USA. Leflunomide (Arava) labelling in the US now includes more explicit liver function monitoring directions. The label now states that at the minimum, ALT must be performed at baseline and monitored initially at monthly intervals during the first six months and then, if stable, every six to eight weeks thereafter. The label previously recommended monthly monitoring until stable without mention of the 6-month timeframe or frequency of monitoring once stable. In addition, a bolded statement on severe liver injury has been added to the Warnings section and the manufacturer (Aventis) is to issue a ‘Dear Healthcare Professional’ letter regarding the labelling changes.
FDC Reports - Pink Sheet - Prescription Pharmaceuticals and Biotechnology 65: 7, 23 Jun 2003.