It was found that homeopathic teething products being investigated over links to at least 10 baby deaths in the US are being sold in Australian pharmacies, including one at�Melbourne’s Royal Children’s Hospital.
The US Food and Drug Administration has issued a warning last month that�Hyland’s homeopathic teething tablets contained inconsistent amounts of the “toxic” substance, belladonna and posed a risk to children.
Belladonna, also known as deadly nightshade, is a plant that has been used in cosmetics and herbal medicine, and is also used as a recreational drug because of the hallucinations it can produce.
FDA�Center�for Drug Evaluation and Research director Janet Woodcock said that belladona adversely affects children. “The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” she said.
The FDA�urged parents to throw away the tablets and seek medical care immediately if children experienced symptoms, including seizures, difficulty breathing or agitation.�”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,” Ms Woodcock said.
The FDA launched an investigation in the US last year after 10 babies died and many others had adverse reactions to the product.�It asked the manufacturer, Standard Homeopathic Company, to recall the products, but the company�refused.
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 issues and said no action would be taken.
In Hyland’s website, there were�numerous�pharmacies that still sell teething products in Australia, including Terry White Chemists�and Priceline.�Fairfax Media also found Hyland’s teething products for sale at Drew Wood Pharmacy at the Royal Children’s Hospital on Thursday.
Australian Skeptics member Peter Hogan, who has been investigating the sale of Hyland’s teething products in Australia, questioned whether more testing was required after the FDA found inconsistent levels of belladonna between batches.
A TGA spokeswoman said samples had been tested from two batches of the tablets and no problems were identified, while one batch of the teething gel was also 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.
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.
Hyland’s Australian distributor, Kadac, has been�contacted for comment.
Source:�Essentialbaby.com.au
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