Pharmacy Daily | EMA meds guidance

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of domperidone-containing medicines and has recommended changes to their use including using these medicines only to relieve symptoms of nausea and vomiting, restricting the dose and adjusting doses carefully by weight where it is licensed in children. A review of zolpidem-containing medicines (Stilnox), used for the short-term treatment of insomnia has also resulted in recommended changes to the product information, aimed at further minimising the known risks of nextmorning impaired driving ability and mental alertness (including somnambulism). The EMA has also reviewed Diacerein (an interleukin-1 blocker) and recommended that it remain available with restrictions including being unavailable to patients over 65 years so as to limit risks of severe diarrhoea and liver effects.

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