MHRA warns parents not to use baby rectal catheters
In a new safety notice, the Medicines and Healthcare products Regulatory Agency, or MHRA, has told parents, carers and healthcare professionals not to use rectal catheters on babies. These products are often sold as gas and colic relievers, and they can be bought online or in shops without a prescription. If you are hearing about them for the first time, that matters. These are products families may come across while looking for relief from colic, constipation or trapped wind. The MHRA's advice is clear: do not use them in infants, and dispose of any you have already bought.
That warning may sound abrupt, so it helps to pause on who is saying it. The MHRA is the UK regulator that checks medicines and medical devices and decides whether the likely benefits are strong enough to justify the risks. When it issues a Device Safety Information notice, it is making a formal safety judgement that people should take seriously. **What this means:** this is not a rumour or a parenting fad being challenged. It is the public body responsible for device safety saying the evidence does not give enough confidence for these products to be used in babies.
After reviewing the available evidence and taking expert clinical advice, the MHRA said there is insufficient evidence that rectal catheters work as intended in infants. In plain English, that means there is not enough reliable clinical proof that these devices help with colic, gas-related discomfort or constipation in babies. That wording matters. 'Insufficient evidence' does not mean every use has been shown to cause harm. It means the case for benefit has not been made strongly enough, which is a serious problem when the patient is a baby and the device is being used on a very delicate part of the body.
The agency also raised concern about risk. It said the safety and benefits of these products remain uncertain, and experts considered the possibility of injury to a baby's bottom, including tearing or perforating the inside. Those terms may sound clinical, but the point is simple: if an injury like that happened, it could be very serious. The MHRA added that there have been no confirmed reports of serious injury so far. Even so, regulators do not have to wait for a long list of harmed children before acting when the benefits are unclear and the possible harm could be significant.
There is another concern here that can be easy to miss when you are focused on getting quick relief for a distressed baby. The MHRA said using these products could make it harder to spot an underlying condition that needs medical attention. In other words, a device meant to ease symptoms may also blur the picture of what is really going on. For families, that point is worth holding on to. Colic and digestive discomfort can be exhausting and upsetting, but they can also sit alongside other causes of pain or illness. That is one reason health agencies are usually cautious about over-the-counter fixes aimed at very young babies.
Dr Alison Cave, the MHRA's Chief Safety Officer, acknowledged that colic and digestive discomfort can be distressing for both babies and their families. Her message was not to dismiss that stress but to say that there is not enough clinical evidence to support the safety and effectiveness of rectal catheters in babies. So what should you do instead? The advice from the MHRA is to seek help from a healthcare professional and follow NHS guidance if you are worried about your baby. If you already have one of these products at home, the agency says it should be disposed of rather than kept for later use.
If a baby has a suspected side effect or there is a problem with a medical device, the MHRA says it should be reported through the Yellow Card scheme. That reporting system helps regulators spot patterns and decide when wider safety action may be needed. There is a broader lesson here too. A product can be easy to buy and still not have good enough evidence behind it, especially when it is marketed to anxious families looking for fast answers. The safest reading of this notice is also the simplest one: when it comes to infant health, 'sold in shops' is not the same as 'shown to work'.