US probe blames Maiden for kids' death in Gambia
Bhartesh Singh Thakur
Chandigarh, March 4
The Centres for Disease Control and Prevention (CDC), US, has said that syrups contaminated with diethylene glycol (DEG) or ethylene glycol (EG) imported into Gambia led to an outbreak of acute kidney injury (AKI) in the country in 2022. Haryana’s Maiden Pharmaceuticals has been implicated for sending contaminated syrups to the West African nation, which led to the death of at least 66 children.
In its Morbidity and Mortality report, dated March 3, the CDC stated, “The implicated syrup-based paediatric medications that were administered to patients were imported from a single Indian manufacturer. This is one of the first documented DEG outbreaks in which contaminated medications were imported rather than being domestically manufactured.”
AKI outbreaks associated with DEG contamination have been documented earlier in Panama, Nigeria, India and Haiti, said the report, adding that in the past incidents, “manufacturers have been suspected of substituting DEG for more expensive, pharmaceutical-grade solvents”.
The report pointed out that inadequate regulatory structures made the sale of medications from international markets an especially high-risk activity in low-resource settings. “Medications for export might be subject to less rigorous regulatory standards than those for domestic use. Simultaneously, low-resource countries might not have the human and financial resources to monitor and test imported drugs,” the report stated.
The syrups had reached Gambia from Haryana on June 21, 2022.
In July 2022, a paediatric nephrologist at Edward Francis Small Teaching Hospital in Gambia’s capital city of Banjul alerted the Ministry of Health (MoH), Gambia, to a cluster of AKI cases among children. After the MoH request, a CDC team comprising an epidemiologist, anthropologist, infectious disease physician and environmental health scientist reached Gambia on September 16, 2022.
By September 29, 2022, the MoH had identified 78 clinically suspected AKI cases. Among these, 66 (85 per cent) had died. Most patients (75 per cent) were aged less than two years and 60 per cent were males.
CDC, MoH and Field Epidemiology Training Program (FETP) investigators developed a standardised case report form to gather data about AKI patients. For this investigation, a confirmed case of paediatric AKI was defined as one suffering from anuria (no urine output).
Interviews with at least one caregiver of a sample of 27 patients were conducted. After combining data from these interviews and 52 medical record reviews, 59 case report forms were completed. “During the course of the illness, all patients experienced anuria and fever, 95 per cent experienced vomiting and 73 per cent experienced diarrhoea. Nearly one-half (48 per cent) experienced anorexia or reduced feeding,” said the report.
“Abnormal laboratory test results were received by 66 per cent to 100 per cent of patients, including impaired renal and liver function, thrombocytosis and mild to moderate anaemia. Fourteen patients underwent peritoneal dialysis and one patient underwent hemodialysis; all 15 patients who received dialysis died,” the report added.
The laboratory analysis of 23 medication samples conducted by the MoH and the WHO confirmed that four products from Maiden Pharmaceuticals contained DEG and EG, the report said.
On October 4, 2022, the MoH had suspended all imports from this manufacturer. The next day, the WHO issued a worldwide medical product alert for four syrup-based medications from Maiden Pharmaceuticals.
Request for joint inspection pending
The request of the State Drug Controller, Haryana, to the Drug Controller General of India (DCGI) with regard to the Gambia deaths for a joint inspection of the Maiden Pharma premises is pending
