My HPRA: Register

Unlicensed homeopathic teething products

Notice type: Warning

Date: 17/10/2016

 Parents of infants and young children should not use unlicensed homeopathic teething tablets or gels which may be available to buy online due to the risk of side effects. This advice follows notice of an ongoing U.S. Food and Drug Administration (FDA) investigation into a range of these products which concluded that they may cause serious side effects.

Product name or type:
Unlicensed homeopathic teething tablets or gels

Active Substance:
Various

Authorisation Holder:
N/A

Target Audience:
Parents of infants and young children, health stores and pharmacies.

Problem Or Issue:
The FDA investigation highlighted potential side effects associated with the use of these products such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation.

The products in question are made and supplied by manufacturers in the U.S. and are not licensed for use or retail sale in Ireland.

This alert does not apply to the two homeopathic teething products (Nelsons Teething Granules and Nelsons Teething Gel) that are permitted by the HPRA to be available on the Irish market.  

If parents do have these products they should stop using them and dispose of them safely. If a child has been given any unlicensed homeopathic product and is experiencing side effects medical advice should be sought.

Any side effects thought be associated with use of these products may be reported to the HPRA. Please see further details on how to report suspected side effects including a link to our online report form. 

Further Information:
Press release: HPRA advises parents not to source unlicensed homeopathic teething products online

U.S. FDA warns against the use of homeopathic teething tablets and gels


 

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