Monthly reports from the CHMP Pharmacovigilance Working Party (CHMP PhVWP) of the European Medicine Agency
07 April 2010
The Pharmacovigilance Working Party (PhVWP) is an expert working group which meets every month (except for August) at the European Medicines Agency in London, holding discussions on the safety surveillance of medicines (pharmacovigilance) in the European Union (EU). The Irish Medicines Board participates in all meetings of this Working Party.
The monthly reports of these meetings are published on the website of the European Medicines Agency.
The CHMP PhVMP held its March 2010 plenary meeting on 15-17 March 2010. A summary of the discussions regarding non-centrally authorised medicinal products is provided at the link below:
Information is included on the following products and safety concerns:
- antidepressants and risk of bone fractures,
- isotretinoin for oral use and risk of erythema multiforme,
- lamotrigine and evaluation of the risk of liver failure,
- omeprazole and esomeprazole and risk of reduced plasma levels of clopidogrel with concomitant use due to interaction potential,
- perfalgan (paracetamol) 10mg/ml solution for infusion and risk of dosing errors in infants resulting in overdose,
- serotenergic antidepressants and risk of persistent pulmonary hypertension of the newborn,
- Yasmin (ethinylestradiol 30µg + drospirenone) and risk of venous thromboembolism.