Danish Pharmacovigilance Update, 25 April 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)