See Names Of Cough Syrups That Has Killed Over 66 Children | READ MORE
The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria and the World Health Organisation (WHO), has issued warnings over some cough syrups killing children in the Gambia.
The identified syrups are; Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
According to a statement released by the Director General, NAFDAC Professor Mojisola Adeyeye, on Sunday in Abuja, the syrups are contaminated as analysis have shown that they have unacceptable amounts of diethylene glycol and ethylene glycol.
“Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury, which may lead to death.
“The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.
“All the batches of these products listed above should be considered unsafe,” Adeyeye said.
According to Adeyeye, though the syrups rampant in Gambia, are not registered by NAFDAC and therefore should not be in circulation in Nigeria, they might have penetrated other countrie through illegal markets, hence the need for the awareness.
“If you have these substandard products, please do not use them. If you or someone you know have used them or suffered any adverse reaction or event, you are advised to seek immediate medical advice from a qualified healthcare professional,” she added.
Adeyeye also encouraged healthcare professionals and consumers to report any suspicion of adverse drug reaction and substandard and falsified medicines to NAFDAC on 0800-162-3322 or to report any incident through the email: sf.alert@nafdac.gov.ng.
In the same vein, an alert released by WHO on their official website read;
Alert Summary
This WHO Medical Product Alert refers to four substandard products, identified in The Gambia and reported to WHO in September 2022. Substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore “out of specification”[1].
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.
Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.
Risks
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal
Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.
All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities.
The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.
Advice to regulatory authorities and the public
It is important to detect and remove these substandard products from circulation to prevent harm to patients.
WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised.
All medical products must be approved and obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional when in doubt.
If you have these substandard products, please DO NOT use them. If you, or someone you know, have used these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre.
National regulatory/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country. If you have any information concerning the manufacture or supply of these products, please contact WHO via rapidalert@who.int
