of beta-agonists, and an overview of surfactant therapy for respiratory distress syndrome. While acknowledging that theophylline may cause behavioral problems in some users of the product, the committee recommended not to change theophylline's current labeling. "There appears to be inadequate evidence that the committee should take any action or express any additional cause for concern," panel chairman Oscar Frick, MD, University of California Medical School, declared. The members recommended further clinical studies with psychological parameters and an article in the FDA Drug Bulletin. There was also a consensus on the committee not to change the labeling for beta-agonists because of a lack of evidence connecting reports of adverse reactions, from the use of bronchodilators, to the agents. However, one member suggested that the section on the potential for paradoxical bronchospasm and cardiac arrhythmias should be highlighted. Committee members also suggested that more studies be conducted and that an article on the issue appear in the FDA Drug Bulletin.
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