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This article was originally published in The Tan Sheet

Executive Summary

MARION MERRELL DOW RESUMES DIRECT-TO-CONSUMER PRINT ADS FOR SELDANE-D during the week of April 5. The campaign is MMD's first for the Seldane (terfenadine) family since the prescription nonsedating antihistamine was relabeled in July to warn of possible life-threatening cardiovascular side effects. The ads will run in April and May in magazines including Time, People and Better Homes and Gardens, MMD said. In the wake of the relabeling, Marion Merrell Dow has not run consumer ads while it worked out appropriate advertising language with FDA. Seldane family sales have dropped sharply in the meantime: the company reports that February prescriptions were 25% lower than in February 1992. The new print ads carry the tag line: "Finally, a medicine for my seasonal allergies that's worth seeing my doctor about." Below the Seldane-D logo is a warning: "YOU MUST NOT TAKE SELDANE-D if you are taking the antifungal drugs ketoconazole (Nizoral), itraconazole (Sporanox), the antibiotics erythromycin, clarithromycin, or troleandromycin, or if you have liver disease. DO NOT TAKE MORE THAN the amount of Seldane-D prescribed by your doctor. Seldane-D has been associated with rare occurrences of abnormal heartbeats, heart attack, and death under these conditions." In another consumer outreach program, Marion Merrell Dow announced the establishment of a "pollen hotline" April 13. The hotline gives consumers who call the toll-free number information on predicted pollen levels for their region of the country, updated weekly. After hearing the forecast, callers are reminded that OTC antihistamines have side effects, that consumers should read the warnings carefully, and that they may want to consult a physician. Callers are also given the opportunity to leave their address and phone number for more information. The consumer ads are breaking just as Schering-Plough is launching Claritin (loratadine), a new prescription nonsedating antihistamine. Claritin was approved by FDA on April 12 for treatment of allergic rhinitis. Claritin is indicated "for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis." In placebo controlled trials involving more than 10,700 patients "10 mg once daily of Claritin was superior to placebo and similar to [Sandoz' Rx-to-OTC switch Tavist] clemastine (1 mg BID) or terfenadine (60 mg BID) in effects on nasal and non-nasal symptoms of allergic rhinitis," labeling states. "In these studies somnolence occurred less frequently with Claritin than with clemastine and at about the same frequency as terfenadine or placebo," labeling states. "In studies with Claritin at doses two to four times higher than the recommended dose of 10 mg, a dose related increase in the incidence of somnolence was observed. Therefore, some patients, particularly those with hepatic or renal impairment and the elderly, may experience somnolence." Claritin labeling suggests that it is free of serious cardiovascular side effects. "In a study in which Claritin was administered at four times the clinical dose for 90 days, no clinically significant increase in the QTc was seen on ECGs," labeling states. In five years of international marketing and "more than 600 mil. patient days of use," Schering-Plough said, Claritin has "not been associated with any reports to date of torsades de pointes," the life-threatening arrhythmia seen with Seldane and J&J's Hismanal. Tachycardia has been reported with overdoses of Claritin, labeling states. Labeling states that "the number of subjects who concomitantly received macrolide antibiotics, ketoconazole, cimetidine, ranitidine or theophylline along with Claritin is too small to rule out possible drug-drug interactions." Schering-Plough has committed to "conduct interaction studies with erythromycin, ketoconazole and cimetidine," FDA's approval letter states. Schering-Plough's efforts to demonstrate that Claritin is free of the side effects seen with Seldane and Hismanal could ultimately place Claritin in a position to become the first nonsedating antihistamine to move over-the-counter in the U.S. In the wake of the relabeling of Seldane and Hismanal, however, FDA will likely proceed cautiously with any OTC switch in the class. Claritin is available OTC in 13 countries worldwide, including Canada and the U.K.

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