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Danish Pharmacovigilance Update 31 October 2013

05 March 2014

In this issue of Danish Pharmacovigilance Update:

News from the EU

  • The risk of blood clots from the use of contraceptive pills is low regardless of type
  • The EU has completed the review of plasma substitutes containing hydroxyethyl starch (HES)
  • Risk of intraoperative floppy iris syndrome (IFIS) related to treatment with risperidone or paliperidone in patients undergoing cataract surgery
  • Updated recommendations for the use of intravenous iron products
  • Knowledge of the use of valproate during pregnancy will be reviewed in the EU
  • Common labelling of medicines under additional monitoring in the EU

News from the Danish Health and Medicines Authority

  • Report of cardiac arrest in association with the use of flecainide (Tambocor®)
  • Granuloma formation following vaccination with aluminium adjuvant vaccines – a known, but rare adverse reaction
  • Always remember to include both the product name and batch number when submitting reports of suspected adverse reactions from vaccines and biological drugs