June 1996

Dear Health Care Professional:

In two recent publications in the Journal of the American Medical Association (JAMA), the concomitant use of Seldane^® (terfenadine) products and contraindicated drugs was revisited. These studies suggest that concomitant use of Seldane/Seldane-D^® and macrolide antibiotics or azole antifungal agents still exists. We at Hoechst Marion Roussel, Inc. want to ensure that all health professionals and their patients are aware of how to use Seldane/Seldane-D appropriately. Please be reminded that Seldane/Seldane-D is contraindicated in patients taking ketoconazole, itraconazole, erythromycin, clarithromycin or troleandomycin, or in patients with significant hepatic dysfunction. In addition, the recommended daily dose of Seldane/Seldane-D should not be exceeded. The concomitant use of Seldane/Seldane-D with the macrolide antibiotics or azole antifungals, use in patients with significant hepatic dysfunction, or overdosage may result in serious cardiovascular events, including death, cardiac arrest, torsades de pointes and other ventricular arrhythmias.

Hoechst Marion Roussel, Inc. continues to be concerned that no patients be put at risk by use of Seldane/Seldane-D in conjunction with any contraindicated prescription medication. We maintain our commitment to all patients and health care providers by conducting ongoing initiatives to ensure that all of our products are prescribed and used appropriately. Since 1990, the company has cautioned physicians, pharmacists and patients about the potential for drug interactions in certain patients taking Seldane/Seldane-D. These efforts include distributing 1.2 million "Dear Doctor" letters to practicing physicians in the United States since August 1990, and adding warning labels to all Seldane/Seldane-D products since October 1992. In addition, since 1992, the company continues to support extensive educational initiatives about safety issues related to Seldane/Seldane-D use; and incorporates messages about proper use in all advertising and promotional materials.

The Medical Community can further our understanding of adverse events by reporting all cases to Hoechst Marion Roussel at 1-800-633-1610, or to the FDA MEDWATCH program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by modem at 1-800-FDA-7737 or by mail at:

Please see prescribing information on the following pages.

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