Three country comparison of selected safety information in the prescribing information for rosiglitazone [avandia]

A meta-analysis of 42 clinical trials published in 2007 found an increased risk of cardiac ischemia with the use of rosiglitazone [Avandia]. A communication from rosiglitazone's manufacturer indicated that safety revisions would be made the drug's prescribing information in Saudi Arabia. This prompted a comparison between selected safety information in the prescribing information for the drug available in the U.K., U.S. and Saudi Arabia. Three pharmacists conducted a comparison of selected safety information from the most recent prescribing information for rosiglitazone available in the U.K., U.S. and Saudi Arabia including the Arabic translation of the prescribing information available in The Kingdom. Differences in opinion or interpretation of the information contained in the prescribing information from the three countries were resolved by consensus. The prescribing information in Saudi Arabia for the drug was last revised in 2007. This information was amended in the U.K. and U.S. in March 2008 and July 2008 respectively. Compared to the U.K. and U.S. prescribing information the Saudi Arabian prescribing information there were differences in contraindications cardiac ischemia information, facture risk, and concomitant use with insulin. Saudi Arabian prescribers and patients should have access to the same safety information as their counterparts in the U.K. and U.S. In this three country comparison differences were found in the number and strength of selected categories of safety information for rosiglitazone. Information is provided on how to access the most current revisions of the prescribing information for drugs approved in Saudi Arabia that are also available in the U.K. or U.S. on the Internet at no charge