The General Directorate of Medicines, Supplies and Drugs (Digemid) recently issued a health alert for the use of paracetamolone of the most consumed analgesics and antipyretics in the country, after noticing a rare but serious risk associated with its prolonged use or combined with certain antibiotics.
As previously reported, the official warning prompted the updating of technical sheets and inserts of medicines containing paracetamol, incorporating new details on contraindications, warnings, interactions and adverse reactions. The measure was adopted after European regulatory authorities warned about cases of high anion gap metabolic acidosisa condition that can be life-threatening.
Digemid He pointed out that this complication has been identified mainly in patients with serious illnesses who received the drug for prolonged periods or together with flucloxacillin, which is why he urged the population to avoid self-medication and consult with a health professional if any unusual symptoms occur.
Beyond the regulatory update, pharmacovigilance records in Peru account for the widespread use of paracetamol and its eventual adverse effects. According to the National Center for Pharmacovigilance and Technovigilance (CENAFyT), Between 2010 and May 2, 2025, 1,838 notifications were received, in which 2,618 suspected adverse reactions related to medications containing paracetamol were reported.
The analysis of the reports shows that the age group of 18 to 44 years concentrated the largest number of notifications, with 838 caseswhich represents the 45.6% of the total. Although most of these reactions were not serious, the data support the need to strengthen surveillance of a widely used drug.
Within this set of notifications, Digemid identified a confirmed case of metabolic acidosiswhich occurred along with other adverse events such as abdominal pain, somnolence, confusional state, alterations in liver function, hyperlactacidemia and an anaphylactoid reaction. Furthermore, it was reported four additional cases with symptoms compatible with this condition, including respiratory distress, vomiting, nausea, drowsiness and fatigue.
Given these findings, the health authority reiterated that the Risk increases in patients with severe kidney failure, sepsis, malnutrition or chronic alcoholismespecially when paracetamol is used for a long time or in combination with flucloxacillin. In these cases, it is recommended to discontinue the medication when symptoms appear and perform an immediate medical evaluation.
Finally, Digemid recalled that all suspected adverse reactions must be communicated to the Peruvian Pharmacovigilance and Technovigilance Systemin order to strengthen the monitoring of drug safety and prevent new events that may affect the health of the population.
The symptoms of metabolic acidosis associated with the use of paracetamolAccording to the Digemid alert, they may include:
- Severe respiratory distresswith breathing fast and deep
- Sleepiness or extreme tiredness
- Nausea
- Vomiting
- intense fatigue
- In some cases, confusion or general discomfort
