Menu
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)
Related UK National News Stories
Click here for the latest headlines.
23 May 2013
Charities Highlight Rise In Children Abusing Children
Children’s charities have warned that an increasing number of children are being abused by other children, adding that their helplines have seen a growing number of calls from children about sexual abuse.
Charities Highlight Rise In Children Abusing Children
Children’s charities have warned that an increasing number of children are being abused by other children, adding that their helplines have seen a growing number of calls from children about sexual abuse.
19 April 2012
Children's Society Warns Benefit Changes Could Leave Children Hungry
A children’s charity has warned that plans to simplify the welfare system could result in thousands of England's poorest children missing out on free school meals. The meals are linked to low-income benefits that are among those merging into a single Universal Credit in 2013.
Children's Society Warns Benefit Changes Could Leave Children Hungry
A children’s charity has warned that plans to simplify the welfare system could result in thousands of England's poorest children missing out on free school meals. The meals are linked to low-income benefits that are among those merging into a single Universal Credit in 2013.
28 July 2014
Domestic Abusers Are Let Off With A Slap On The Wrist - Labour
More than 10,000 domestic abusers are being let off with a "slap on the wrist", according to Labour's Shadow Home Secretary Yvette Cooper. In a speech in Birmingham she accused ministers of "downgrading action on violence against women". Labour obtained data from 15 police forces which confirmed 3,305 of 'community resolutions' were used last year.
Domestic Abusers Are Let Off With A Slap On The Wrist - Labour
More than 10,000 domestic abusers are being let off with a "slap on the wrist", according to Labour's Shadow Home Secretary Yvette Cooper. In a speech in Birmingham she accused ministers of "downgrading action on violence against women". Labour obtained data from 15 police forces which confirmed 3,305 of 'community resolutions' were used last year.
17 October 2014
Funeral Held For Mary Shipstone, Aged 7
The funeral has taken place of seven-year-old Mary Shipstone, who was murdered by her father at her home in Northiam, Sussex. The child was buried in a private service at St Mary's Church in the village.
Funeral Held For Mary Shipstone, Aged 7
The funeral has taken place of seven-year-old Mary Shipstone, who was murdered by her father at her home in Northiam, Sussex. The child was buried in a private service at St Mary's Church in the village.
14 October 2014
Woman And Children Found Dead In Stoke-on Trent
An investigation is underway following the discovery of the bodies of a woman and two children at a house in Stoke-on-Trent. Police say they made the discovery after being called to an address in Sherwin Road at about 18:35 on Sunday. A woman and two children were pronounced dead at the scene. No details of the victims have yet been released.
Woman And Children Found Dead In Stoke-on Trent
An investigation is underway following the discovery of the bodies of a woman and two children at a house in Stoke-on-Trent. Police say they made the discovery after being called to an address in Sherwin Road at about 18:35 on Sunday. A woman and two children were pronounced dead at the scene. No details of the victims have yet been released.
-
Northern Ireland WeatherToday:Dry, bright start this morning with best of sunshine in the west. Thickening cloud over Down and Antrim this morning with a few showers, extending westwards this afternoon. Lighter winds. Maximum temperature 16 °C.Tonight:Rather cloudy and mainly dry at first, then showery outbreaks of rain extending westwards to most places during the night, turning heavier towards morning. Light winds. Minimum temperature 8 °C.
