13 December 2018 - Deborah Wilkes
Teething gels for babies and children that contain the active ingredient lidocaine will be restricted to sale through pharmacies from 2019 in the UK.
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is reverse-switching the medicines from general-sale list (GSL) to pharmacy (P) status.
The move follows a review by the Commission on Human Medicines (CHM) which also recommended that the administration instructions and safety warnings for the medicines should be updated.
The MHRA said the medicines should only be used when non-medicinal options, such as a teething ring or massaging the gum, had not provided the necessary relief.
"Teething is a natural process and lidocaine-containing teething products, such as teething gels, should only be used as a second line of treatment after discussion with and guidance of a healthcare professional," added the MHRA.
The MHRA said sugar-free paracetamol or ibuprofen suspensions might also be considered for the relief of teething symptoms.
Benefits and risks
Sarah Branch, deputy director of the MHRA's Vigilance and Risk Management of Medicines Division, said an in-depth review of the benefits and risks of the products had shown there was a "lack of evidence of benefit to using teething gels".
Commenting on the risks, the MHRA said these were "very small given the wide usage of these medicines".
Ash Soni, president of the Royal Pharmaceutical Society, said pharmacists were "always a good first port of call" for any common conditions children developed.
John Smith, chief executive officer of the Proprietary Association of Great Britain (PAGB), said the industry was "pleased" that the MHRA had concluded products containing up to 1% lidocaine hydrochloride were appropriate for treating teething pain in children aged over five months.
The MHRA noted that oral lidocaine products approved for adults and other conditions such as mouth ulcers would remain GSL.
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