Danish Pharmacovigilance Update, 15 March 2012

19 June 2012

In this issue of Danish Pharmacovigilance Update:

  • A new registry study has investigated the frequency of malformations in newborns after treating the mother with antidepressants (SSRI) during the pregnancy (front page)
  • The first results from a new study on Pradaxa® (dabigatran etexilate) (pp 2-3)
  • Interaction between Victrelis (boceprevir) and ritonavir-boosted HIV protease inhibitors (p 4)
  • Review of Vivaglobin® completed (p 5)
  • New contraindications and warnings for blood pressure medicine containing aliskiren (Rasilez® and Rasilez® HCT) (p 5)
  • Statins and myopathy/rhabdomyolysis (p 6)
  • The U.S. Food and Drug Administration updates the product information for statins in the USA (p 7)
  • The benefits from the use of medicine containing orlistat still outweigh the potential risks (p 7)
  • Adverse reactions when using gestagen-containing intrauterine contraceptives (Mirena®) (p 8)
  • Childhood vaccinations and adverse reactions in the fourth quarter of 2011 (pp 9-10)