Wednesday, February 16, 2011

Berhati-hati dengan BONJELA


DOCTORS are calling for mandatory warnings on teething gels after children were hospitalised with potentially life-threatening poisoning.

The authors of a study conducted by two Sydney hospitals and two New Zealand hospitals, published in the Medical Journal of Australia, found that chronic salicylate intoxication could occur in children using over-the-counter teething gels, even at intakes close to the recommended doses.

Symptoms of such poisonings include gastrointestinal problems, hyperventilation, tremor and memory lapses, and the risk of death.

In Britain, the ingredient salicylate was removed from Bonjela teething gel after a 2002 study by the Commission on Human Medicines.

In Australia and New Zealand, several teething gels marketed to infants, including Bonjela, still contain salicylate and do not have warning labels.


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Some products recommend applying as much as a third of a tube every 24 hours, which the study's authors say equates to more than two 15g tubes a week.

The Therapeutic Goods Administration (TGA) considers teething gels to be therapeutic products, so the study's authors, including Sydney Children's Hospital pediatric intensivist Gary Williams and Prince of Wales Hospital consultant pediatrician Caroline Meadows, recommend that they be subject to the requirements of other over-the-counter medication, such as aspirin, and include warnings.

Dr Williams said parents should not assume that just because teething gels were marketed to children and available over the counter, they were perfectly safe.

"Teething can be disruptive and there is no doubting that ... but here is a commonly used solution that is widely thought of as being completely benign and one needs to be aware that that is not necessarily the case and that there is a safety issue here," Dr Williams said.

He said that parents would be better off using teething rings that had been cooled in the fridge as there was no scientific evidence of any beneficial effect of salicylate.

A spokeswoman for the NSW Poisons Information Centre, based at The Children's Hospital at Westmead, said calls to the centre in relation to teething gels were either about children who had accidentally ingested the contents of a tube, or parents who had used the product on children younger than the recommended age.

Two children had been referred to hospitals after calls to the centre's hotline last year, she said.

A TGA spokeswoman said the authority would consider extra warnings on the gels.

"Parents and carers are reminded to always use the product according to product instructions," she said.

In 2009, the TGA investigated links between the use of teething gels containing salicylate and Reye's syndrome, a potentially fatal disease that causes fatty liver and brain damage, after a study was published in the British Medical Journal.

The investigation found the study case was more likely a result of salicylate intoxication than Reye's syndrome.


Info produk Bonjela di Malaysia dari laman web Biro Pengawalan Farmaseutikal Kebangsaan... Ia mengandungi salicylate

Product Detail Information for MAL19910207X
Product Information :
Product Name
:
BONJELA
Holder Name
:
RECKITT BENCKISER (M) SDN. BHD.
Address
:
LEVEL 5, MENARA UAC NO. 12, JALAN PJU 7/5 MUTIARA DAMANSARA
:
47800
:
PETALING JAYA
:
SELANGOR
:
MALAYSIA
Manufacturer Name
:
RECKITT BENCKISER HEALTHCARE (UK) LTD
Address
:
DANSOM LANE, EAST YORKSHIRE, HULL HU8 7DS,
:
UNITED KINGDOM
Ingredients Information :
No.
Substance Name
1CETALKONIUM CHLORIDE
2CHOLINE SALICYLATE

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