Danish Pharmacovigilance Update, 24 May 2012

31 July 2012

In this issue of Danish Pharmacovigilance Update:

  • Drug Analysis Prints involving data from more than 14,000 Danish adverse reaction reports available at the Danish Health and Medicines Authority’s website (front page)
  • Isotretinoin (Roaccutan® etc.) for the treatment of severe acne,and adverse reaction reports related to psychiatric symptoms (pp 2-4)
  • Risk of developing acute and chronic pulmonary changes in treatment with Nitrofurantoin® (p 5)
  • Risk of developing atrioventricular block under treatment with Gilenya® (p 5)
  • Tacrolimus (Protopic®) and the risk of malign conditions (pp 6-7)
  • Risk of blood clots associated with hormonal contraceptives (p 8)
  • Focus on consumption development,adverse reactions reported, age and dose recommendations in relation to Pradaxa® (p 8)