Unlicensed homeopathic products for teething babies could cause seizures and breathing difficulties, the regulatory authority for medicines and health products has warned.
The Health Products Regulatory Authority (HPRA) has advised parents that unlicensed homeopathic teething tablets or gels that are made in the US 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 US and are not licensed for use or retail sale in Ireland,” said the HPRA.
“However, the unlicensed products may be advertised and available to buy online,” it added.
The HPRA warning follows a similar caution by the US Food and Drug Administration (FDA), which said that potential side-effects from the products include seizures, breathing difficulties, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, and 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,” the HPRA added.
The authority further said that its warning does not apply to Nelson’s Teetha Teething Granules or Teetha Teething Gel, both of which are cleared by the HPRA for sale in Ireland.
The FDA first warned about the potential side- effects of homeopathic teething products in 2010, when it advised that Hyland’s Teething Tablets “may pose a risk to children”.
Its testing of the product found that it contained a small amount of belladonna, “a substance that can cause serious harm at larger doses”, the FDA said.
“For such a product, it is important that the amount of belladonna be carefully controlled.
“FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna,” the administration said at the time.
“In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.
“The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps,” the administration warned.
In a renewed warning issued last month, the FDA said it is “also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children”.
“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
“We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives,” said Ms Woodcock.
The FDA further said that it has been analysing adverse reactions to homeopathic teething products since the concerns around Hyland’s Teething Tablets arose in 2010.
The authority said it is investigating the issue and is currently testing a number of teething products.
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