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