MARION MERRELL DOW MODIFIES LABEL FOR TERFENADINE FAMILY
MARION MERRELL DOW MODIFIES LABEL FOR TERFENADINE FAMILY KANSAS CITY, Mo., July 7 /PRNewswire/ -- Marion Merrell Dow Inc.
(NYSE: MKC) today announced plans to modify the current labeling for its terfenadine family of prescription antiallergy products and a program to communicate these changes to health care professionals and the public.
The company said its objective in making these changes was to broaden initiatives, which began in 1990, to alert physicians that patients with certain previously identified risk factors should not use terfenadine (known as Seldane(R) and Seldane-D(R) in the United States). These include: -- Patients using ketoconazole, a prescription antifungal -- Patients using erythromycin, a prescription antibiotic -- Patients with serious liver disease "While Seldane has had widespread use in over 200 million patients since its introduction in 1981, we are concerned that any patient ever be at risk, no matter how rare the incidence," said Fred W. Lyons, Jr., president and chief executive officer. "For this reason, extensive studies will continue to clarify the underlying risk factors. "The safety of the patients who use our products is our primary consideration, and we are committed to ensuring that the medical community as well as the public have a clear understanding of the appropriate use of our products," Lyons continued. "To demonstrate this continuing commitment to patient safety, we are implementing a detailed plan to communicate the labeling changes to health care professionals, terfenadine users and other allergy sufferers as quickly as possible." Lyons noted that patients with questions about the terfenadine label changes should contact their doctors. He also explained that the company had established a toll free telephone number, 800-395-6825, which health care professionals may call for additional information on the labeling changes. The specific modifications to be made to the terfenadine label include: -- Contraindicating terfenadine for use by patients taking ketoconazole or erythromycin or in patients with serious liver disease. Since 1990, the label for terfenadine has included a precaution discussing the potential for the rare occurrence of cardiovascular events in these patient groups. -- A notation that the recommended dosage of terfenadine, 60 mg twice daily, should not be exceeded. -- Placing the contraindications and the notation on dosing in a box to increase their visibility. The labeling modifications to be implemented in the United States also will be discussed with regulatory authorities in all countries where terfenadine is sold. The primary elements of the communications plan in the United States include mailgrams and letters to physicians, nurses, pharmacists and patients as well as the inclusion of the contraindications in direct-to-consumer advertising and professional education activities. The letters and mailgrams will reference the toll-free telephone number. In addition, the company will develop a pamphlet discussing the contraindications for distribution to patients. "In addition to these steps, we will exchange our extensive new scientific information related to the safety of terfenadine with the FDA and other regulatory agencies around the world," Lyons continued. The company said the new scientific information will be reviewed by an expert scientific panel in the United States at a later date. Pending the scientific review, Lyons said the company has decided to re-evaluate the submission of a new drug application for an over- the-counter version of Seldane(R) in the United States. That submission had been expected in the near future. Marion Merrell Dow, headquartered in Kansas City, is a global pharmaceutical company whose business activities focus on the discovery, development, manufacturing and marketing of prescription and over-the-counter pharmaceutical products. The company markets its products, primarily in the United States and seven countries in North America, Europe and the Pacific Basin. -0- 7/7/92 /CONTACT: David M. Thompson or Richard M. Johnson both of Marion Merrell Dow, 816-966-4982/ (MKC) CO: Marion Merrell Dow Inc. ST: Missouri IN: MTC SU:
BB -- DV003 -- 6956 07/07/92 11:14 EDT
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|Date:||Jul 7, 1992|
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