Paracetamol in therapeutic dosages and acute liver injury: causality assessment in a prospective case series
2011

Paracetamol and Acute Liver Injury

Sample size: 32 publication 10 minutes Evidence: moderate

Author Information

Author(s): Sabaté Mònica, Ibáñez Luisa, Pérez Eulàlia, Vidal Xavier, Buti Maria, Xiol Xavier, Mas Antoni, Guarner Carlos, Forné Montserrat, Solà Ricard, Castellote José, Rigau Joaquim, Laporte Joan-Ramon

Primary Institution: Fundació Institut Català de Farmacologia, Universitat Autònoma de Barcelona

Hypothesis

What are the characteristics of patients with acute liver injury who have taken therapeutic doses of paracetamol?

Conclusion

Paracetamol in therapeutic dosages may be a factor in liver injury in non-alcoholic patients, although the incidence appears to be low.

Supporting Evidence

  • The estimated incidence of ALI related to paracetamol was 0.4 per million inhabitants older than 15 years per year.
  • In 7 out of 26 cases, the RUCAM score for paracetamol was higher than for other medications.
  • Six patients had a hepatocellular pattern of liver injury, which is typical for paracetamol overdose.

Takeaway

This study looked at people who got sick from taking normal amounts of paracetamol and found that it can sometimes hurt the liver, but it's rare.

Methodology

The study assessed 32 cases of acute liver injury in patients exposed to therapeutic doses of paracetamol, using the CIOMS/RUCAM scale for causality assessment.

Potential Biases

The study may have selection bias as it focused only on serious cases of acute liver injury.

Limitations

Causality assessment relied on algorithms that may underestimate the role of unknown hepatotoxic drugs and did not account for hypersensitivity symptoms.

Participant Demographics

The median age of participants was 35, with a range from 18 to 85 years, and included both males and females.

Statistical Information

P-Value

0.4 per million inhabitants per year

Confidence Interval

99%CI, 0.2-0.8; 95% CI 4.3-19.4

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1471-230X-11-80

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