Press release

Parents advised not to use unlicensed homeopathic teething products in infants and children

Parents of infants and young children should not use unlicensed homeopathic teething tablets or gels which are available to buy online due to the risk of side effects.

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Parents of infants and young children should not use unlicensed homeopathic teething tablets or gels which are available to buy online due to the risk of side effects, the Medicines and Healthcare products Regulatory Agency said today.

This advice follows a US Food and Drug Administration (FDA) investigation into homeopathic teething tablets and gels which could cause serious side effects such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation.

These particular products are made and supplied by manufacturers in the USA and are not licensed for use in the UK and are not known to be available in UK outlets. However the unlicensed products may be advertised on online shopping or pharmacy websites.

Parents should be reassured that products licensed in the UK are not affected. A list of homeopathic products licensed by the MHRA is below and these can continue to be used:

Authorisation Number Product Name Authorisation Holder Company Name
NR 01175/0184 TEETHA TEETHING GEL A NELSON AND COMPANY LIMITED
NR 01175/0387 NELSONS TEETHA TEETHING GRANULESBOOTS TEETHING PAIN RELIEF A NELSON AND COMPANY LIMITED
NR 08822/0250 CAMILIA ORAL SOLUTION BOIRON
NR 27776/0003 HELIOS ABC 30C PILLULES HELIOS HOMOEOPATHY LIMITED
PLR 00298/5826 WELEDA CHAMOMILLA 3X GRANULES WELEDA UK LIMITED

Herbal medicines granted a traditional herbal registration (THR) in the UK are not affected. THRs can be identified by the THR Certification Mark found on the pack. The following THR has been licensed by MHRA and can be continued to be used:

Authorisation Number Product Name Authorisation Holder Company Name
THR 16853/0076 ASHTON AND PARSONS INFANTS’ POWDERS ALLIANCE PHARMACEUTICALS LTD

The National Institute for Clinical Excellence (NICE) has produced a summary of the available evidence and guidance on how to manage symptoms of teething: http://cks.nice.org.uk/teething#!scenario The summary recommends that initial management should comprise self-care measures, such as gentle rubbing of the gum and allowing the child to bite on a clean and cool object. Paracetamol or ibuprofen suspension, used according to instructions, can be considered for infants 3 months of age or older.

MHRA Director of Licensing, Dr Siu Ping Lam said:

If you have given your child any unlicensed homeopathic products and they experience side-effects, you should contact your doctor for advice.

Anyone who has bought unlicensed homeopathic products online should not use them and return them to your pharmacy for disposal.

We advise members of the public not to buy unlicensed medicines online and have recently launched a campaign to help people purchase medicines via the internet safely. Read our eight top tips for buying medicines and devices safely online.

If your child has experienced a side effect to any medicine you should report these to us through our Yellow Card Scheme

Ends

Notes to Editor

  1. Please see link to the FDA warning
  2. Please see further information on the regulation of homeopathic products 3.Further information on our Fake Meds campaign
  3. MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk

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Published 7 October 2016
Last updated 19 October 2016 + show all updates
  1. Additional information about THR products.
  2. Added approved product
  3. First published.