Overview
- Digemid ordered updates to the technical data sheets and package inserts for all medicines containing paracetamol across Peru.
- The revised product information expands the sections on contraindications, warnings and precautions, drug interactions, and adverse reactions.
- Clinicians are advised to stop paracetamol immediately and monitor closely if signs of metabolic acidosis emerge, particularly with prolonged use or when prescribed with flucloxacillin.
- Patients at higher risk include those with severe renal failure, sepsis, malnutrition, or chronic alcoholism, and warning symptoms include rapid deep breathing, severe breathing difficulty, drowsiness, nausea, and vomiting.
- National pharmacovigilance data recorded 1,838 reports with 2,618 suspected adverse reactions from 2010 to May 2, 2025, including one confirmed acidosis case and four compatible reports, and authorities urge reporting to the Peruvian pharmacovigilance system.