Danish Pharmacovigilance Update, April 2011

13 May 2011

In this issue of Danish Pharmacovigilance Update:

  • Possible risk of second primary malignancies in patients treated with Revlimid® (lenalidomide)
  • New contraindication for Telzir® (fosamprenavir) for HIV treatment
  • New dosing recommendation for Votrient® (pazopanib) for treatment of advanced renal cell carcinoma
  • New contraindication for Xyrem® (sodium oxybate) for treatment of narcolepsy
  • Information about the occurrence of serious hypersensitivity reactions has been added to the summary of product characteristics of Efient® (prasugrel) for the prevention of atherothrombotic events
  • Analgesic (NSAID) and risk of gastric ulcers in arthritic sufferers
  • Swedish study raises suspicion about link between Pandemrix® (the H1N1 vaccine) and the sleep disorder narcolepsy in children and adolescents.
  • Reports of blood clots from the use of Vivaglobin®
  • Childhood vaccination and adverse reactions in 2010
  • New improved e-forms for reporting suspected adverse reactions
  • The Danish Medicines Agency’s annual pharmacovigilance report 2010

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