Key Summary
- The MHRA has advised parents, caregivers and healthcare professionals not to use these products in infants, and dispose of any products already purchased.
- These products are available without prescription, and used to help babies with colic, constipation or trapped wind.
- There are concerns that these products could make it harder to detect underlying conditions that may require medical attention.
The Medicines and Healthcare products Regulatory Agency has issued a device safety information (DSI) notice warning against the use of rectal catheters (gas and colic relievers) for babies following a review of available evidence and expert clinical advice.
Rectal catheters are single use, hollow, plastic tubes with a stopper that are inserted into the infant’s rectum and are commonly used by parents and caregivers to attempt to provide relief from gas-related discomfort.
These products are available without prescription, and can also be purchased online.
The MHRA has concluded that there is insufficient evidence that these devices work as intended and they also pose potential risks.
The regulator has advised parents, caregivers and healthcare professionals not to use these products in infants, and dispose of any products already purchased.
While there have been no confirmed reports of serious injury, the safety and benefits of these products remain uncertain.
There are concerns that using these products could make it harder to detect underlying conditions that may require medical attention.
They may delay diagnosis of serious gastrointestinal conditions, such as bowel obstruction or volvulus, by temporarily alleviating symptoms like gas without addressing the root cause.
Experts also considered the potential risk of injury to the infant, which could have serious consequences.
MHRA Chief Safety Officer Dr Alison Cave said: “We understand that colic and digestive discomfort can be distressing for babies and their families. We are advising against the use of rectal catheters in babies because there is not enough clinical evidence to support their safety and effectiveness.”
“Parents and caregivers should seek advice from a healthcare professional and follow the NHS guidance if they are concerned about their baby.”
If anyone suspects that their child has had a side effect related to the use of rectal catheters, they should report it to the MHRA Yellow Card scheme.
