Class 4 drug alert, for information, Accord healthcare ltd, Atrolak XL prolonged release tablets, all strengths, (quetiapine fumarate)

The Patient Information Leaflet for specific batches are missing the detail that Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a potential side effect. HCPs are to ensure patients are aware of this when dispensing these batches.


Medicines and Healthcare products Regulatory Agency