With increased use over the past three years, additional events have been reported for zafirlukast (Accolate®), a leukotriene receptor antagonist indicated for the prophylaxis and chronic treatment of asthma in adults and children 7 years of age and older. As a result, the precautions and adverse reactions sections of the package insert have been updated.
Based on reports of liver dysfunction, more specific recommendations are made for patient management, as follows. Hepatic events have occurred predominantly in females.
• If liver dysfunction is suspected based upon clinical signs, zafirlukast should be discontinued.
• If liver function tests are consistent with hepatic dysfunction, zafirlukast therapy should not be resumed and patients should not be re-exposed if no other attributable cause is identified.
In addition to the above changes, the adverse reactions section now also includes the information that reports have been received of patients experiencing arthralgia and myalgia in association with zafirlukast therapy.
Reference: Letter from AstraZeneca, USA, dated September 2000. http://www.fda.gov/medwatch