Earlier this month, the director of the World Health Organization said ingredients in four cold and cough syrups made in India may have been linked to acute kidney injuries and the deaths of 66 children in The Gambia – and that the products may have been distributed to other countries.
Days later, authorities in India launched an investigation and halted all production at the company that made the tainted drug.
This week, authorities in Indonesia banned the sale of all cough syrups nationwide. They are now investigating the deaths of more than 130 people, mostly children, from acute kidney injuries this year. But so far there is no evidence of a connection with contaminated medicines, although contaminated cough syrups have been found in some children’s homes.
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Here’s what we know so far:
Where did the spoiled syrup come from?
The four drugs linked to the Gambia deaths were manufactured by Maiden Pharmaceuticals, a New Delhi-based company that exports drugs to developing countries.
WHO director Tedros Adhanom Ghebreyesus told reporters Oct. 5 that the agency was conducting an investigation. In a medical product alert issued the same day, the agency said analysis of the four drugs found “unacceptable” levels of diethylene glycol and ethylene glycol, two industrial chemicals that are toxic to humans and can cause serious injury or death in children. The next day, health authorities in The Gambia ordered a recall of the four tainted products.
Police in The Gambia later said the deaths of 69 children from acute kidney injuries were linked to the four cough syrups manufactured by Maiden Pharmaceuticals.
Last week, Indian authorities said they had halted all production at the company after discovering violations at its factory in Haryana state, outside New Delhi. The state drug agency said the tainted products sold in The Gambia were made at the Haryana factory in December 2021.
The story goes on
The Indian government formed a committee to investigate the tainted drugs and deaths in The Gambia. Vivek Goyal, the director of Maiden Pharmaceuticals, said the company is working with investigators.
Are the deaths in Indonesia related?
There is no evidence of that at this point.
This week, the Indonesian government banned all syrup-based drugs and said it was investigating the deaths of 133 people, mostly children, from fatal acute kidney injuries. Health Minister Budi Gunadi Sadikin said on Friday that cough syrup containing diethylene glycol and ethylene glycol was found in some houses where children had died.
But it wasn’t clear how many of the deaths, if any, were linked to tainted syrup. A 2020 scientific study states that while the epidemiological data on cases of acute kidney injury in Indonesia was limited, the condition was a common problem in intensive care units of the country’s hospitals.
Penny K. Lukito, the head of Indonesia’s Food and Drug Administration, said Oct. 15 that no products made by Maiden Pharmaceuticals, including the four drugs linked to the Gambia deaths, have been registered in Indonesia. It is very unlikely that an imported drug can be legally sold in Indonesia without registration.
India has said Maiden’s tainted produce was only sent to The Gambia, but the WHO has said it may have been distributed to other countries.
Why are these two chemicals so harmful?
Diethylene glycol and ethylene glycol are clear, colorless, and syrupy alcohols used in antifreeze and other industrial applications. Unlike the type of alcohol that people are safe drinking, they are potentially deadly even in small amounts.
The effects of ingestion can include headaches, abdominal pain, vomiting, diarrhea, and inability to urinate. The chemicals can also damage the liver, kidneys, and central nervous system.
The primary way medical professionals treat people who have ingested the chemicals is by giving them a drug, fomepizole, that stops the body from metabolizing them, said Leo Schep, a toxicologist in New Zealand.
“But you have to get in early” to avoid serious complications, he added. “Otherwise you end up on slippery ice.”
There are precedents for such scandals.
Diethylene glycol has historically been used as a cheap substitute for glycerin, a sweet syrup that’s a safe ingredient in many over-the-counter medications.
This has sometimes led to mass poisoning. At least 84 children died in Nigeria in 2009 after taking a childhood medicine containing diethylene glycol.
In India in 1998, 33 children died after ingesting a contaminated cough suppressant. Eight children also died that year after ingesting paracetemol syrup. Both of these products contained diethylene glycol.
Could something so deadly happen in the United States?
It’s unlikely.
After contaminated drugs killed more than 100 people in the United States in 1937, Congress passed legislation that improved the federal government’s ability to regulate drugs.
Schep said that because of this law and other regulations, the risk of further mass poisoning from contaminated drugs in the United States is low. The same goes for Australia, New Zealand and the European Union as they all have similar laws, he added.
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