WHO says toxic syrup risk 'ongoing', more countries hit
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[June 17, 2023]
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 revealed to
track the potentially deadly children's medicines.
The U.N. agency has already named nine countries where tainted syrups
may have been on sale, after the deaths of more than 300 infants on
three continents last year were linked to the drugs.
Rutendo Kuwana, the WHO team lead for incidents with substandard and
falsified medicines, declined to name the six new countries the agency
is working with, while investigations are still underway.
He warned that contaminated medicines could still be found for several
years, because adulterated barrels of an essential ingredient may remain
in warehouses. Cough syrups and the ingredient, propylene glycol, both
have shelf-lives of around two years.
"This is an ongoing risk," said Kuwana.
Unscrupulous actors sometimes substitute propylene glycol with toxic
alternatives, ethylene glycol and diethylene glycol, because they are
cheaper, several pharmaceutical manufacturing experts told Reuters.
The alternatives are more commonly used in brake fluid and other
products not meant for human consumption.
The WHO's working theory is that in 2021, when prices of propylene
glycol spiked, one or more suppliers mixed the cheaper toxic liquids
with the legitimate chemical, Kuwana said. He did not say where the
suppliers were based, and added that obscure supply chains have made
proving this difficult.
Pharmaceutical manufacturers, including those alleged to have produced
the tainted syrups that have been found so far, typically source
ingredients from external suppliers.
LIBERIA AND CAMEROON
Earlier this week, Nigeria's regulator issued a warning about
contaminated paracetamol syrups sold in Liberia, although no deaths have
been reported there. The Nigerian regulator was testing the syrups,
which were not sold in Nigeria, because Liberia has no testing
facilities.
The WHO issued safety alerts last year for Indian-made products found in
Gambia and Uzbekistan, and this year in Micronesia and the Marshall
Islands.
It also issued an alert last year for Indonesian-made syrups that were
only sold domestically. Indonesian authorities say more than 200
children were likely poisoned by these.
Three Indonesian-based manufacturers – PT Yarindo Farmatama, PT
Universal Pharmaceutical Industries, PT AFI Farma – have had their
licences revoked. A fourth, PT Konimex, said it had recalled all of the
relevant products and its website says it was cleared by the Indonesian
regulator to sell new batches as of December 2022. The Indonesian
regulator did not immediately respond to a request for comment.
In January, the WHO named four other countries it was working with –
Timor Leste, Cambodia, Senegal and the Philippines – to track whether
any of the tainted syrups had reached their markets.
There is no current risk to the population in the countries the WHO has
named, Kuwana said, either because contaminated medicines had been
pulled from shelves or because they never reached the market in the
first place.
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The World Health Organisation (WHO) logo
is seen near its headquarters in Geneva, Switzerland, February 2,
2023. REUTERS/Denis Balibouse/File Photo
The countries' governments either
confirmed this, said there was only a minimal risk, or did not
respond to requests for comment.
The WHO said it has also offered help to Liberia and Cameroon –
which recently signalled that it too may have contaminated cough
syrups for sale.
Cameroon's health regulator said in April it was investigating the
deaths of six children linked to a cough syrup branded as Naturcold.
The manufacturer named on the packet is China's Fraken Group, which
did not immediately respond to requests for comment.
But the Cameroon authorities said in an alert the medicine was
bought from unauthorised sources and possibly smuggled in. They did
not respond to requests for more information.
Other manufacturers identified in the current spate of incidents are
largely Indian-based. Two companies whose products have been linked
to deaths have been shuttered by the authorities there: Maiden
Pharmaceuticals, which sold syrups to Gambia, and Marion Biotech,
whose syrups went to Uzbekistan.
Naresh Kumar Goyal, the founder of Maiden Pharmaceuticals, told
Reuters in December his company did nothing wrong in the production
of the cough syrup. Marion Biotech has not responded to requests for
comment.
Besides these cases, Indian-made medicines supplied to the Marshall
Islands and Micronesia have been recalled after Australian
laboratory tests showing contamination prompted a WHO safety alert.
The manufacturer, QP Pharmachem, told Reuters earlier this year that
its own tests had found no issues.
The contaminated syrups in Liberia were made by India's Synercare
Mumbai, according to the Nigerian regulator. The Liberian health
regulator said it plans to incinerate the stock and will recall two
other Synercare products as well, as a precaution.
Synercare did not respond to a request for comment.
NOT RECOMMENDED
Since 2001, the WHO has recommended against giving cough syrups to
children aged under 5, because it says there is limited evidence of
how effective they are, or what side-effects they may have.
There have also been at least five incidents in the last half
century when paracetamol and cough medicines were contaminated with
deadly chemicals, in countries including India and Panama, although
the spate of deaths last year is the deadliest on record.
The WHO has also urged all countries to step up surveillance and
offered support to concerned countries that do not have the
resources to test their own medicines.
"It's not over certainly," said Kuwana. "But we don't need to panic,
as a lot of countries are now being 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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