Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) on Tuesday raised alarm over the use of four cough syrups linked to acute kidney injuries and children’s deaths in The Gambia.
NAFDAC said although the drugs are not expected to be in Nigeria – as it has not been ratified by the agency – Nigerians should stay vigilant as it “may have been distributed, through informal markets.”
NAFDAC Statement read in part: On the 5th of October 2022, the World Health Organization (WHO) issued a global alert for over four (4) cough syrups – warning they could be linked to acute kidney injuries and the children’s deaths in July, August, and September in The Gambia.
Interviews conducted on bereaved parents in The Gambia by health authorities and law enforcement agencies revealed how their children are not able to pass urine after being given the syrups. As their condition worsened, efforts to save their lives were fruitless which has resulted in the death of over 66 children. This is a worrisome development that once again beams a searchlight on the essence of effective regulation and control of medical products.
As a member of the WHO Programme on International Drug Monitoring and following our active participation in the WHO member state mechanism on substandard and falsified medical products, NAFDAC is leaving no stone unturned in ensuring that these products do not cause harm to our people. As part of our regulatory controls, NAFDAC have issued an alert to the public on the Public Alert No. 039/2022 – Alert on Substandard (contaminated) paediatric cough syrups circulating in Gambia. This alert has been widely circulated on our website and all social media handles and sent to all health care providers on our database as well as professional bodies and association in the medicine supply chain.
In addition, we have put appropriate measures in place to prevent entry of these spurious products from the various ports of entry and have activated our internal surveillance mechanisms to mop up these products from the supply chain pipeline if they are ever found.
These suspected medical products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – were manufactured by an Indian company, Maiden Pharmaceuticals, which had failed to provide guarantees about their safety.
The National Agency for Food and Drugs Administration and Control (NAFDAC) is using these medium to further notify healthcare providers and awaken the consciousness of the public on these four substandard products, identified in The Gambia and reported to WHO in September 2022.
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
