A Missing Safety Warning in a PIL Became a Bigger GPvP Lesson

MHRA’s December 2025 Class 4 Medicines Defect Notification for certain amitriptyline tablets says the patient information leaflet contained out-of-date safety information, including missing warnings on serotonin syndrome and dry eye. The notice also states that the errors were identified following an MHRA Good Pharmacovigilance Practice inspection and further investigation by the marketing authorisation holder.

That makes this more than a leaflet correction. It shows how GPvP weaknesses can surface in patient-facing safety communication, not only in database or process findings. That conclusion is an inference from MHRA’s explicit link between the leaflet defect and the GPvP inspection.

For compliance teams, it is a useful reminder that pharmacovigilance quality has to reach all the way to the materials patients actually read.