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Fatal renal failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic
M Hanif1, M R Mobarak, A Ronan
1Department of Nephrology, Dhaka Shishu Hospital, Bangladesh.
Insights
Contaminated paracetamol elixirs containing diethylene glycol caused a severe outbreak of unexplained renal failure in children in Bangladesh. A ban on these products led to a significant decrease in new renal failure cases.
Area of Science:
- Pediatric Nephrology
- Toxicology
- Public Health Epidemiology
Background:
- A significant increase in unexplained renal failure among children was observed.
- The etiology of this pediatric renal failure outbreak remained unknown.
Purpose of the Study:
- To investigate the cause of a surge in unexplained pediatric renal failure.
- To identify risk factors and causative agents associated with the outbreak.
Main Methods:
- A case-control study was conducted involving children admitted to a hospital in Dhaka, Bangladesh.
- Cases included 339 children with unexplained renal failure; controls were 90 children with identified causes.
- Toxicological analysis of paracetamol samples and clinical data comparison were performed.
Main Results:
- Children with unexplained renal failure were more likely to have hepatomegaly, edema, hypertension, and higher serum creatinine.
- A significant proportion of unexplained renal failure cases were linked to paracetamol ingestion containing diethylene glycol.
- Following a ban on paracetamol elixir, new renal failure cases decreased by 54% and unexplained cases by 84%.
Conclusions:
- Diethylene glycol-contaminated paracetamol elixirs were identified as the cause of a major outbreak of fatal renal failure in Bangladesh.
- Public health interventions, such as product bans, can effectively mitigate outbreaks of toxicant-induced disease.
Objective:
To determine the cause of a large increase in the number of children with unexplained renal failure.
Design:
Case-control study.
Setting:
Children's hospital in Dhaka, Bangladesh.
Subjects:
Cases were all 339 children with initially unexplained renal failure; controls were 90 children with cause of renal failure identified; all were admitted to hospital during 35 months after January 1990.
Main Outcome Measures:
Differences between the case and control patients in clinical and histological features and outcome; toxicological examination of 69 bottles of paracetamol from patients and pharmacies.
Results:
Compared with children with an identified cause for their renal failure, children with initially unexplained renal failure were significantly (P < 0.05) more likely to have hepatomegaly (58% v 33%), oedema (37% v 20%), and hypertension (58% v 23%); to have a higher serum creatinine concentration (mean 519 mumol/l v 347 mumol/l) and lower serum bicarbonate concentration (10.1 mmol/l v 12.4 mmol/l); to have been given a drug for fever (91% v 31%); to have ingested a brand of paracetamol shown to contain diethylene glycol (20% v 0%); and to have died in hospital (70% v 33%). Diethylene glycol was identified in 19 bottles of paracetamol, from 7 of 28 brands tested. In the 12 months after a government ban on the sale of paracetamol elixir, new cases of renal failure decreased by 54%, and cases of unexplained renal failure decreased by 84%.
Conclusion:
Paracetamol elixirs with diethylene glycol as a diluent were responsible for a large outbreak of fatal renal failure in Bangladesh.