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Asthma Drug Maker Warns Doctors To Monitor Patients Closely 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 E-mail this page to a friend or colleague! To print, use this version