As Medical Affairs professionals, we know that quality is a central component of drug development and manufacturing and remains central throughout the entirety of the development and manufacturing processes. Unfortunately, quality controls in place at manufacturing plants sometimes lack rigidity and oversight, and incidents impacting patient safety may occur. This is the case for hundreds of children who passed away in Gambia and Indonesia. The deaths of nearly 100 children in Indonesia, weeks after a cough syrup in Gambia was linked to the deaths of nearly 70 children, prompted Indonesia to suspend sales of all syrup and liquid medications in the country.

According to Indonesia, some syrup medicines were found to contain ingredients linked to acute kidney injuries (AKI), resulting in the deaths of 99 young children so far this year. It is unclear if the medicines were imported or locally produced.

Further, Indonesian health officials said they had reported around 200 cases of AKI in children, most of whom were under the age of five. Earlier this month, the WHO issued a global alert over four cough syrups that were linked to the deaths of almost 70 children in Gambia. The WHO found the syrups used there – made by an Indian pharmaceutical company – contained “unacceptable amounts” of diethylene glycol and ethylene glycol. The syrups have been “potentially linked with acute kidney injuries”, said the organization.

Indonesia’s Health Minister on Thursday said the same chemical compounds were also found in some medicines used locally. “Some syrups that were used by AKI child patients under five were proven to contain ethylene glycol and diethylene glycol that were not supposed to be there, or in very little amount.”

Indonesian authorities said the cough syrups used in Gambia were not sold locally. One epidemiologist said the true death toll could be even higher than reported.

“When cases like these happen, what we know is the tip of the iceberg, which means there could be far more victims,” commented Dicky Budiman, an epidemiologist from Griffith University.1

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References

  1. Thiagarajan, K. (2022, October 14). WHO investigates cough syrups after deaths of 66 children in Gambia. The BMJ. https://www.bmj.com/content/379/bmj.o2472

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