Danish Pharmacovigilance Update 31 October 2013

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