NAFDAC calls for vigilance over killer cough syrup
By Felicia Nwosu
The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians to guard against the use of four substandard and contaminated cough syrups identified as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip Cold Syrup.
According to the agency, these syrups have been linked to the death of 66 children in Gambia. The agency, therefore, called for total vigilance by all to avoid the use or administration of such cough syrup on children.
This was disclosed by Professor Mojisola Adeyeye, the Director-General of NAFDAC in Abuja. The DG revealed that a laboratory analysis of samples of the four products, confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
“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.
The director-general added that the substandard products were unsafe and that their use, especially in children, might result in serious injury or death. She said that the four products were already identified in The Gambia and might have been distributed, through informal markets, to other countries or regions. She, therefore, reaffirmed and warned that the products are not registered by NAFDAC and should, therefore, not be in circulation.
Adeyeye called for synergy among stakeholders such as importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard cough syrups.
The NAFDAC boss charged that all medical products must be obtained from authorised/licensed suppliers, adding that their authenticity and physical condition must be carefully checked. The director-general also advised members of the public in possession of the listed products to discontinue their sale or use and submit their stock to the nearest NAFDAC office.
“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/event, you are advised to seek immediate medical advice from a qualified healthcare professional,” she cautioned.
Adeyeye also urged all to take active role in the fight against substandard products while encouraging healthcare professionals and consumers to report any suspicion of adverse drug reaction, substandard and falsified medicines to NAFDAC on 0800-162-3322.
“The public is also advised to report any incident through this email: [email protected].
Implication of product flops on brands: Product flops among pharmaceutical companies across the continent is growing at an alarming rate, the worst is that children are always at the receiving end. Such scenario always places such a brand in the bad book of consumers and leads to its instant oblivion. It reduces a brand market positioning and equity at the same time for a long time, as it may never correct such a costly mistake. No matter how big such a brand is, there is the failure and inability to establish itself well and persist in the market as a result of bad history which will continue to hurt its relationships with business partners and consumers.
Its implication sometimes goes beyond the withdrawal of the product from the market but to total closure of the company.Recall in 2008-2009, when about 84 children died in Nigeria after taking “My Pikin Baby Teething Mixture”, a syrup for teething pain, which Nigeria’s Health Ministry officials said that a batch of the medicine that went on in November of that year contained diethyleneglycol, an industrial solvent and an ingredient in antifreeze and brake fluid. The company that produced the toxic syrup, Barewa Pharmaceutical Company Limited, was closed down by the court and all of its assets seized.
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