Danish Pharmacovigilance Update, May 2011

01 June 2011

In this issue of Danish Pharmacovigilance Update:

  • Risk of renal failure and proteinuria to be added to the summary of product characteristics of Afinitor® (everolimus), which is used for treatment of advanced renal cell carcinoma
  • New warnings for Vectibix® (panitumumab) for treatment of metastatic colorectal carcinoma
  • New warning for Tasigna® (nilotinib) for treatment of chronic myeloid leukaemia
  • Tysabri® for treatment of multiple sclerosis and risk of progressive multifocal leukoencephalopathy (PML)
  • Bricanyl® turbohaler, 200 dose inhaler to be replaced by the 100 dose inhaler due to risk of delivery of excess dose
  • Octagam® to be marketed again
  • Status on adverse reaction reports regarding contraceptive pills
  • New study on the risk of venous thromboembolism from the use of Yasmin®
  • The Danish Medicines Agency’s annual pharmacovigilance report 2010