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Danish Pharmacovigilance Update, 25 April 2013

29 May 2013

In this issue of Danish Pharmacovigilance Update:

  • Cerebral haemorrhage in association with the use of methylphenidate (Ritalin® etc.) (front page)
  • Methylphenidate (Ritalin® etc.) – adverse reactions and the number of children and adults undergoing treatment during the period 2003-2012 (p 2)
  • Possible development of narcolepsy in association with vaccination with Pandemrix® (p 3)
  • Swedish registry study shows an increased risk of narcolepsy following vaccination with Pandemrix® in children and young adults (p 4)
  • Be aware of contraindications to dabigatran (Pradaxa®) (p 5)
  • New Danish study shows that Pradaxa® is equally effective as Marevan® (p 5)
  • Two cases of severe cutaneous reactions (SCAR) associated with telaprevir (Incivo®) combination treatment (p 6)
  • Rituximab (MabThera®) and severe skin reactions (p 7)
  • Risk of other haematological primary malignancies in patients undergoing treatment with thalidomide (Thalidomide Celgene®) (p 8)
  • New Danish study on valproate and the safety during pregnancy (p 8)
  • Report of a fatal case due to severe hypocalcaemia in a paediatric clinical trial involving treatment with cinacalcet (Mimpara®) (p 9)
  • The Danish Health and Medicines Authority's annual pharmacovigilance report 2012 (p 10)
  • The European Pharmacovigilance Risk Assessment Committee (PRAC) recommends restriction in the use of strontium ranelate (Protelos®) (p 10)