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WHO warns against deadly cough syrup

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Ghebreyesus

The World Health Organisation has warned that a deadly batch of cough mixture connected to the deaths of dozens of children in Gambia may have been distributed to other countries.

The agency on Wednesday, placed a medical product alert on cough and cold syrups made by India’s Maiden Pharmaceuticals Ltd., which have been potentially linked to acute kidney injuries and 66 deaths among children in the tiny West African nation, WHO Director General Tedros Adhanom Ghebreyesus said during a media briefing.

Four contaminated Maiden products were found in a laboratory analysis to contain “unacceptable amounts of diethylene glycol and ethylene glycol,” the WHO said. Tedros added that the global health body is conducting further investigations with the company and Indian regulators, while recommending countries remove the treatments from circulation.

The drugs are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

The manufacturer of these products is Maiden Pharmaceuticals Limited in Haryana, India, and the company has not provided guarantees to WHO on the safety and quality of these products.

According to WHO, laboratory analysis of samples of each of the four products confirms 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.

WHO advised that all batches of these products should be considered unsafe until they can be analysed by the relevant national regulatory authorities.

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It warned that the products are unsafe and their use, especially in children, may result in serious injury or death.

“It is important to detect and remove these substandard products from circulation to prevent harm to patients,” the global health body warned in an official alert on Wednesday.

WHO requested increased surveillance and diligence within the supply chains of countries and regions likely to be affected by the products. Increased surveillance of the unregulated market is also advised.

All medical products are advised to be approved and obtained from authorised suppliers. The products’ authenticity and physical condition should be carefully checked. And advice should be sought through a healthcare professional when in doubt.

National regulatory and health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country.

The deaths shine a spotlight on India’s $42 billion drugmaking industry, which has been heavily promoted by Prime Minister Narendra Modi as the “pharmacy of the world.

India supplies many of the cheap, generic drugs sold in American pharmacies and hundreds of countries globally. But treatments produced in the South Asian nation have been the source of multiple manufacturing scandals in recent years, including the export of tainted heart pills.

Closely-held Maiden Pharma has been making and supplying medical products for more than 30 years and has a presence across multiple countries in Africa, Asia, Eastern Europe, the Middle East, and Russia, according to its website.

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