DEG-contaminated cough syrups led to AKI and death in many children in Gambia
USA: Syrup-based medications contaminated with diethylene glycol (DEG), a chemical often used in antifreeze, is the probable cause of acute kidney injuries (AKIs) and deaths of 66 young children in Gambia in 2022, according to CDC researchers.
Gambia's Ministry of Health and the World Health Organization (WHO) conducted laboratory analysis of 23 medication samples and confirmed that four imported syrup-based medications contained ethylene glycol and diethylene glycol.
Parsa Bastani of the CDC's Epidemic Intelligence Service and Center for Global Health and the group reported that a large cluster of acute kidney injury cases affecting children in The Gambia in 2022 was linked with case fatality rates >80%.
"The implicated syrup-based pediatric medications administered to patients were imported from a single Indian manufacturer," the group detailed in the Morbidity and Mortality Weekly Report. The group stated that this is one of the first documented DEG outbreaks in which contaminated medications were imported rather than domestically manufactured.
In July 2022, a pediatric nephrologist alerted Gambia's Ministry of Health to a cluster of AKI cases in young children. The WHO and CDC were called to help characterize the illness and identify exposures.
Seventy-eight children had been identified with clinically suspected AKI by September 29, and 66 died. Among these patients, 60% were boys, and 75% were younger than two years.
The investigators gathered information from medical record reviews and caregiver interviews, and 59 case report forms were completed. It comprised 76% of the 78 cases reported to Gambia's MoH and 88% of the 67 patients with a symptom onset date.
Key findings from the analysis were as follows:
- A confirmed case of pediatric AKI was defined as anuria (no urine output) of unknown etiology in a child aged eight years and younger, persisting for 24 hours or more, from June 21 to September 29; 56 of the 59 patients met the case definition.
- Of these 56, 54% experienced fever as their first symptom, 50% experienced vomiting, and 34% had diarrhea or loose stools. All patients experienced anuria and fever; 95% had vomiting, 73% had diarrhoea, and 48% had anorexia or reduced feeding.
- The median interval from symptom onset to anuria was five days, and among the patients who died, the median interval from onset of anuria to death was six days.
- Abnormal lab results occurred in 66% to 100% of patients, including impaired renal and liver function, thrombocytosis, and mild to moderate anaemia.
- Among 26 caregivers interviewed, all reported that the children had taken over-the-counter or prescription syrup-based medications, including acetaminophen, before the onset of anuria.
- In eight of the 14 interviews where caregivers identified the manufacturer name of at least one medication the child had taken, one international manufacturer that produced a syrup-based medication was identified.
The import of all medications from the manufacturers was suspended by the Gambia's MoH on Oct. 4, 2022, and all healthcare providers were alerted of the possible contamination. On October 5, the WHO issued a worldwide medical product alert for the four medications. In collaboration with other organizations, the MoH conducted a house-to-house recall collection of these products and all promethazine, paracetamol, and cough syrups.
Joshua Schier of CDC and colleagues wrote, "such poisonings are nothing new; more than 14 mass poisonings with DEG have been reported in 14 countries over the last 80 years, often affecting children." The perspective was published in the New England Journal of Medicine.
"There is no clarity on the root causes of medication-associated diethylene glycol mass poisonings (MDMPs). However, DEF continues to sporadically appear in medications that normally contain appropriate excipients, such as pharmaceutical grade glycerin and propylene glycol," they stated.
DEG has many industrial uses because it is an effective solvent for water-soluble chemicals and is commonly used in antifreeze, brake fluid, fuel, lubricant, and wallpaper stripper. It is odourless, colourless, clear, viscous, and sweet.
Bastani's group noted that "inadequate regulatory structures make the sale of medications from international markets an especially high-risk activity in low-resource settings."
"MDMPs are a recurring public health problem, but guidance already exists regarding the identification of affected ingredients and final products that are likely to cause a mass poisoning," Schier and team concluded. "Following this guidance is critical to preventing MDMP-associated illnesses and deaths."
Reference:
1) Bastani P, Jammeh A, Lamar F, et al. Acute Kidney Injury Among Children Likely Associated with Diethylene Glycol–Contaminated Medications — The Gambia, June–September 2022. MMWR Morb Mortal Wkly Rep 2023;72:217–222. DOI: http://dx.doi.org/10.15585/mmwr.mm7209a1
2) Schier J, et al "Medication-associated diethylene glycol mass poisoning -- A preventable cause of illness and death" N Engl J Med 2023; DOI: 10.1056/NEJMp2215840.
