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NAFDAC raises alarm over existence of killer cough syrups from India

The National Agency for Food and Drug Administration and Control (NAFDAC) has raised an alarm over the existence of 4 dangerous and contaminated cough syrups linked to acute kidney injuries and children’s deaths in The Gambia.

The World Health Organisation (WHO) in its global alert on October 5, 2022, listed the 4 products as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, linking it to deaths of children in July, August, and September.

This was made known in a press briefing on Tuesday by the Director-General of NAFDAC, Professor Mojisola Adeyeye, where she said that the products are manufactured by an Indian company, Maiden Pharmaceuticals Limited, which had failed to provide guarantees about their safety.

Adeyeye stated that although these products identified in the Gambia are not yet registered by NAFDAC and as such should not be in circulation, she noted that they may have been distributed through informal markets, to other countries or regions, thereby making the agency increase its vigilance.

She implored importers, distributors, retailers, consumers, and stakeholders to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of substandard cough syrups.

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Toxic effects of the contaminated syrups, linked to 66 deaths

Adeyeye also listed the toxic effects of the contamination in the cough syrup including abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death. She said that the stated manufacturer of these products has not provided guarantees to WHO on the safety and quality of these products.

According to WHO, the four cold and cough syrups in question have been potentially linked with acute kidney injuries and 66 deaths among children in the Gambia.

See the full text of the press briefing by the Director General of NAFDAC on The Substandard (Contaminated) Paediatric Cough Syrups Circulating In Gambia

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What NAFDAC is saying

  • 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 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 has issued an alert to the public on Public Alert No. 039/2022 –  Alert on Substandard (contaminated) paediatric cough syrups circulating in the Gambia. This alert has been widely circulated on our website and all social media handles and sent to all healthcare providers on our database as well as professional bodies and associations in the medicine supply chain.
  • In addition, we have put appropriate measures in place to prevent the 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.
  • The National Agency for Food and Drugs Administration and Control (NAFDAC) is using these mediums 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.
  • According to the WHO report, laboratory analysis of samples of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

Product Details

The details of the substandard cough syrups are as follows;

Product Manufacture

Product Name

Maiden Pharmaceuticals Limited (Haryana, India)

· Promethazine Oral Solution,· Kofexmalin Baby Cough Syrup,

· Makoff Baby Cough Syrup

· Magrip N Cold Syrup

 

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