My HPRA: Register

HPRA advises parents not to source unlicensed homeopathic teething products online

News Category: 3rd party

Date: 17/10/2016

Unlicensed products could pose safety risks


The HPRA today advised parents that unlicensed homeopathic teething tablets or gels should not be used as they could pose safety risks for young infants and babies. 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. However, the unlicensed products may be advertised and available to buy online.

The HPRA states that a U.S. Food and Drug Administration (FDA) investigation into a range of these products concluded that they may cause serious side effects including, seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation. 

If any parents have sourced these products then the HPRA advice is that they should stop using them immediately and dispose of them safely. If a child has been given any unlicensed homeopathic teething products and is experiencing side-effects then medical advice should be sought.

This announcement does not apply to the two homeopathic teething products that are permitted by the HPRA to be available on the Irish market. Both products are manufactured and marketed by Nelsons:

• Teetha Teething Granules 
• Teetha Teething Gel 

The HSE has published helpful information for parents about teething. 

ENDS

FOR FURTHER INFORMATION:
Weber Shandwick PR     (01) 679 8600
Siobhan Molloy / Rachel Galligan     086 817 5066 / 087 791 9901

NOTE TO EDITORS:
Link to the U.S. FDA announcement.
 
 

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