Overview
- All medicines containing paracetamol in Peru will carry revised technical data sheets and patient leaflets.
- Changes affect the sections on contraindications, warnings and precautions, drug interactions, and adverse reactions.
- Reported cases occurred mainly in patients with severe renal failure, sepsis, malnutrition, or chronic alcoholism, consistent with pyroglutamic acidosis.
- Health professionals are urged to avoid prolonged use in severely ill patients, suspend paracetamol at the first signs of metabolic acidosis, and monitor closely.
- Warning symptoms include rapid deep breathing, severe breathing difficulty, somnolence, nausea, and vomiting; Peru’s database logged 1,838 reports since 2010, including one confirmed metabolic acidosis case and four compatible reports.