Fatal renal failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic.

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.