Overview
- Digemid ordered all paracetamol-containing products to update technical sheets and patient inserts, revising contraindications, warnings, interactions, and adverse reactions.
- The move follows an EMA alert linking prolonged therapeutic-dose use or use with flucloxacillin to high–anion–gap metabolic acidosis.
- Cases cited occurred mainly in patients with severe renal failure, sepsis, malnutrition, or chronic alcoholism, which are flagged as higher-risk conditions.
- Clinicians are instructed to suspend paracetamol and closely monitor patients if rapid deep breathing, severe respiratory difficulty, somnolence, nausea, or vomiting emerge.
- Peru’s pharmacovigilance system recorded 1,838 reports with 2,618 suspected adverse reactions from 2010 to May 2025, including one confirmed metabolic acidosis case and four compatible reports, and authorities urge reporting through the national system.