Danish Pharmacovigilance Update, 21 March 2013

25 April 2013

In this issue of Danish Pharmacovigilance Update:

  • Depressive and suicidal thoughts following discontinuation of varenicline (Champix®) (front page)
  • Risk of femoral fracture during treatment with Prolia® (denosumab) (p 2)
  • The European Medicines Agency (EMA) is reviewing benefits and risks of the nicotinic acid analogue acipimox (Olbetam®) for the treatment of elevated cholesterol levels (p 3)
  • Nulojix® (belatacept) and increased incidence of acute graft rejection in certain specific cases (p 4)
  • Risks associated with off-label use of NeuroBloc® (botulinum toxin type B) (p 5)
  • Childhood vaccinations and suspected adverse reactions in the third and fourth quarter of 2012 (pp 6-10)

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