LONDON, Aug. 18 -- The government of the United Kingdom issued the following news:
The Medicines and Healthcare products Regulatory Agencyhas today issued a Device Safety Information (DSI) noticewarninghealthcare professionals,parentsand carersnot to userectal catheters(gasand colic relievers)on their babies.
These products aresometimes used by parents and caregivers to help with colic, constipation or trapped wind. They are available to buy online and in shops without a prescription.
Following a review of available evidence and expert clinical advice, the MHRA has concluded that there isinsufficientevidence that these devices workas intended. The MHRA is also concerned aboutthepotential risksassociated with their use.
TheMHRA is advising that parents,caregiversand healthcare professionals do not use or recommendthe use ofthese productsininfants, and that any products already purchased should be disposed of.
While there have been no confirmed reports ofserious injury, the safety and benefits of these productsremainuncertain.There are concernsthatusing these products could make it harder to detect underlying conditions that may require medical attention. Experts also considered the potential risk of injury to the bottom, including tearing or perforating the inside of an infant'sbottom, which could haveserious consequences.
DrAlison Cave, MHRA Chief Safety Officer,said:
"We understand that colic and digestive discomfort can be distressing for babies and their families.Weareadvisingagainst the use ofrectal catheters in babiesbecause there is not enough clinical evidencetosupport theirsafetyand effectiveness."
"Parents and caregivers should seek advice from a healthcare professional and follow the NHS guidance if they are concerned about their baby."
Anyone whoexperiences a problem with a medical deviceor suspects thattheirchild has had a side effect related to the use of rectal cathetersshould report itdirectly to theMHRA Yellow Card scheme.
Notes to editors:
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TheDevice Safety Information notice can be read here: Device Safety Information: All rectal catheters (gas and colic relievers)
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and areacceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
Disclaimer: Curated by HT Syndication.
