MHRA update: Oral lidocaine-containing products for teething in children

MHRA update: Oral lidocaine-containing products for teething in children

December 14, 2018

The MHRA have issued new guidance relating to the use of oral lidocaine-containing products for teething in children.

Following a review of the benefits and risks of oral lidocaine products, the Commission on Human Medicines (CHM) advised on measures to improve the safe use of these products for teething in children.

Following reports of medication errors received via the Yellow Card Scheme, measures recommended by CHM include:

  • Change of legal status of newly manufactured stock of oral lidocaine-containing products from general sale (GSL) to pharmacy (P).
  • Update and harmonisation of posology and safety warnings across all oral lidocaine products authorised for teething.
  • Restriction of the pack size of oral lidocaine products authorised for teething to a maximum of 10 grams.
  • 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.

Community pharmacy teams need to be aware of the change from GSL to P, new packaging bearing the ‘P’ logos will be available from early 2019. In the meantime, pharmacies are required to move the existing ‘GSL’ labelled packs behind the counter and only supply the products under the supervision of the pharmacist who will need to provide parents/carers with new instructions.

Newly packaged oral lidocaine-containing products are expected to be available in pharmacies from the beginning of 2019. 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), included with any last remaining GSL packs during the transition.

Products considered in the review: 

Lidocaine-containing products authorised for teething:

Product Name Lidocaine % (w/w) Product Licence Number
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 3 Months+   0.60%  PL 00014/0392
Calgel® Teething Gel   0.33%  PL 15513/0015
Dentinox® Teething Gel   0.33%  PL 00133/5010R

Lidocaine-containing products authorised in adults or for 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

Resources and questions regarding these changes can be found in the review.



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