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Title: Hoechst Marion Roussel Committed to Education Regarding Seldane Usage
URL: http://www.pslgroup.com/dg/800A.htm
Doctor's Guide
April 30, 1996


KANSAS CITY, Mo., April 30, 1996 -- Hoechst Marion Roussel, the pharmaceutical division of Hoechst AG, issued the following statement today in response to a study to be published in the May 1 issue of the Journal of the American Medical Association (JAMA) on the concomitant use of Seldane(R) (terfenadine) and contraindicated drugs:

Hoechst Marion Roussel is surprised by the continuing media attention to this issue. This issue is not new.

The fact is, Hoechst Marion Roussel is encouraged that our ongoing efforts to educate patients and health care professionals about this issue have resulted in a dramatic decrease (84 percent, as noted in the JAMA article) in the rates of same-day dispensing and overlapping use of Seldane and contraindicated prescription medications.

Hoechst Marion Roussel continues to be concerned that no patient be put at risk, and maintains its 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. 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 products since 1992. In addition, since 1992, the company has continued to support extensive educational initiatives about safety issues related to terfenadine use and incorporates messages about proper use in all advertising and promotional materials.

Hoechst Marion Roussel, a world leader in pharmaceutical-based health care, is dedicated to extending and enhancing human life through the discovery, development, manufacture and sale of pharmaceutical products. Hoechst Marion Roussel, with global headquarters in Frankfurt, Germany, is a member of the Hoechst Group. Hoechst Marion Roussel North America is headquartered in Kansas City, Mo.

WARNING: YOU MUST NOT TAKE SELDANE(R) (terfenadine) if you are also taking the prescription antifungal medicines itraconazole (Sporanox(R)) or ketoconazole (Nizoral(R)) or the prescription antibiotics erythromycin, clarithromycin (Biaxin(R)), or troleandomycin (TAO(R)), or if you have liver disease. DO NOT TAKE MORE THAN the amount prescribed by your doctor. Seldane has been associated with rare occurrences of abnormal heartbeats, heart attack, and death, under these conditions. For complete prescribing information, please call 800-552-3656.

Due to similarities in the drugs, it is also recommended that the antifungal drugs fluconazole, metronidazole, and miconazole and the antibiotic azithromycin not be used with Seldane.

Tell your doctor before taking Seldane if you have any liver or heart problems. Also, while using Seldane, tell your doctor if you ever feel faint, become dizzy, or have any irregular heartbeats.

Do not use Seldane with any other prescription or nonprescription medicines without first talking to your doctor. If you become pregnant or are nursing a baby, talk to your doctor about whether you should take Seldane. Your doctor will decide whether you should take Seldane based on the benefits and the risks.

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