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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


     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.