The Minister of Health, Dr Ahmad Lamin Samateh, has finally admitted and confirmed to the media, that the deaths of seventy children were as a result of the Acute Kidney Injury disease (AKI) outbreak.
Dr Samateh made these statements on Friday 21st July 2023, during the launching of the Presidential Task Force Report on the causes of death of seventy Gambian children, whose death is attributed to the consumption of toxic levels of Ethylene Glycol (EG) and Diethylene Glycol (DEG) found in four syrups namely, promethazine oral solution BP, Kofexmaline baby cough syrup, MakoFF baby cough syrup and MaGrip cold syrup.
Minister Samateh elaborated that AKI is a sudden onset of deteriorating function of the kidneys which manifests as Oliguria (diminished urination) or anuria (absent urination) and other symptoms such as oedema, confusion, nausea, vomiting, diarrhea, shortness of breath, coma etc.
"This is because the kidneys are damaged and unable to maintain the internal milieu of the body, leading to accumulation of toxic products of metabolism which becomes fatal in some cases. Acute Kidney Injury has many causes and among these are Escherichia Coli infection, severe dehydration which might be as a result of diarrhea and vomiting, nephrotoxic drugs and substances and malaria among others," he said. According to Dr. Samateh, the Ministry of Health was alerted on the 26th July 2022, on the increasing number of children presenting at the Edward Francis Small Teaching Hospital with signs of AKI, with many of them succumbing to the disease. He added that the Epidemiology and Disease Control Unit of the Ministry was instructed to swing into action to get to the root of the problem. Dr. Samateh said the World Health Organization (WHO) was contacted for support in handling the outbreak, and an Incident Management System was set up and Co-chaired by the Ministry of Health and WHO, to manage the situation.
"Since this phenomenon was unprecedented in this country, it was very difficult to ascertain at first, what was causing the Acute Kidney Injury (AKI). The Committee suspected that AKI could be caused by drug toxicity since paracetamol toxicity was identified as the cause of AKI in some countries in the past. The World Health Organization Country Office helped to send patient samples and samples of the drugs used by the patients to laboratories in Senegal, Ghana, France and Switzerland," he said. The Minister of Health said laboratory analysis confirmed that toxic levels of Ethylene Glycol (EG) and Diethylene Glycol (DEG) were found in four syrups namely, promethazine oral solution BP, Kofexmaline baby cough syrup, MakoFF baby cough syrup and MaGrip cold syrup, and said these are organic compounds found in certain products such as industrial solvents and anti-freeze and are used as raw materials in manufacturing polymers. He said accidental or intentional ingestion of DEG and EG products has been known to cause poisoning.
"The illegal use of DEG to replace glycerin or propylene glycol as a solvent in medication had been reported in some countries in the past.
All four of these products were manufactured by Maiden Pharmaceuticals in India and were imported to The Gambia by Atlantic Pharmaceuticals. Government immediately banned Atlantic pharmaceuticals who got their license withdrawn and their premises closed. This was followed by police investigations into their activities," he said. He said the Medicines Control Agency then sprang into action with series of steps to remove the drugs from circulation, which steps included a ban on the sale and consumption of all Maiden Pharmaceutical products in The Gambia. He added this was followed by a recall of all products from the drug outlets and households, and that the outbreak was controlled by November 2022, after the products were removed from circulation.
"We have never lost sight of the fact that sadly, 70 children died as a result of the outbreak. The AKI outbreak was a national tragedy. This was a very difficult moment for all of us and we wish to emphasize to the bereaved families of President Barrow's resolve and that of his government in addressing the issue. However, it was very important to establish the cause of the Acute Kidney Injury in a scientific way," he said. He said after reviewing the findings of the casualty assessment report and conducting series of interviews and reviewing numerous documents, the Presidential taskforce made series of findings and recommendations.
"The taskforce confirmed that the deaths can be conclusively linked to the four cough syrups imported by Atlantic Pharmaceuticals from Maiden Pharmaceuticals in India. The taskforce also investigated how these syrups were imported from India and distributed in the country. They learned that the affected medicines were not registered with the Medicines Control Agency, even though the Regulation requires all medicines to be registered before importation. The MCA has the legal responsibility to ensure all medicines and related products are submitted through an application for registration prior to importation," he said.
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Dr Samateh said the Taskforce found that there is an urgent need for a quality control laboratory to conduct proper testing on all medicines and related products imported into the country, adding although the statute authorized a National Laboratory years ago, the MOH failed to realise and establish this.
"One of the fundamental requirements of registration is that an applicant must submit a copy of a certificate of a qualified pharmacist and failure to submit the requirement will render the application invalid. All licensed importers registered with the Medicines Control Agency are expected to have met the aforementioned requirements," which requirement of the law he said is that the licensed pharmacist will serve as the supervising pharmacist working for/with the importers to provide professional advice to the importer, during the process of importation and distribution of medicines and related products.
