Voluntary recall of Avandia (4mg rosiglitazone tablets) due to a tablet dissolution quality issue

GSK would like to inform healthcare professionals of the voluntary recall of Avandia 4mg (rosiglitazone) tablets due to a tablet dissolution quality issue. Based on the results, the dissolution testing of the affected Avandia tablets may be incomplete or delayed. Considering the changed dissolution profile, long term and continuous nature of the treatment and pharmacodynamic effects of the drug, the potential clinical impact for patients relates to the efficacy of rosiglitazone. As a precautionary measure, GSK will be undertaking the recall of the affected batches. However, replacement supplies of Avandia are not available and therefore patients will need to switch to alternative therapies. Healthcare professionals are advised not to prescribe further courses of Avandia and to refer to the MOH clinical practice guidelines (2014) on the management of diabetes mellitus to determine the appropriate replacement therapies for their respective patients. Healthcare professionals can do the check on glucose levels as per clinical discretion when shifting patients to alternative oral glucose lowering agents to achieve intended blood levels for their patients. Please refer to the Dear Healthcare Professional Letter (DHCPL) for more details.