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Danish Pharmacovigilance Update, 21 February 2013

25 April 2013

In this issue of Danish Pharmacovigilance Update:

  • Cardiovascular monitoring when initiating and re-initiating treatment with fingolimod (Gilenya®) (front page)
  • Adverse Drug Reaction Manager assists the Capital Region of Denmark with adverse reaction reporting (p 2)
  • Liver function monitoring recommended due to the risk of liver diseases from the use of Revlimid® (lenalidomide) (p 3)
  • Reports of adverse reactions concerning psychological changes in patients treated with levodopa (p 3)
  • Doctors in Denmark continue to follow recommendations for contraceptive pills (p 4)
  • The European Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety of acne medicines containing cyproterone and oestrogen (Diane® Mite and others) (p 5)
  • Risk of cardiovascular adverse reactions in patients with essential thrombocythaemia (ET) in association with anagrelide hydrochloride (Xagrid®)m (p 6)
  • Direct safety information (DHPC*) for doctors and other healthcare professionals will be made available on the Danish Health and Medicines Authority's website (p 7)