Urgent information – oral lidocaine-containing teething products from: GSL to P reclassification

Superintendent update on oral lidocaine-containing teething products reclassification from GSL to P

Dear Superintendent,

Oral lidocaine-containing products for use in teething have been reclassified from a status of General Sales List (GSL) to Pharmacy-only (P) medicine by the Medicines and Healthcare products Regulatory Agency (MHRA). The 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.

The MHRA has produced the following guidance/resources to help pharmacists and pharmacy teams in complying with this rescheduling:

• MHRA drug safety alert
• MHRA quick reference guide for pharmacists
• MHRA parent/carer information sheet
• MHRA Public Assessment Report

The NPA Pharmacy team has produced a poster to help pharmacy teams to recognise affected products.

Advice for pharmacists

All oral lidocaine-containing products licensed for treating infant teething pain will now only be available from pharmacies where advice on their correct use and on babies’ health can be given. The National Institute for Health and Care Excellence (NICE) Clinical Knowledge Summaries on teething recommends simple, self-care measures. Furthermore, all suspected adverse drug reactions should be reported via the Yellow Card Scheme.

When advising parents/carers on treatment options for their infant during teething:

• Recommend use of non-medical options such as teething ring or massaging the gum
• A suitably licensed lidocaine-containing products may be recommended if non-medical options do not give the child sufficient relief
  • Remind parent/carer to read the patient information leaflet (PIL) carefully, especially the dose instructions and advise them to seek medical attention if no improvement is seen
  • Parents/caregivers must not use more than one lidocaine-containing product at any given time
  • New instructions for lidocaine teething gels will now read: “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 3 hours. Do not use more than 6 times in one day (24 hour period)”
• Parents/caregivers should not use other lidocaine-containing products licensed for other conditions (for example, mouth ulcers), or for adults, to treat infant teething pain — such products remain as GSL; however, safety warnings will be including to act as a reminder that these should not be used in a child for teething
• Ibuprofen/paracetamol sugar-free suspensions may be recommended in accordance with their licensed indication and dose (which is dependent on age and weight) for pain and/or mild raised temperature

For further information please contact the NPA Pharmacy team on 01727 891800 or email pharmacyservices@npa.co.uk.

Kind regards,

Leyla