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STEER CLEAR OF BONJELA
Recent advice on the use of Bonjela for children aged
under 16 is the latest in a number of releases by the
Medicines and Healthcare Products Regulatory Agency
(MHRA) so far this year relating to children’s medicines.
This is a precautionary measure only
and there are no new safety concerns
The drug safety agency issued a ‘precautionary alert’
about Bonjela and Bonjela cool mint as the gel contains
salicylate salts. The Times reports that these have
the same effect on the body as aspirin, which is not
recommended for children under the age of 16.
Says the MHRA: “This is a precautionary measure
only and there are no new safety concerns. The
advice is being introduced due to a theoretical risk
these products could increase the possibility of a
child developing Reye’s syndrome – a rare but
serious condition.” Reye’s syndrome is a very rare
condition that causes liver and brain damage.
The exact cause of the condition is unknown but
previous viral infection, such as flu or chickenpox
and exposure to aspirin may contribute to
developing the condition.
There have been no confirmed cases of Reye’s
syndrome associated with the gels although the
MHRA has received three suspected Adverse Drug
Reactions (ADR) reports in association with the use
of the gels but none have confirmed Reye’s syndrome.
The MHRA is keen to point out that parents should
not be worried if they have already given their child
the gel. MHRA Director of Vigilance and Risk
Management of Medicines, Dr June Raine said:
“Any risk from these oral gel products is theoretical.
We are not aware of any confirmed cases, but when
there are alternatives available, any risk is not worth
taking. The new advice is to stop using these
products in children and young people under 16,
and to use alternative treatments.”
A number of options are available to treat pain for
teething and mouth ulcers. Dental gels are available
that contain a local anaesthetic or mild antiseptic
without the salicylate salts.
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