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Homeopathic teething products investigated over links to 10 baby deaths in America are being sold in Australian pharmacies, including one at Melbourne’s Royal Children’s Hospital.
The US Food and Drug Administration warned last month that Hyland’s homeopathic teething tablets contained inconsistent amounts of the “toxic” substance belladonna and posed a risk to children.]
It urged parents to dispose of the tablets and seek medical care immediately if children experienced symptoms, including seizures, difficulty breathing or agitation.
Australia’s Therapeutic Goods Administration investigated Hyland’s teething tablets and gel after the FDA issued a safety alert for both products in October last year.
But it found no quality issues and said no action would be taken.
Hyland’s website lists numerous pharmacies that stock its teething products in Australia, including Terry White Chemists and Priceline.
Fairfax Media found Hyland’s teething products for sale at Drew Wood Pharmacy at the Royal Children’s Hospital on Thursday.
The FDA launched an investigation in the US last year after 10 babies died and many others had adverse reactions to the product.
It requested manufacturer Standard Homeopathic Company recall the products, but the company refused.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” FDA Center for Drug Evaluation and Research director Janet Woodcock said.
“We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”
Australian Skeptics member Peter Hogan, who has been investigating the sale of Hyland’s teething products in Australia, said he was concerned TGA testing was inadequate.
“I was quite shocked that the [pharmacy at the] Royal Children’s Hospital was selling the stuff,” he said.
“I’m concerned parents may be gambling with their babies’ health.”
Mr Hogan questioned whether more testing was required after the FDA found inconsistent levels of belladonna between batches.
He said Australian Skeptics president Chris Guest had written to the Drew Wood Pharmacy with their concerns, but had not heard back.
A TGA spokeswoman said samples had been tested from two batches of the tablets and no problems were identified.
She said one batch of the teething gel was tested and the level of belladonna did not warrant safety regulatory action.
“However, based on further information from [the] FDA we are considering whether testing of more samples will be useful,” she said.
“Consumers are encouraged to be cautious in purchasing homoeopathic teething products and to talk to their health professional before using them for infants or children.”
Belladonna, also known as deadly nightshade, is a plant that has been used in cosmetics and herbal medicine since the middle ages.
It is also used as a recreational drug because of the hallucinations it can produce.
It comes after a Choice investigation found one in three Australian pharmacists recommend alternative medicines that have little or no scientific evidence of working.
Four Corners aired its own investigation into the complementary medicine industry on Monday night, which found seven out of every 10 Australians take some form of vitamin or supplement.
The TGA released a consultation paper on Tuesday seeking feedback into an industry review.
Pharmacist Drew Wood was not aware of the FDA warning or TGA testing. The pharmacy sells the gel and tablets about once a month.
A Royal Children’s Hospital spokeswoman said it would not be informed of what was stocked in the private pharmacy.
The hospital issued a release about the safety alert in November.
A Hylands media release issued in October said it was discontinuing the distribution of its teething products in the US with “much sadness” after the FDA’s safety warning.
Hyland’s Australian distributor, Kadac, has been contacted for comment.