Monday, April 19, 2004

From Health Canada:
Important Safety Information Regarding Reports of Serious Hepatic Events in Patients Receiving ACCOLATE® (zafirlukast)
Dear Health Care Professional,

AstraZeneca Canada Inc. in consultation with Health Canada would like to update you on important safety information from post marketing experience with Accolate® (zafirlukast). From 1997 to December 31, 2003, one (1) case of hepatitis, 4 cases of hepatobiliary disorders or possible hepatitis, 1 case of hydrocholecystis and 4 cases of elevated liver enzymes have been reported in Canadian patients receiving Accolate®.

PUBLIC ADVISORY Health Canada Endorsed Important Safety Information on ACCOLATE® (zafirlukast)
AstraZeneca Canada Inc. following discussions with Health Canada would like to update you on important safety information regarding Accolate®, a non-steroidal tablet for chronic treatment of asthma in adults and children 12 years of age and older, available only by prescription.

Analysis of safety databases has shown that some patients taking Accolate® have experienced liver problems, some of which were serious (e.g. hepatitis). Very rarely severe liver injury, including liver failure (which may result in a fatal outcome), has been observed.

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