EMA's PRAC recommends new restrictions on domperidone & diacerein
This article was originally published in Scrip
Executive Summary
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that products containing domperidone should remain on the market but with additional restrictions to reduce the risk of serious cardiac side-effects. The committee has also advised restrictions on diacerein-containing drugs in order to manage the risks of severe diarrhea and liver disorders, reversing its earlier recommendation to suspend the drug.