A joint investigation by the US Centers for Disease Control and Prevention (CDC) and Gambian health officials suggested a strong link between the deaths of many children in the Gambia and the consumption of Indian-made cough syrup, which was said to be contaminated.
In October, the World Health Organization (WHO) issued an alert stating that four cough syrups manufactured by India-based Maiden Pharmaceuticals Ltd. sold and shipped to The Gambia, were substandard and related to the deaths of many children in The Gambia.
A CDC report released on Friday said: “This 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.”
“Patients with DEG poisoning can experience a range of signs and symptoms, including altered mental status, headache, and gastrointestinal symptoms; however, the most consistent manifestation is AKI, characterized by oliguria (low urine output) or anuria, progressing over 1-3 days to renal failure (indicated by elevated serum creatinine and blood urea nitrogen), read the report.
According to the CDC, the Gambian Ministry of Health contacted them last August to help characterize the disease (many cases of acute kidney failure and childhood deaths), describe the epidemiology and identify possible causative factors and their source.
The report also found that in previous DEG outbreaks, manufacturers were suspected of substituting DEG with more expensive pharmaceutical solvents.
“Among reports of AKI associated with DEG-contaminated medical products, this is the first in which DEG-contaminated medications were imported into a country, rather than being domestically manufactured,” it said.
It was also found that medicines intended for export may be subject to lower regulatory standards than medicines intended for home use.
“Simultaneously, low-resource countries might not have the human and financial resources to monitor and test imported drugs, ” it said.
Union State Health Minister Bharati Pravin Pawar, in his response to the Lok Sabha on February 3, said that after testing, the cough syrup samples were found to be of standard quality.
The samples tested negative for diethylene glycol (DEG) and ethylene glycol (EG), Pawar said in a written response to the question.
