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US Food and Drug Administration
Zafirlukast (Accolate) and Churg Strauss Syndrome
FDA Talk Paper (Jul) T97:34 1997
The text of this drug alert is available from the US Food and Drug administration this site. It is reproduced below:
FDA TALK PAPER Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T97-34 Ivy Fleischer Kupec: 301-443-3285 July 23, 1997 Broadcast Media: 301-827-3434 Consumer Hotline: 800-532-4440 HEALTH ADVISORY FOR NEW ASTHMA DRUG Zafirlukast (Accolate), a popular asthma treatment, has recently been associated with a rare and sometimes fatal condition known as Churg-Strauss Syndrome. The drug's manufacturer, Zeneca Pharmaceuticals, is now notifying health care providers of this possible drug side effect after FDA learned of six asthma patients who developed Churg-Strauss Syndrome while taking zafirlukast. 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. Despite the severity of Churg-Strauss Syndrome, in light of the rarity of its occurrence FDA 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. 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. ####A copy of the July 22, 1997, letter from Zeneca Pharmaceuticals to health-care professionals is available on this Web site.
