The Medicines and Healthcare products Regulatory Agency has
today issued a Device Safety Information (DSI)
notice warning healthcare
professionals, parents and carers not to
use rectal catheters (gas and colic
relievers) on their babies.
These products are sometimes 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
is insufficient evidence that these devices
work as intended. The MHRA is also concerned
about the potential risks associated with their
use.
The MHRA is advising that parents, caregivers and
healthcare professionals do not use or recommend the use
of these products in infants, and that any
products already purchased should be disposed of.
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. Experts also considered the potential risk of injury
to the bottom, including tearing or perforating the inside of an
infant's bottom, which could have serious
consequences.
Dr Alison Cave, MHRA Chief Safety
Officer, 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.
Anyone who experiences a problem with a medical
device or suspects that their child has had a side
effect related to the use of rectal catheters should report
it directly to the MHRA Yellow Card
scheme.
Notes to editors:
