Device Safety Information: All rectal catheters (gas and colic relievers): Do not use in infants, including for the treatment of colic, gas-related discomfort or constipation
Rectal catheters (gas and colic relievers) 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 to purchase online and in-store, without a prescription or oversight from a healthcare professional. These are also known to be used by parents and caregivers to provide relief from colic and constipation in infants, although this is not the intended use of the device.
Do not use rectal catheters in infants, including for colic, gas-related discomfort or constipation. Stop using these products immediately and dispose of any unused devices. The MHRA does not recommend their use because there is insufficient clinical evidence to demonstrate effectiveness, and the potential risks associated with these products are unknown. Rectal catheters (gas and colic relievers) are single-use, hollow, plastic tubes with a stopper that are inserted into the infant’s rectum (bottom) and are commonly used by parents and caregivers to attempt to provide relief from gas-related discomfort. If parents or caregivers have any concerns about their baby, they should speak to their healthcare professional.
Advice for Healthcare Professionals to Provide to Patients:
- Do not use rectal catheters (gas and colic relievers) in your child, including to treat colic, gas, bloating, or constipation and dispose of any unused products
- The risks of injury to the infant’s bottom (rectum), bleeding, pain or perforation (a hole in the bowel) associated with use of rectal catheters in infants are unknown
- Please refer to NHS guidance for the management of colic
- If you are concerned about your baby, it’s best to speak to your health visitor, call NHS 111, see a GP, or call 999 in an emergency
- If you suspect that your child has had a side effect related to the use of rectal catheters report it to the MHRA via the Yellow Card website
