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Gambia children deaths are associated with syrup made by Maiden Pharmaceuticals, says US CDC

 

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Gambia children deaths are associated with syrup made by Maiden Pharmaceuticals

Centers for Disease Control and Prevention (CDC) US researchers said that the Gambia children deaths are associated with syrup made by Maiden Pharmaceuticals. Their investigation strongly suggests that medications contaminated with diethylene glycol (DEG) or ethylene glycol (EG) imported into The Gambia led to this acute kidney injury (AKI) cluster among children.

On July 26, 2022, a pediatric nephrologist alerted The Gambia’s Ministry of Health (MoH) to a cluster of cases of acute kidney injury (AKI) among young children at the country’s sole teaching hospital, and on August 23, 2022, MoH requested assistance from CDC.
CDC epidemiologists arrived in The Gambia, a West African country, on September 16 to assist MoH in characterizing the illness, describing the epidemiology, and identifying potential causal factors and their sources. Investigators reviewed medical records and interviewed caregivers to characterize patients’ symptoms and identify exposures. The preliminary investigation suggested that various contaminated syrup-based children’s medications contributed to the AKI outbreak. During the investigation, MoH recalled implicated medications from a single international manufacturer. Continued efforts to strengthen pharmaceutical quality control and event-based public health surveillance are needed to help prevent future medication-related outbreaks.

Preliminary reports from the treating physicians at the teaching hospital indicated that caregivers had administered paracetamol and promethazine to their children before their development of AKI.

Based on this information, MoH advised the public to suspend use of all paracetamol and promethazine syrups on September 7, 2022, and September 16, 2022, respectively (Figure). The laboratory analysis of 23 medication samples conducted by MoH and WHO confirmed that four products from Maiden Pharmaceuticals Limited (Haryana, India) contained diethylene glycol (DEG) and ethylene glycol (EG). Based on records from The Gambia’s Medicines Control Agency, all medications that tested positive for DEG and EG were imported into The Gambia on June 21, 2022, shortly before the occurrence of the first AKI cases.


On October 4, 2022, MoH suspended the importation of all medications from this manufacturer and requested that health care providers stop prescribing, dispensing, and using medications produced by this manufacturer because of their possible contamination. On October 5, 2022, WHO issued a worldwide medical product alert for four syrup-based medications from Maiden Pharmaceuticals.

DEG mass poisonings continue to occur worldwide, especially in low-resource settings. Strengthened international pharmaceutical regulatory structures and event-based surveillance systems can help prevent DEG-associated large-scale poisoning events.