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Lidocaine teething gels to be reclassified from GSL to P medicine

The MHRA said pack sizes of lidocaine teething gels will be restricted to 10g
The MHRA said pack sizes of lidocaine teething gels will be restricted to 10g

Lidocaine-containing teething gels will be reclassified from a general sale list (GSL) to a pharmacy (P) medicine, the medicines watchdog has announced.

The Medicines and Healthcare products Regulatory Agency (MHRA) said yesterday (December 13) that packaging with the P logo will be available in pharmacies “from the beginning of 2019”.

Lidocaine-containing teething gels are being repositioned as a treatment “only used when non-medicinal options do not provide necessary relief”, the MHRA explained.

Pack sizes will be restricted to 10g and products with older packaging are no longer being manufactured, the MHRA said.

The Pharmaceutical Services Negotiating Committee advised pharmacies to move existing GSL-labelled packs behind the counter, and only supply them under the supervision of a pharmacist – who can inform parents of the updated guidance.

Review of benefits and risks

The change in legal status follows a MHRA review into the benefits and risk of the products, which concluded that pharmacists were best placed to provide guidance on options for teething symptoms, “including when symptoms could suggest more serious conditions that need medical assessment”, the watchdog said.

The review “identified a number of reports of medication error received via the yellow card scheme”, it added. “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.”

First-line non-medicinal treatments for teething include “gentle rubbing of the gum with a clean finger and allowing the child to bite on a clean and cool object”, the MHRA said.

Royal Pharmaceutical Society president Ash Soni said pharmacists are “always a good first port of call for any common condition [a] child develops”.

Lidocaine-containing products authorised for teething:

Product
Lidocaine %
Anbesol Teething Gel
1%
Anbesol Liquid
0.9%
Bonjela Teething Gel
0.33%
Bonjela Junior Gel
0.5%
Boots Teething Gel 3 Months+
0.6%
Calgel Teething Gel
0.33%
Dentinox Teething Gel
0.33%

Source: MHRA

2 Comments
Question: 
Do you agree with MHRA switching the medicine status of lidocaine-containing medicines?

Daniel Pharmacist, Community pharmacist

Is licodaine similar to lidocaine? (see top of MHRA product table)

Thomas Cox, Editorial

Thank you for flagging that Daniel, the typo has been rectified. 

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