TGA not good enough on homeopathic teething products

A range of homeopathic teething products is still available in Australian pharmacies despite being linked to the deaths of 10 infants in the US

The fact that the products, which contain belladonna, are still available in Australia raises “serious questions” for the TGA, says Friends of Science in Medicine’s Ken Harvey.

He says stocking homeopathic products is a “dereliction of duty” for pharmacists.

Last month, the US Food and Drug Administration announced that its laboratory analysis found inconsistent amounts of belladonna in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label.

In this light of these findings the FDA contacted Standard Homeopathic Company, the manufacturer of Hyland’s Baby teething range, regarding a recall of its homeopathic teething tablet products labelled as containing belladonna. The aim was to protect consumers from inconsistent levels of belladonna.

The FDA recommended consumers stop using these products marketed by Hyland’s immediately, and dispose of any in their possession.

Since a 2010 FDA safety alert regarding the Hyland’s Teething Tablets, the agency has received more than 400 reports of adverse events linked to teething products which contain belladonna.

“Most describe serious adverse events, like seizures,” Lyndsay Meyer, a spokeswoman for the FDA, told CNN.

“We are also aware of reports of 10 deaths during that time period that reference homeopathic teething products.”

It had not yet been determined whether the deaths were directly related to teething products, she said.

Last week, Fairfax media investigated a range of pharmacies, including Terry White Chemists, Priceline and the Drew Wood Pharmacy at Melbourne’s Royal Children’s Hospital, and found the Hyland’s Teething range is still available.

And the RACGP’s Dr Bastien Seidel told Nine News that, “Teething gels actually don’t work, and even worse, they can do significant harm to your baby because they can be toxic.”

Dr Harvey told the AJP today that one would expect a homeopathic product “not to have anything in it, at least nothing to cause any side-effects, but clearly this is a problem”.

The TGA investigated the range after the FDA warning, but found no issues and took no action.

Dr Harvey says this is not good enough.

“How many did the TGA test?” he asked. “Did they look at batch numbers and find out whether those batches were available in Australia? They probably don’t know. Did they liaise with their FDA counterparts at all?

“Or did they just take a few packs off the shelf here and say, ‘There’s nothing wrong’?

“This raises some serious questions for the TGA.”

He also says he strongly approves of a new enforcement policy statement announced by the US Federal Trade Commission last year, which means marketing claims regarding homeopathic drugs will now be held to the standard as other products making similar claims.

This means that measures taken to avoid claims being misleading could include labels which state that homeopathy doesn’t work.

The FTC “recognizes that an OTC homeopathic drug claim that is not substantiated by competent and reliable scientific evidence might not be deceptive if the advertisement or label where it appears effectively communicates that: 1) there is no scientific evidence that the product works; and 2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts,” it said at the time.

“Ever since the NHMRC report on homeopathy came out, some of us have been asking for something like that,” Dr Harvey says.

“If it’s good enough for the US Federal Trade Commission, surely it’s good enough for the TGA?”

He cited comments made by Professor Stephen King, chair of the Pharmacy Remuneration and Regulation Review, on last Monday’s episode of Four Corners, an investigation into the complementary medicines industry.

“He said it very well,” Dr Harvey says. “He said that the danger is that if you start recommending this to mothers, when they get a naturopath saying they need homeopathic immunisation, they’ll go along with it, because you guys [pharmacists] have given it credence.”

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