Oral lidocaine-containing products for infant teething will no longer be available off the shelf. In a drug safety alert issued yesterday (December 13), the Medicines and Healthcare products Regulatory Agency (MHRA) announced that the legal status of newly manufactured stock of oral lidocaine-containing products indicated for infant teething is changing from general sale to pharmacy sale only.
The Commission on Human Medicines (CHM) has advised on measures to improve the safe use of lidocaine-containing products for teething in children.
The decision follows an in-depth review of the benefits and risks for these products by the MHRA CHM. The CHM identified a number of reports of medication error received via the Yellow Card Scheme related to these products. Most reports did not include an associated adverse event and were not thought to result in harm, but the committee concluded that “pharmacists were best placed to provide guidance to parents and caregivers on options for teething symptoms, including when symptoms could suggest more serious conditions that need medical assessment”.
Instructions for administration and safety warnings are being updated in the new patient information leaflet. Updated oral lidocaine-containing products will be available in pharmacies from the beginning of 2019. Products with older packaging are no longer being manufactured.