Danish Pharmacovigilance Update, 29 August 2013

17 October 2013, Updated 23 October 2013

In this issue of Danish Pharmacovigilance Update:

News from the EU

  • Cases of acquired haemophilia following treatment with clopidogrel (Plavix® etc.)
  • Change in indication and contraindication for panitumumab (Vectibix®)
  • Review of medicines containing zolpidem
  • European Medicines Agency recommends suspension of medicines containing ketoconazole for oral use
  • New recommendations for the use of painkillers containing diclofenac
  • Until further notice, plasma substitutes containing hydroxyethyl starch (HES) for volume replacement in case of blood or plasma loss should be avoided in critically ill patients – including patients with sepsis
  • Restrictions on the use of codeine for pain relief in children
  • Risk of developing peripheral neuropathy during use of the fluoroquinolones class of antibiotics

 News from the Danish Health and Medicines Authority

  • Report of urinary retention in association with the use of atomoxetine
  • The Danish Health and Medicines Authority's report on NSAIDs – a study of the number of users, reported suspected adverse reactions and inadvertent incidents

 Short news

  • Strong interest in Drug Analysis Prints with data from Danish adverse reaction reports
  • The Danish Health and Medicines Authority: Information about cervical cancer and HPV vaccination






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