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Formal Removal From Category 2 and Addition to an Approved List A durable change would require: Review of safety data Advisory committee input Publication in the Federal Register Compliance with the Administrative Procedure Act This process is slow and procedural

Since no other cause for the metabolic acidosis could be found, the possibility of accumulation of 5-oxoproline by paracetamol and flucloxacillin was recognised and the treatment with paracetamol was stopped

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