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23/04/2009
Ulcer Gel Warning For Under-16s
Children under the age of 16 should not be given the ulcer treatments Bonjela and Bonjela Cool mint gel, due to health risks, a watchdog has today warned.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued the alert on oral pain relief gels containing salicylate salts, which have been linked to an incurable condition Reye's syndrome.
This is due to salicylate salts having the same effect on the body as aspirin which is already contraindicated in children and young people under the age of 26.
The MHRA said the move was a "precautionary" measure after it received three reports of serious adverse drug reactions in children linked to the use of oral gels containing the substance - including Bonjela. However, Reye’s syndrome was not confirmed in any of the three children.
In a further four cases children experienced vomiting or diarrhoea after using Bonjela for teething pain, but all made a full recovery.
"This is a precautionary measure only and there are no new safety concerns," the Agency said in a statement.
"The advice is being introduced due to a theoretical risk that these products could increase the possibility of a child developing Reye’s syndrome – a rare but serious condition.
"There are a number of options and alternative treatments for pain associated with teething and mouth ulcers. If parents, carers or young people are unsure how best to treat these problems they should ask a GP, health visitor, dentist or pharmacist."
MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine said this new advice brings these products into line with others containing aspirin.
"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. For infants with teething there is helpful advice in the Department of Health’s Birth to Five publication."
Reye’s syndrome is a rare but potentially fatal condition that causes damage to many of the body’s organs. In particular it causes swelling of the brain, and problems with fat in the liver.
The initial symptoms include persistent vomiting, listlessness, loss of energy, and drowsiness.
Without treatment this can progress to extreme irritability, agitation, delirium, and coma.
(JM/BMcc)
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued the alert on oral pain relief gels containing salicylate salts, which have been linked to an incurable condition Reye's syndrome.
This is due to salicylate salts having the same effect on the body as aspirin which is already contraindicated in children and young people under the age of 26.
The MHRA said the move was a "precautionary" measure after it received three reports of serious adverse drug reactions in children linked to the use of oral gels containing the substance - including Bonjela. However, Reye’s syndrome was not confirmed in any of the three children.
In a further four cases children experienced vomiting or diarrhoea after using Bonjela for teething pain, but all made a full recovery.
"This is a precautionary measure only and there are no new safety concerns," the Agency said in a statement.
"The advice is being introduced due to a theoretical risk that these products could increase the possibility of a child developing Reye’s syndrome – a rare but serious condition.
"There are a number of options and alternative treatments for pain associated with teething and mouth ulcers. If parents, carers or young people are unsure how best to treat these problems they should ask a GP, health visitor, dentist or pharmacist."
MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine said this new advice brings these products into line with others containing aspirin.
"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. For infants with teething there is helpful advice in the Department of Health’s Birth to Five publication."
Reye’s syndrome is a rare but potentially fatal condition that causes damage to many of the body’s organs. In particular it causes swelling of the brain, and problems with fat in the liver.
The initial symptoms include persistent vomiting, listlessness, loss of energy, and drowsiness.
Without treatment this can progress to extreme irritability, agitation, delirium, and coma.
(JM/BMcc)
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