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Pemoline-associated fulminant liver failure: testing the evidence for causation
M Berkovitch1, E Pope, J Phillips
1Division of Clinical Pharmacology/Toxicology, Hospital for Sick Children, Toronto, Ontario, Canada.
Clinical Pharmacology and Therapeutics
|June 1, 1995
Summary
Pemoline, a stimulant for attention deficit-hyperactivity disorder, is linked to a significantly increased risk of fatal liver failure in children. This finding highlights the need for further research into pemoline
Area of Science:
- Pediatric Pharmacology
- Hepatology
- Neurodevelopmental Disorders
Background:
- Pemoline is a central nervous system stimulant prescribed for attention deficit-hyperactivity disorder (ADHD) in children.
- Hepatotoxicity is a known risk associated with pemoline, with limited published cases of fatal liver failure.
Observation:
- A case report details a 14-year-old boy experiencing fulminant liver failure while on concomitant pemoline and methylphenidate.
- Liver biopsy results were indicative of drug toxicity, and other causes of liver failure were excluded.
- Liver transplantation was unsuccessful in this patient.
Findings:
- Analysis of three reported cases suggests pemoline use in children with ADHD is associated with a 45.3-fold increased relative risk of developing fulminant liver failure (95% CI, 4.1–510).
- The calculated risk is statistically significant (p < 0.001), strongly suggesting a causal relationship between pemoline and fatal hepatotoxicity.
Implications:
- Given the widespread use of pemoline, further studies are crucial to accurately quantify the risk of severe hepatotoxicity in pediatric ADHD patients.
- These findings underscore the importance of vigilant monitoring for liver injury in children treated with pemoline.