The TGA has issued a warning over homeopathic teething tablets which may contain belladonna alkaloids
The TGA has issued a warning over homeopathic teething tablets which may contain toxic amounts of belladonna alkaloids.
The authority ordered all Hyland’s Baby teething tablet products to be withdrawn from the market after an investigation by the FDA in US found inconsistent amounts of the toxic substance in the product which could vary from what was listed on the label.
A third Hyland’s product, a teething gel, was not affected by the recall, but wa been voluntarily withdrawn by the distributor, Kadac.
“While the TGA had tested samples of these products supplied in Australia and found no quality issues, Kadac is now recalling the tablets as a precautionary measure due to the potential safety risk that belladonna alkaloids can pose to children,” the TGA said in a statement.
“The effects of belladonna can be unpredictable and could cause serious health problems,” the TGA said.
The FDA raised the alarm about homeopathic teething products last year after an investigation found 400 reports of adverse events, including 10 deaths.
Hyland’s said in a statement that all its manufactured and sold teething medicines met the company’s safety limit tests and all tested product had been well within an established safety threshold.
Some homeopathic products, including the Hyland’s teething products, were not required to be on the Australian Register of Therapeutic Goods and were not assessed by the TGA before being sold in Australia. However, those products were still required to meet other Therapeutic Goods Act quality and safety provisions, the TGA said.
