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Teething tablet fears prompt "urgent investigation" by TGA

EXCLUSIVE

PARENTS are being warned not to use homeopathic teething gels and tablets after they were linked to 10 deaths in the United States, as the Australian regulator investigates the products.

The Therapeutic Goods Administration has confirmed it has begun "urgent testing" of the range, aimed at calming distressed infants.

A TGA spokesperson said the drug regulator was urging parents "not to use the product while investigations are being conducted".

Manufacturer Hyland's has pulled the tablets and gels from shelves in US after the Food and Drug Administration warned the death of 10 children may be linked to the products.

The FDA - the American equivalent of the TGA - told parents to seek urgent medical help if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after using the products.

The link between the homeopathic teething products and the deaths remains under review by the FDA.
 

The homeopathic teething tablets remain on sale in Australia, despite the company removing them from sale in the US.
The homeopathic teething tablets remain on sale in Australia, despite the company removing them from sale in the US.

In Australia, just as in the US, these products have avoided the kind of scrutiny applied to other medicines because they are a homeopathic remedy.

The FDA did not require the company to issue a recall on the products, although Hyland's voluntarily removed the items from sale.

The products remain for sale in pharmacies across Australia.

In 2010, the FDA received reports of illness in children who used the products was consistent with belladonna toxicity. At the time it also found the teething tablets had "inconsistent" amounts of belladonna.

Belladonna, also known as "deadly nightshade" is the active ingredient in the Hyland's products.

In a letter to its customers, Hyland's wrote that it would stop selling its teething gels and tablets in the US after the FDA's warning against their use.

The products are now subject to an "urgent investigation" by Australia's drug regulator.
The products are now subject to an "urgent investigation" by Australia's drug regulator.

The company maintains its products are safe to use, but added that parents with concerns should consult their doctor, and read the labels carefully.

In a statement, Hyland's wrote it "has not been made aware of any of the data" in relation to issues caused by its products.

"The fact is that we have not been made aware of any medical or statistical evidence to support a causal link between homeopathic teething tablets and adverse outcomes at this point," it wrote.

Hyland's has been sought for comment.

Topics:  baby drugs editors picks homeopathic parenting teething therapeutic goods association


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