Advice for healthcare professionals:
- all oral lidocaine-containing products with an infant teething indication are becoming pharmacy medicines; newly manufactured products with updated instructions will be available only in pharmacies where advice on their correct use and on babies’ health can be given – see
- pharmacists should only recommend use of these products when local non-medicinal treatments such as a teething ring or massaging the gum have failed to provide sufficient relief
- if oral lidocaine-containing products are to be used, remind parents and caregivers to read the advice in the Patient Information Leaflet carefully, especially for dose and administration, and to seek medical attention if their child’s condition does not improve
- advise parents and caregivers that other lidocaine products authorised in adults or for other conditions such as mouth ulcers should not be used for treatment of infant teething pain
- sugar-free paracetamol or ibuprofen suspensions, administered according to the approved indication and dose for weight and age, may also be considered for the relief of teething symptoms
- report any suspected adverse drug reactions to lidocaine products via the Yellow Card Scheme
Review of oral lidocaine-containing teething products
The Commission on Human Medicines (CHM) has advised on measures to improve the safe use of lidocaine-containing products for teething in children. In an in-depth review of the benefits and risks of these products, CHM identified a number of reports of medication error received via the Yellow Card Scheme (see ). Most reports did not include an associated adverse event and were not thought to result in harm, but the committee recommended that the administration instructions should be improved and harmonised to ensure parents and caregivers received consistent advice on the safe use of these medicines in babies.
CHM recommended 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.
New measures: access to healthcare professional advice and new warnings and instructions
The legal status of newly manufactured stock of oral lidocaine-containing products indicated for infant teething is changing from general sale (GSL) to pharmacy (P).
This change means that oral lidocaine products for infant teething can only be sold in pharmacies where advice can be given by the pharmacist (see also Quick reference guide for pharmacists). Instructions for administration and safety warnings are being updated in the new patient information leaflet. Advice is being given to parents and caregivers to seek medical attention if their child’s condition does not improve and not to use more than one product containing lidocaine at the same time. We have produced a ( available) to help you discuss the new advice.
Oral lidocaine products that are approved in adults or in other conditions (eg, mouth ulcers) will remain GSL but should not be used in infants for teething because they have different approved dosing regimens. The Patient Information Leaflets and cartons of these oral lidocaine-containing products without a teething indication are being updated accordingly.
General advice about teething
Teething is a normal process, usually beginning at around 6 months of age. NICE recommends simple, self-care measures as first steps for relief of associated discomfort. These include gentle rubbing of the gum with a clean finger and allowing the child to bite on a clean and cool object. Pharmacists should advise parents and carers to only use oral lidocaine products when these non-medicinal methods do not provide necessary relief.
Sugar-free paracetamol or ibuprofen suspensions, administered according to the approved indication and dose for weight and age, can also be considered for the relief of teething symptoms.
Availability of updated medicines and advice
Updated oral lidocaine-containing products will be available in pharmacies from the beginning of 2019. Products with older packaging are no longer being manufactured. Pharmacists should provide parents and caregivers with the most up-to-date instructions (provided in Quick reference guide for pharmacists) or in the Patient Information Leaflets on EMC), including with any last remaining GSL packs during the transition.
Report suspected adverse drug reactions
Suspected adverse drug reactions to oral lidocaine-containing products should be reported via the Yellow Card Scheme, including medication error resulting in harm. For more information about why it is important to report Yellow Cards in babies and children and how you can support this further, see article in November 2018 Drug Safety Update.
Article citation: Drug Safety Update volume 12, issue 5: December 2018: 1.
This article has been published online on 13 December 2018, in advance of the rest of the December 2018 Drug Safety Update. This is to enable healthcare professionals and the public to receive consistent information on advice for lidocaine products for teething. The remainder of the December 2018 Drug Safety Update will be published the week commencing 17 December 2018.