Exclusive-WHO says toxic syrup risk ‘ongoing’, more countries affected
By Jennifer Rigby
LONDON (Reuters) – There is an ongoing global threat posed by toxic cough syrups, the World Health Organization (WHO) told Reuters, saying it was now working with six more countries than previously disclosed to trace medicines for potentially deadly children.
The UN agency has already named nine countries where tainted syrups may have been sold, after the deaths of more than 300 children on three continents last year were linked to the drugs.
Rutendo Kuwana, WHO’s team leader for substandard and falsified medicines incidents, declined to name the six new countries the agency is working with, while investigations are still ongoing.
He warned that contaminated medicines could still be found for several years because adulterated barrels of an essential ingredient could remain in warehouses. The cough syrups and the ingredient, propylene glycol, both have a shelf life of about two years.
“This is an ongoing risk,” Kuwana said.
Unscrupulous actors sometimes replace propylene glycol with toxic alternatives, ethylene glycol and diethylene glycol, because they are cheaper, several pharmaceutical manufacturing experts told Reuters.
The alternatives are most commonly used in brake fluid and other products not intended for human consumption.
The WHO’s working theory is that in 2021, as propylene glycol prices rose, one or more suppliers mixed the cheaper toxic liquids with the legitimate chemical, Kuwana said. He did not say the whereabouts of the suppliers and added that murky supply chains made it difficult to prove.
Pharmaceutical manufacturers, including those alleged to have produced the tainted syrups that have been found so far, typically source ingredients from outside suppliers.
LIBERIA AND CAMEROON
Earlier this week, Nigeria’s regulator issued a warning about contaminated paracetamol syrups sold in Liberia, although no deaths were reported. The Nigerian regulator was testing the syrups, which have not been sold in Nigeria because Liberia has no testing facilities.
Last year WHO issued safety alerts for Indian-made products found in The Gambia and Uzbekistan, and this year in Micronesia and the Marshall Islands.
It also issued a warning last year for Indonesian-made syrups sold only domestically. Indonesian authorities say more than 200 children were likely poisoned by them.
Three Indonesian manufacturers PT Yarindo Farmatama, PT Universal Pharmaceutical Industries and PT AFI Farma have had their licenses revoked. A fourth, PT Konimex, said it has recalled all relevant products and its website says it has been cleared by the Indonesian regulator to sell new batches starting in December 2022. The Indonesian regulator has not responded immediately to a request for comment.
In January, WHO named four other countries it was working with including Timor Leste, Cambodia, Senegal and the Philippines to check whether any of the tainted syrups had reached their markets.
There is no current risk to the population in the WHO-nominated countries, Kuwana said, both because the contaminated medicines were pulled from the shelves and because they never reached the market in the first place.
Countries’ governments either confirmed this, said there was only a minimal risk, or did not respond to requests for comment.
WHO said it has also offered help to Liberia and Cameroon, which recently signaled they too may have contaminated cough syrup for sale.
Cameroon’s health regulator said in April it was investigating the deaths of six children linked to a cough syrup labeled Naturcold. The manufacturer indicated on the packaging is the Chinese Fraken Group, which did not immediately respond to requests for comment.
But Cameroon authorities said in a notice that the medicine was purchased from unauthorized sources and likely smuggled in. They did not respond to requests for more information.
Other manufacturers identified in the current wave of incidents are largely Indian. Two companies whose products have been linked to deaths have been shut down by local authorities: Maiden Pharmaceuticals, which sold syrups in The Gambia, and Marion Biotech, whose syrups went to Uzbekistan.
Naresh Kumar Goyal, the founder of Maiden Pharmaceuticals, told Reuters in December that his company has done nothing wrong in manufacturing the cough syrup. Marion Biotech did not respond to requests for comment.
In addition to these cases, Indian-made medicines supplied to the Marshall Islands and Micronesia have been recalled after Australian laboratory tests showing contamination prompted a WHO security alert. The manufacturer, QP Pharmachem, told Reuters earlier this year that its tests had found no problems.
The syrups contaminated in Liberia were manufactured by India’s Synercare Mumbai, according to the Nigerian regulator. The Liberian health regulator said it plans to incinerate the stock and will also recall two other Synercare products, as a precaution.
Synercare did not respond to a request for comment.
Since 2001, WHO has recommended not giving cough syrups to children under the age of 5, because it says there is limited evidence of their effectiveness or the side effects they can have.
There have also been at least five incidents in the past half-century in which acetaminophen and cough medicines were contaminated with deadly chemicals, in countries including India and Panama, although last year’s spate of deaths is the deadliest never registered.
WHO also urged all countries to step up surveillance and offered support to affected countries that lack the resources to test their own medicines.
“It’s certainly not over,” Kuwana said. “But we shouldn’t panic, as many countries are now proactive.”
(Reporting by Jennifer Rigby; additional reporting by Krishna N.Das in Delhi, Edward McAllister in Dakar, Stanley Widianto in Jakarta, Sumit Khanna in Ahmedabad, Sophie Yu in Beijing. Editing by Sara Ledwith and Michele Gershberg)
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