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SELDANE REVISED LABELING AND PATIENT INFORMATION PROGRAM DELAYED

Executive Summary

SELDANE REVISED LABELING AND PATIENT INFORMATION PROGRAM DELAYED by the Sept. 11 approval of Janssen's antifungal Sporanox (see preceding T&G). Dissemination of new Seldane labeling and advertising is being held up while Marion Merrell Dow adds Sporanox (itraconazole) into the list of drugs that have potentially fatal interactions with the prescription antihistamine product terfenadine. FDA and MMD are understood to have reached final agreement on Seldane relabeling at the beginning of September. However, the requirement to include itraconazole interactions in the Seldane label could set back the patient information program several weeks, if not longer. The company had been planning to run ads at the start of the autumn cold and allergy season. Negotiations between FDA and MMD over Seldane labeling changes and direct-to-consumer advertising already have lasted two months. The agency announced on July 7 that boxed warnings would be added to Seldane labeling contraindicating against concomitant use of ketoconazole (Janssen's Nizoral) and erythromycin due to reports of serious cardiovascular events, including death ("The Pink Sheet" July 13, p. 9). To disseminate the contraindication information immediately, FDA issued a press release warning of the serious potential drug interaction side effects. MMD announced that it would undertake a consumer information program that would include patient pamphlets and unit-of-use packaging to be distributed in physicians' offices and pharmacies. In addition, MMD said it planned to highlight the contraindications in direct-to-consumer advertising. At the time of the announcement, MMD sent 900,000 letters to doctors and other health professionals warning against the use of Seldane and ketoconazole or erythromycin.
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