Zafirlukast (Accolate®, AstraZeneca), a leukotriene receptor antagonist, was registered in Singapore in 1998 and is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.

The package insert of Accolate® has recently been updated to include important safety information relating to liver dysfunction following information obtained from worldwide postmarketing surveillance. Rare cases of symptomatic hepatitis (with or without hyperbilirubinaemia) without other attributable cause; and hyperbilirubinaemia without other elevated liver function tests have been reported, mostly in females who have received the recommended dose of Accolate® (40 mg/day). In most of the cases, the patient's symptoms abated and the liver enzymes returned to normal after stopping Accolate®. In rare cases, patients have progressed to hepatic failure.

The following information has been included under the sections on Contraindications and Warnings and Precautions of the package insert:

• Accolate® is contraindicated in patients with hepatic impairment of cirrhosis; it has not been studied in patients with hepatitis or in long-term studies of patients with cirrhosis. If clinical symptoms or signs suggestive of liver dysfunction occur (e.g. anorexia, nausea, vomiting, right upper quadrant pain, fatigue, lethargy, flu-like symptoms, enlarged liver, pruritus, and jaundice), the drug should be discontinued immediately rather than waiting for the confirmatory test results.
  
  
• Patients in whom Accolate® is withdrawn because of hepatotoxicity should not be re-exposed to Accolate®.