Peru Issues Health Alert Over Paracetamol Risks, Cites Potential for Rare Acidosis
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The Peruvian health authority, Digemid, has issued a nationwide health alert regarding the use of paracetamol, a widely used pain reliever and fever reducer, after identifying a rare but potentially serious risk of metabolic acidosis in certain patients. The agency is mandating updates to drug labeling to reflect the newly identified risks, based on evaluations from the European Medicines Agency (EMA) and national pharmacovigilance data.
The warning centers around an increased risk of developing high anion gap metabolic acidosis – a dangerous disruption of the body’s acid-base balance – in individuals who take paracetamol for extended periods or in combination with the antibiotic flucloxacillin. Digemid emphasizes that this risk is heightened for those with pre-existing serious health conditions.
Who is Most at Risk?
According to the health alert, individuals with severe kidney failure, sepsis, malnutrition, or chronic alcoholism should exercise extreme caution when using paracetamol. These patients are strongly advised to avoid self-medication and consult a physician before taking the analgesic. “The consumption of the analgesic can promote an alteration of the acid-base balance of the blood,” a senior official stated, “a condition that can become serious if it is not detected in time.” Digemid recommends that these vulnerable populations only use paracetamol under strict medical supervision and for the shortest duration necessary.
Recognizing the Symptoms of Metabolic Acidosis
Digemid is urging both healthcare professionals and the public to be vigilant for symptoms of metabolic acidosis, which can include:
- Severe respiratory distress with rapid and deep breathing
- Sleepiness or lethargy
- Nausea and vomiting
- Intense fatigue
- Confusion or general discomfort
If any of these signs appear while taking paracetamol, Digemid strongly advises immediately stopping the medication and seeking prompt medical attention.
Reporting Adverse Reactions
The agency also reiterated the importance of reporting any suspected adverse reactions associated with medication use to the Peruvian Pharmacovigilance and Technovigilance System. This reporting is crucial for strengthening health surveillance and preventing future risks to the population.
To further mitigate these risks and protect public health, Digemid has issued specific recommendations to healthcare professionals. Upon detecting symptoms of metabolic acidosis in patients receiving prolonged paracetamol treatment or in combination with flucloxacillin, the drug should be immediately discontinued, and the patient should be closely monitored.
Pharmacovigilance Data Reveals Trends
Analysis of data from the National Center for Pharmacovigilance and Technovigilance (CENAFyT) reveals a significant number of reported adverse reactions associated with paracetamol use. Between 2010 and May 2, 2025, CENAFyT received 1,838 reports encompassing 2,618 suspicions of adverse reactions. The 18-44 age group accounted for the highest proportion of these reports, with 838 cases representing 45.6% of the total.
One identified case involved metabolic acidosis alongside other adverse reactions, including abdominal pain, drowsiness, a confusional state, elevated liver enzymes (hypertransaminasemia), increased lactic acid levels (hyperlactacidemia), overdose, abnormal liver function, and an anaphylactoid reaction. Additionally, four cases were reported exhibiting symptoms consistent with metabolic acidosis, such as shortness of breath, vomiting, drowsiness, nausea, and fatigue.
Digemid’s proactive response underscores the importance of ongoing pharmacovigilance and responsible medication use, even with commonly available drugs like paracetamol. The agency’s alert serves as a critical reminder for both patients and healthcare providers to remain informed and prioritize patient safety.
