This Direct Healthcare Professional Communication would like to inform about the risk of teratogenicity, severe infections (sepsis, septic shock, and viral reactivation of hepatitis B), acute myeloid leukaemia and myelodysplastic syndromes, other second primary malignancies and Off-label use associated with Thalidomide Accord use.

Thalidomide Accord must be prescribed and dispensed according to the Pregnancy Prevention Programme (PPP) and by a controlled distribution system.