Lidocaine teething gels will be reclassified from general sale (GSL) to pharmacy-only medicines (P), the Government has revealed.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced last week (13 December) that oral lidocaine-containing products for infants will be only available in pharmacies from early 2019.
In addition, pack sizes for products authorised for teething will now be restricted to 10g and products with older packaging no longer manufactured.
The measures follow a Government review that highlighted the lack of evidence of benefits and risks of using these products in babies before considering non-medicinal alternatives. Similar products approved for adult use will not be affected by the changes, the MHRA said.
Pharmacists ‘best placed’
In the review, the Government’s medicines advisors the Commission on Human Medicines (CHN) said that pharmacists are ‘best placed to provide guidance to parents and caregivers on options for teething symptoms’, especially if they suggest a serious condition that requires medical assessment.
The CHN added that teething gels should only be dispensed as ‘second line of treatment’ after self-care measures such as teething rings or massaging the gums have failed to provide relief to the child.
The review said: ‘The number of accidental exposure, therapeutic error and overdose events among reports, National Poisons Information Service (NPIS) enquiries, and the wider literature demonstrates that these products could be difficult to use correctly, without adequate advice, putting patients at risk of potential harm.’
‘There are no robust data providing convincing evidence of efficacy for oral lidocaine products in the treatment of teething in children.
The Pharmaceutical Services Negotiating Committee (PSNC) said that in the meantime pharmacists are required to move existing GSL-labelled packs behind the pharmacy counter pharmacists.
First port of call
Responding to the news, Royal Pharmaceutical Society (RPS) president Ash Soni said that pharmacists are always ‘a good first port of call for any common condition’ children can develop.
He continued: ‘It’s natural for parents to be concerned if their baby is experiencing discomfort with sore gums when teething.
‘Your local pharmacist can provide parents and caregivers of teething babies with expert advice and recommend the best course of treatment.’