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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25 Comments

  1. Alan Schmukler
    21/02/2017

    The FDA never said that the remedy caused any side effects. On the other hand, prescription drugs, properly prescribed and taken, are the 4th leading cause of death in the U.S. (according to a study published in Journal of the American Medical Assoc). Where is the indignation about that!!

    • Mark Mattingly
      21/02/2017

      They did say that you could not count on them being safe. Poor quality control at the very least. Prescription drug dangers are real and widely known. The fact that homeopathic drugs can’t be shown convincingly effective for any condition, doesn’t say anything about any conventional acting drug.

      • Alan Schmukler
        21/02/2017

        RE: The fact that homeopathic drugs can’t be shown convincingly effective for any condition..
        That is not a fact, it is Pharma propaganda. I believe that the 224,279 board certified homeopathic physicians who practice in India curing everything from Dengue fever to Leprosy would be surprised to know that they have been using placebos all these years. So would the 42% of British medical doctors who refer their patients to a homeopath, or the 39% of French physicians who prescribe the remedies, and the 20% of German physicians who prescribe homeopathic remedies, or the 40% of Dutch doctors who do the same. The thousands of veterinary homeopaths who cure both pets and farm animals of chronic and acute diseases would also be surprised, as would the farmers who pay for those services.
        Aside from that, here are a portion of the studies affirming homeopathy:
        http://www.homeopathyworks.com/content/Homeopathy%20Research%20Evidence%20Base%207.7.16%20Master.pdf

        • Mark Mattingly
          21/02/2017

          Some would be surprised to know that they are giving out ineffective remedies. There are no homeopathic remedies that have been found effective for Dengue fever or Leprosy.

          • PaolaBrown
            24/02/2017

            So I’m confused—IF homeopathic remedies are ineffective, then how can they also be dangerous (as suggested in this article) at the same time? It seems that logic is not part of the commentary here.

          • Ronky
            24/02/2017

            I don’t understand your reasoning. There are many things which are ineffective and also dangerous.

          • PharmOwner
            24/02/2017

            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.

            Homeopathic remedies SHOULD be safe because they are diluted so much as to have very little effect. However, if the “active” substance(s) are present in larger than stated doses, then they could have a pharmacological effect

          • Mark Mattingly
            25/02/2017

            Poor quality control.

          • BBF
            27/02/2017

            They have no reply, it’s nonsense. Stifle the natural medicines so that pharmaceuticals sell.

        • Ian Carr
          21/02/2017

          Please don’t go down the black hole of conspiracy theories. (“pharma propaganda”.) It is the last resort of those who have no credible arguments.

          • PaolaBrown
            24/02/2017

            Yes because that would require you to think for your self rather than trusting the information that is being fed to you by large corporations. The evidence of homeopathic effectiveness is there, one must just learn how to critically think past information that is spoon fed to them.

        • Laurie J. Willberg
          21/02/2017

          Let’s not forget the monumental impact of Homeopathy for annual Leptospirosis outbreaks in Cuba. The Findlay Institute which is a world-class manufacturer of conventional vaccines produced the Homeopathic product which has virtually eradicated the disease nationwide at 10% of the cost of previously manufactured vaccines.

      • BBF
        27/02/2017

        A hundred years of use points to GRAS. It’s not poor quality control, it’s poor control over the revolving door between government institutions and big pharma.

    • Ian Carr
      21/02/2017

      I think you will find that your “cause of death” statistics are misinterpretations of data by quack campaigners. A red herring with respect to this topic.

  2. Ronky
    21/02/2017

    The TGA is not good enough on ANY homoeopathic product. If they allow homoeopathic junk “medicines” on the market they should at least require that they be formulated and marketed according to the basic principle of homoeopathy, that “like causes like”, i.e. that an infinitesimally diluted drug or poison causes the OPPOSITE effect to what the drug/poison causes in normal doses. So according to homoeopathic theory, one should treat e.g. acid reflux indigestion with homoeopathic hydrochloric acid.
    Instead, the TGA allows these charlatans to directly contradict their own theory in order to con people who don’t know what “homoeopathic” or a discreet little symbol like “10C” or “16X” means, into thinking that their product actually contains an effective dose of a drug (which would be a prescription-only drug if it actually had an effective dose).
    Thus in this case the belladonna is presumably supposed to help teething by drying up secretions of the mouth and Eustachian tube, i.e. the effect of a normal dose of belladonna. Similarly products of homoeopathic melatonin are marketed as sleeping aids, when according to homoeopathic principles they should be used as aids to stay awake.

    • BBF
      27/02/2017

      Every country in the world has homeopathic medicine. Attacks in the US are ridiculous claims, anecdotal reporting but no medical diagnosis or inference.

      • Ronky
        27/02/2017

        What about responding to my point? If you call your product homoeopathic, then at least be honest to your own philosophy and make homoeopathic claims for it, instead of anti-homoeopathic claims.
        Yeah every country in the world has thieves and charlatans. That doesn’t mean they’re a good thing.

  3. Paige
    21/02/2017

    We voluntarily removed these off our shelves months ago. Get this trash out of pharmacy.

  4. Laurie J. Willberg
    21/02/2017

    No evidence of any infant deaths at all. Hylands has not recalled its products because the FDA was unable to produce any test results. Probably because they don’t actually test anything…

  5. AlPhur
    21/02/2017

    “Cum hoc ergo proper hoc” fallacy, together with a concerted campaign to discredit homeopathy by ignoring most of the supporting evidence.

    The anti-homeopathy pseudo-skeptic propagandist liars should know that. It’s called critical thinking.

  6. BBF
    27/02/2017

    That is pure speculation and inference. It was NOT linked to deaths. It was anecdotal, and to ‘link’ them to deaths is poor journalism. Look to vaccines and toxins in those children, not teething tablets. Get your facts straight.

  7. Ian Carr
    27/02/2017

    I am very interested to hear of the continuing research into homeopathic “Berlin Wall”. https://homeopathyonline.org.uk/8-2/berlin-wall/

  8. Science-based Homeopathy has its Mission Statement, Objectives and Widget
    https://drnancymalik.wordpress.com/about/blog

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