PUBBLICATO IL RAPPORTO MENSILE DEL PHARMACOVIGILANCE WORKING PARTY



EMEA, PHARMACOVIGILANCE WORKING PARTY (PHVWP) MONTHLY REPORT
Fonte: EMEA. Marzo 2010



E' disponibile il rapporto mensile del Pharmacovigilance Working Party pubblicato sul sito web dell'EMEA.
Tale rapporto riassume gli argomenti discussi nella riunione plenaria del PhVWP del 15-17 marzo 2010.

Sono riportate le seguenti tematiche:

DISCUSSIONS ON SAFETY CONCERNS
• Antidepressants – Risk of bone fractures
• Isotretinoin for oral use – Risk of erythema multiforme
• Lamotrigine – No evidence of increased risk of fatal liver failure
• Omeprazole and esomeprazole – Risk of reduced plasma levels of clopidogrel due to interaction
• PERFALGAN (paracetamol) 10 mg/ml solution for infusion – Risk of dosing errors in infants resulting in overdose with serious outcome
• Serotonergic antidepressants – Risk of persistent pulmonary hypertension of the newborn
• YASMIN/YIRA (ethinylestradiol 30µg + drospirenone) – Risk of venous thromboembolism
GUIDELINES AND GENERAL MATTERS
• CHMP Guideline on Duplicate Detection and Management of Individual Cases and Individual Case Safety Reports