Weeks after a select committee of The Gambia National Assembly concluded that the deaths of 70 children due to acute kidney injury (AKI) were linked to consumption of four contaminated syrups made by India’s Maiden Pharmaceuticals, a report by the US Centers for Disease Control and Prevention released Friday said contaminated syrup imported to The Gambia led to the cluster of AKI and deaths in children.
“This investigation strongly suggests that medications contaminated with DEG (diethylene glycol) or EG (ethylene glycol) imported into The Gambia led to this AKI cluster among children,” the report stated. CDC scientists investigated the matter on a request from The Gambia’s Ministry of Health. The report is based on medical records of children and interviews with caregivers of some who died of AKI. In addition to the information gathered, the report said testing of the medicines previously through the WHO also supported the cause of cluster of AKI cases.
“Further support for a toxic etiology includes the wide geographic distribution of cases in the country (six of seven health regions), a common pharmaceutical manufacturer of medications reported to have been used by many patients, and a low rate of intrahousehold spread. This intoxication appears to have only affected children, likely because medications in syrup form are most commonly used for children in The Gambia,” the CDC report stated.
Last year, 80 children were confirmed to have suffered from AKI in The Gambia between June and November. Of them, 70 died.
The conclusion of the CDC report that the deaths were linked to the syrups is based on interviews with 26 caregivers, all of whom said that the children had consumed at least one syrup-based medication. Twelve children had, in fact, consumed four or more medications before being hospitalised.
Only 14 of the 26 caregivers were able to recall the names of the medications, with eight of them stating that a syrup by Maiden was used.
According to the report, published in CDC’s Morbidity and Mortality Weekly Report, the CDC got involved in September last year after a paediatric nephrologist from The Gambia’s only teaching hospital raised concern over an increase in AKI cases.
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After actively looking for cases across hospitals, 78 were detected by September. Of these, 66 or 85% died. 75% of the cases were in children below the age of 2 years and 80% were male.
Last October, the WHO raised a medical product alert for four syrups manufactured by Haryana-based Maiden pharmaceuticals, linking it to the AKI and deaths.
Later, a report in The Gambia National Assembly said, “The Select Committee is convinced that Maiden Pharmaceuticals Ltd is culpable and should be held accountable for exporting the contaminated medicines that were linked to the death of at least 70 children.”
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Maiden denied the allegations. Its manufacturing unit in Sonepat was shut down by the Central Drugs Standard Control Organisation.
India maintained that enough evidence was not provided by The Gambia or WHO to establish a causal link between the deaths and the Indian syrups. The control samples were found to be of standard quality by the Indian drug regulator
Gambia linked India syrup to kids’ deaths, now CDC confirms - The Indian Express
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