Cough syrups warning as 66 children die in Gambia
A child taking syrup.
What you need to know:
- One of the four, used for babies, and which was linked to the deaths of 66 children in The Gambia was withdrawn from the Kenyan market last year.
- Promethazine, the drug used as an alternative to Piriton, was being imported from India.
- The drug manufactured by Maiden Pharmaceuticals was withdrawn because of its obsolete properties.
The World Health Organisation (WHO) has warned against the use of four cough syrup brands.
One of the four, used for babies, and which was linked to the deaths of 66 children in The Gambia was withdrawn from the Kenyan market last year.
Promethazine, the drug used as an alternative to Piriton, was being imported from India.
The drug manufactured by Maiden Pharmaceuticals was withdrawn because of its obsolete properties. It was available by prescription only and was used for paediatric patients.
According to the Kenya Essential Medicines List, Promethazine was replaced by Midazolam.
“This drug was used as an alternative to Piriton, but because there were better alternatives, we replaced it. We no longer import it,” said Pharmacy and Poisons Board Chief Executive Officer Fred Siyoi.
Dr Siyoi has instructed surveillance teams to be on the lookout in case there are some batches that are still being sold in the market.
WHO issued an alert against the Indian-made cough and cold syrups, saying that they may be linked to the deaths of 66 children in The Gambia.
Dozens of children started having acute kidney problems in July this year in the West African country.
The deaths confounded medics before a pattern emerged — dozens of patients younger than five were falling ill three to five days after taking a locally sold paracetamol syrup.
“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,” the organization said, adding that laboratory analyses 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,” the global health regulator said in an official brief while explaining that substandard medical products fail to meet either quality standards or specifications and are, therefore “out of specification”.
According to the WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products, 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.”
On the suspect products, the experts warned: “The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.”
The Indian government has commenced investigations into the four cough syrups manufactured by the Haryana-based pharmaceutical firm.
A source at the Ministry of Health told the Nation in an exclusive telephone interview that WHO had informed the Drugs Controller General of India (DCGI) about the contaminated cough syrups a week ago and India’s Central Drugs Standard Control Organisation had started investigating the pharmaceutical firm and testing samples.
