How cough syrup gets poisoned
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[March 10, 2023]
(Reuters) - The global market for children’s over-the-counter
cough, cold and allergy remedies in 2022 was worth about $2.5 billion,
according to market research firm Euromonitor.
These medicines combine active ingredients such as paracetamol (known as
acetaminophen in the United States) to reduce fever with a syrup made
from glycerin or propylene glycol that is safe, sweet and easy to
swallow.
In Gambia, imported cough syrup for children was found by global health
officials to be contaminated with two highly toxic substances: ethylene
glycol (EG) and diethylene glycol (DEG). Both can be a byproduct of
making propylene glycol, said Dr Chaitanya Kumar Koduri, director of
regulatory engagement at U.S. Pharmacopeia (USP), a non-profit that
helps set drug-making standards globally.
Manufacturers making propylene glycol for pharmaceutical use must purify
it to remove any toxins, Kumar Koduri said. International standards
allow only trace amounts of EG and DEG in medicines: not more than 0.10%
of weight per volume, or 0.10g per 100ml of the syrup.
All the substances have similar properties. But while propylene glycol
is non-toxic, DEG and EG are extremely harmful. When ingested, they lead
to kidney failure and ultimately death without speedy treatment,
pathologists say.
How lethal the dose is depends partly on the weight of the person who
takes it. Children, being smaller, are more vulnerable than adults.
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A logo is pictured at the World Health
Organisation (WHO) in Geneva, Switzerland, December 14, 2022. To
match Special Report HEALTH-COUGHSYRUP/ REUTERS/Denis Balibouse
Mix-ups can happen due to human
error, said Kumar Koduri. But in the past, industrial grade
propylene glycol, or even pure DEG or EG have been substituted by
suppliers or manufacturers because they are cheaper.
EG and DEG can cost less than half the price of propylene glycol,
according to two websites selling the chemicals.
In the 1990s, nearly 90 children in Haiti and more than 200 children
in Bangladesh were killed by DEG in paracetamol syrups. More
recently, children have died in separate incidents in Panama, India
and Nigeria.
Global guidelines drawn up by the World Health Organization have
been tightened since, including urging manufacturers to do more
tests of their ingredients and finished products. But it is up to
individual countries to draft laws and enforce them, at both the
point of production and consumption.
(Reporting by Jennifer Rigby in London and Edward McAllister in
Banjul; Additional reporting by Natalie Grover in London; Edited by
Michele Gershberg and Sara Ledwith)
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