The Medicines and Healthcare products Regulatory Agency (MHRA) have issued new advice for the use of oral lidocaine-containing products for teething in children. All oral lidocaine products licensed for teething will become Pharmacy only medicines.
Updated risk minimisation measures
Additional new risk minimisation measures are also being introduced:
- Change of legal status of newly manufactured stock of oral lidocaine-containing products from general sales (GSL) to pharmacy (P)
- Update and harmonisation of posology and safety warnings across all oral lidocaine products licensed for teething
- Restrictions of the pack size of oral lidocaine products for teething to a maximum of 10g
- Re-positioning of oral lidocaine products as second-line, after non-pharmacological treatments
- Update to oral, over-the-counter lidocaine products licensed in children for other indications and oral lidocaine products licensed in adults, to carry a warning against use in teething.
The products considered as part of the MHRA review are:
| Product Name | Lidocaine % (w/w) | Product Licence Number |
|---|---|---|
| Lidocaine-containing products for teething | ||
| Anbesol ®Teething Gel | 1.00% | PL 16853/0126 |
| Anbesol® Liquid | 0.90% | PL 16853/0128 |
| Bonjela® Teething Gel | 0.33% | PL 00063/0048 |
| Bonjela® Junior Gel | 0.50% | PL 00063/0657 |
| Boots® Teething Gel 3Months+ | 0.60% | PL 00014/0392 |
| Calgel® Teething Gel | 0.33% | PL 15513/0015 |
| Dentinox® Teething Gel | 0.33% | PL 00133/5010R |
| Lidocaine-containing products for adults and other indications | ||
| Anbesol® Adult Strength Gel | 2.00% | PL 16853/0127 |
| Boots® Mouth Ulcer Gel | 0.60% | PL 00014/0150 |
| Iglu® Gel | 0.66% | PL 00173/0186 |
| Iglu® Rapid Relief Gel | 0.66% | PL 00173/0406 |
| Medijel ® Gel | 0.66% | PL 00133/5000R |
Advice for Pharmacy teams
Updated oral lidocaine-containing products will be available in pharmacies from the beginning of 2019. The remaining GSL products will not be withdrawn but pharmacies will only be able to sell them on the advice of the pharmacist. Existing stock should be moved to behind the counter and only supplied with counselling on the new administration instructions.
Parents and carers should be advised that old packaging and product information leaflets will not reflect the updated information and pharmacists can provide parents and carers with the most up-to-date Patient Information Leaflet (PIL) available from the electronic medicines compendium.
Advice for parents and carers
The MHRA concluded that there is a lack of evidence of the benefit to using products containing lidocaine for teething before considering non-medicinal options. The current National Institute for Health and Care Excellence (NICE) advise simple self-care measures should be used as first line measures to relieve the discomfort associated with teething:
- Gentle rubbing of the gum with a clean finger.
- Allowing the infant to bite on a clean and cool object, such as a chilled teething ring or a cold wet flannel.
In addition paracetamol or ibuprofen suspension, administered according to the approved indication and dose, can be used for infants three months and over if required.
If parents or carers choose to use oral lidocaine-containing teething products, pharmacists should advise them of the updated advice about how much gel to apply and how often the gel should be applied:
Apply a pea sized blob of gel (see circle shown in the patient information leaflet) to a clean fingertip and spread gently onto the sore area of the gum. If necessary, repeat the dose after three hours. Do not use more than six times in one day (24 hour period)
The legal status of lidocaine-containing products licensed for other indications such as mouth ulcers or in adults has not changed but they will be clearly labelled with a warning ‘Not suitable for treatment of teething in children’. These products can continue to be administered according to the approved indication and dosage regimen.
An information leaflet for parents and carers has been produced by the MHRA and can be downloaded here.
The full MHRA Drug Safety Update is available here.
MHRA have produced a quick reference guide to support pharmacists when discussing these changes with parents. This can be downloaded here.