WHO urges ‘immediate action’ after deaths from children’s cough syrups

The World Health Organization urgently appealed for countries to prevent, detect and respond to cases of substandard and falsified medical products, citing recent reports of instances of children’s cough syrups with confirmed or suspected contamination.

“Over the past four months, countries have reported on several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG),” said the WHO.

“The cases are from at least seven countries, associated with more than 300 fatalities in three of these countries.”

The WHO said most fatalities are young children aged less than five.

The contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal, even taken in small amounts, and should never be in medicines.

Among the countries cited by the WHO are Gambia, Indonesia and Uzbekistan.

For Gambia, the four products are Promethazine oral solution, baby cough syrup Kofexmalin, baby cough syrup Makoff, and cold syrup Magrip N. The manufacturer of these products is Maiden Pharmaceuticals Limited of Haryana, India.

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Regarding Indonesia, the eight products are Termorex syrup (batch AUG22A06 only), Flurin DMP syrup, cough syrup Unibebi, paracetamol drops Unibebi Demam, paracetamol syrup Unibebi Demam, paracetamol drops (manufactured by PT Afi Farma), paracetamol syrup (mint) (manufactured by PT Afi Farma) and Vipcol syrup.

The two products named for Uzbekistan are AmbronoL and DOK-1 Max syrups. The manufacturer of both products is Marion Biotech Pvt. Ltd of Uttar Pradesh, India.

“To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” said the WHO, noting its medical product alerts were rapidly circulated to the national health authorities of all the 194 member states.

The medical product alerts requested the detection and removal of contaminated medicines from circulation in the markets, increased surveillance and diligence in countries and regions’ supply chains likely to be affected, and immediate notification to the WHO on delivery.

As the incidents are not isolated, the WHO urged critical stakeholders engaged in the medical supply chain to take “immediate and coordinated action.”

The WHO called on regulators and governments to detect and remove from their respective markets any substandard medical products identified in the WHO medical alerts as potential causes of death and disease.

The world health body called on those responsible for ensuring that all medical products in their respective markets are approved for sale by competent authorities and obtainable from authorized/licensed suppliers.

The WHO also called on manufacturers of medicines to only purchase pharmaceutical grade excipients from qualified and bona fide suppliers and to conduct comprehensive testing of supplies before use in manufacturing finished products.