New Delhi, May 27 (KMS): Another report from Gambia has concluded that 70 children died in the country last year due to acute kidney injury after they had consumed paediatric formulations contaminated with toxins, manufactured by an Indian drug maker. These toxins were diethylene glycol (DEG) and ethylene glycol (EG).
The report, which did a causality assessment of the deaths, is the fourth in the series to make such a conclusion. All these reports contradict the stand taken by the Indian government, which said that it found no contamination in its assessment of the products.
The causality assessment report, which has been prepared by international experts, says, “Based on the detailed review of 56 cases of AKI [acute kidney injury] in children in the Gambia DEG/EG poisoning could be confirmed as a cause of AKI and death in 22 children. For the remaining 34, DEG/EG poisoning also needs to be considered as likely cause in at least 30 [children] despite absence of confirmed exposure given the epidemiologic context, the absence of other identified causes, the notorious difficulty to assess medicine exposure in detail and the fact that two children in this group had autopsy findings suggestive of DEG/EG poisoning.”
In summary, “the causality assessment committee certified that the outbreak of acute kidney injury in children in Gambia is attributable to the medicines contaminated with DEG/EG.”
Thirty-eight products, or medicines made by manufacturers of other countries, were sent for testing. The report says except for four medicines made by Maiden Pharmaceuticals, none of the 34 were found to be contaminated. These 34 products that were found to not have EG and DEG were released for marketing on November 11, 2022, the report adds.
Besides these lab reports, a report from the US Centers for Disease Control 9 CDC) and a parliamentary report from the Gambia have also concluded that the deaths of these children were linked to the products of Maiden Pharmaceuticals.
The expert committee on causality assessment was led by professor Abdou Niang, a specialist in internal medicine at Senegal’s Cheikh Anta Diop University. The other members included an expert in toxicology from Senegal Toxicology Control Center, two in paediatrics and clinical pharmacology from Finland’s Clinical Toxicology Helsinki University Hospital and UK’s All Wales Toxicology Centre University Hospital, two in infectious diseases and epidemiology from the WHO, one each in neurosurgery, internal medicine, microbiology and pathology from Gambia’s Edward Francis Small Teaching Hospital, and one in cardiology from Gambia’s Bafrow Medical Center.
Earlier, the WHO had also refused to accept the findings of the Indian expert committee that claimed no toxins were found in the Maiden Pharmaceuticals products sent to Gambia and that there was no proof of link between the deaths and the medicines.
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