The World Health Organisation on Wednesday issued an alert over four paediatric cough syrups manufactured in India, warning that they would potentially harm the health of those consuming the product, and could be linked to the death of 66 children in The Gambia.
The four cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup — are manufactured by Maiden Pharmaceuticals Limited in Haryana.
The WHO said, "To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products."
Why did WHO issue the alert?
The WHO said that the four products, all meant for children, contained "unacceptable amounts" of diethylene glycol and ethylene glycol. This was found after laboratory tests of samples of all the products.
In a media address, WHO director Tedros Adhanom Ghebreyesus said, "WHO has today issued a medical product alert for four contaminated medicines identified in The The Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children. The loss of these young lives is beyond heartbreaking for their families."
He suggested that while the products have been only found in The Gambia so far, they could have reached markets in other countries. "WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients."
WHO's advisory, it said, was directed to all the batches of these products.
Diethylene glycol and history of poisoning
This isn't the first time deaths due to the presence of diethylene glycol in cough syrups have been reported. Diethylene glycol contaminated medicines have been an issue for years. Not just in India, deaths connected to diethylene glycol contaminated medical syrups have been reported in Panama, Bangladesh, Nigeria and the United States as well.
The US Department of Health and Human Services, the Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER) issued guidance for the medical industry in 2007 to test glycerin for diethylene glycol, which they termed as "poison". The report said, "FDA has received and continues to receive (most recently in October 2006) reports about fatal DEG poisoning of consumers who ingested medicinal syrups, such as cough syrup or acetaminophen syrup, that were manufactured with DEG-contaminated glycerin."
The Centre for Disease Control and Prevention (CDC), had said in 2009 the Nigerian Federal Ministry of Health had received reports of "13 cases of unexplained acute renal failure among children from a hospital in Lagos state". These patients had been exposed to a teething medication which, the Nigerian authorities discovered, had been contaminated by diethylene glycol.
In Panama, over a hundred people died from Diethylene glycol poisoning in Panama in 2006. The New York Times said in a report in 2007, that it was after a Chinese company exported the chemical as 99.5% pure glycerin. The report said that in 1992, Bangladesh had found the poison in seven brands of medicine.
More recently in India, 12 children died in Jammu's Udhampur in 2020 from consuming poisoned cough syrup from the brand Coldbest-PC. The Hindu had reported at the time that deaths due to glycol poisoning had happened in India multiple times before — in 1973 14 children had died in Chennai, in 1986 14 patients had died in Mumbai and 33 children died in 1998 near New Delhi.
Diethylene glycol can cause renal failure, affect the liver and the central nervous system and even be fatal.
The WHO alert also said, "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."
Diethylene glycol is a derivative of ethylene glycol, which also has similar effects on the human body when ingested.
How does diethylene glycol find its way into medicines?
In the above cases, while some cases of diethylene glycol had been through contaminated glycerin, it was also found to have been used instead of propylene glycol to make the medicines. Diethylene glycol, also known as DEG, is often found in low-grade or adulterated medicines, chemicals to make medicines or other products.
Mint reported in 2021, diethylene glycol looks very similar to propylene glycol and glycerine, which is what may prompt unethical sellers of these chemicals to mix them.
In 2007, when diethylene glycol was found to be used in fake Colgate toothpaste in the US, Reuters reported that it is used sometimes illegally as a sweetener or thickening agent.