To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Asthma Drug Maker Warns Doctors To Monitor Patients Closely URL: http://www.pslgroup.com/dg/31F26.htm Doctor's Guide July 23, 1997
WASHINGTON, MD -- July 23, 1997 -- Zeneca Pharmaceuticals, maker of Accolate (zafirlukast), is notifying health care providers of a possible association with a rare and sometimes fatal condition known as Churg-Strauss Syndrome. The warning came as a result of reports of six asthma patients who developed Churg-Strauss Syndrome while taking zafirlukast, a popular asthma treatment, according to the U.S. Foor and Drug Administration (FDA). These data, however, do not definitively demonstrate that the drug caused the condition. Churg-Strauss Syndrome occurs in adult asthma patients and may appear as generalized, flu-like symptoms such as fever, muscle aches and pains, and weight loss. Patients also experience inflammation of blood vessels, primarily in the lungs. If left untreated, Churg-Strauss Syndrome can result in major organ damage and even death. The FDA stresses that despite the severity of Churg-Strauss Syndrome, and in light of the rarity of its occurrence, it does not recommend that patients discontinue any asthma medication without consulting their health care provider. In fact, Churg-Strauss Syndrome is often treated with oral steroids, the same treatment that is used for patients with severe asthma. Based on present information, the agency continues to believe the benefits of this drug outweigh any of its known or potential risks. Thus far, all reported cases have occurred in patients whose steroidal asthma medications were being gradually lowered or discontinued while receiving zafirlukast. Zeneca Pharma has ensured that new labeling for zafirlukast will warn health care providers of this possible problem and urge them to monitor their patients carefully when corticosteroids are being tapered or discontinued. Approved in September 1996, zafirlukast is the first in a new class of drugs designed as a nonsteroidal, asthma prophylaxis and treatment for patients aged 12 or older. More information on: Zeneca Pharmaceuticals, Accolate --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.