MD, PhD, FMedSci, FSB, FRCP, FRCPEd

Homeopathic products are safe!

At least this is what the homeopathy-lobby tries to make us believe. On this blog, we have repeatedly questioned this notion, and recently it was reported by several sources, for instance this website, that the FDA has taken action against one specific homeopathic remedy over safety concerns:

Some homeopathic tablets and gels aimed at helping to soothe babies’ teething pains may be dangerous for infants and toddlers, the FDA announced and stated they are now investigating reports of seizures in infants and children who were given homeopathic teething products: “consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation” after using homeopathic teething tablets and gels. The FDA also said it is not aware of any proven health benefit of using homeopathic teething tablets and gels.

Already in 2010, the FDA had issued a safety alert about a homeopathic teething tablet that contained belladonna. Belladonna, a poisonous plant that contains atropine. At high levels, atropine can be deadly. In homeopathy, it is used to treat redness and inflammation. At the time, the FDA found that the teething tablets contained inconsistent amounts of belladonna. The company that made the tablets, Hyland, subsequently recalled the product.

The full FDA statement is here:

The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.

Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.

Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.

“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”

The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.

Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA’s MedWatch Adverse Event Reporting program:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

END OF QUOTE

What follows is, I think, simple: homeopathic products are not necessarily safe, and there can be several reasons for that:

  • they can be contaminated,
  • they can be adulterated,
  • some can contain high concentrations  of toxic ingredients,
  • most contain nothing active at all and are dangerous when mistaken for an effective therapy.

 

23 Responses to FDA safety alert about homeopathic teething remedies

  • I do not see how the FDA can be “responsible for the safety, etc.of dietary supplements,etc” in the last paragraph, since the US congress tied their hands, eliminating regulation of supplements, vitamins, etc. in 1994 by passing the DSHEA laws sponsored by alleged health experts senators Orin Hatch of Utah and Tom Harkin of Iowa. This has allowed the multi billion dollar alternative supplement and fake health care industries to flourish. These two non medical, illegitimate health care advocates have done more harm to health care than Prince Charles.

  • i found more info here: http://www.bloomberg.com/news/articles/2016-10-12/giving-teething-babies-homeopathic-remedies-could-kill-them
    “More than 400 teething babies given homeopathic remedies to help ease gum pain developed serious health problems over the past six years, including seizures, shortness of breath, vomiting, and constipation, according to an investigation by U.S. regulators. At least 10 died….”

  • 10 children die after taking homeopathic teething pills

    The US Food and Drug Administration (FDA) is investigating the deaths of 10 children and 400 adverse events surrounding the use of homeopathic teething pills.

    The FDA warned that teething children should stop using the treatment, and to go to a doctor if the child exhibits symptoms like seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation – similar symptoms displayed over the last six years.

    The agency also asked caregivers and parents to throw away any remaining pills and gels.

  • @ Alan Henness on Thursday 13 October 2016 at 14:26

    Rezulin (Troglitazone) Use: Antidiabetic and anti-inflammatory Manufacturer: Parke-Davis/Warner Lambert (now Pfizer) Jan. 29, 1997 to Mar. 21, 2000

    Cause for recall:at least 90 liver failures; at least 63 deaths. About 35.000 personal injury claims were filed against the manufacturer (Pfizer).

    Selacryn (Tienilic acid) Use: blood pressure. Manufacturer: SmithKline May 2, 1979 to 1982

    Cause for recall: hepatitis; 36 deaths; at least 500 cases of severe liver and kidney damage

    Vioxx (Rofecoxib) Use: NSAID (pain relief) Manufacturer: Merck May 20, 1999 to Sep. 30, 2004

    Cause for recall: increased risk of heart attack and stroke; linked to about 27,785 heart attacks or sudden cardiac deaths between May 20, 1999 and 2003

    • Anyone know an example of homeopathic remedy recalled because it didn’t work?

    • What’s that got to do with homeopathy?

      • @Alan Henness on Friday 14 October 2016 at 09:42

        “The US Food and Drug Administration (FDA) is investigating the deaths of 10 children and 400 adverse events surrounding the use of homeopathic teething pills.”

        Why was this a surprise? You promote collateral damage as part of medical learning in the scientific medical system.

        From 3 drugs shown above, 27884 deaths and 35500+ adverse events. This is a very small part of the story. This was put in for you to get a reality check in case you suffered from selective amnesia.

        The picture is as of 2004: based on science with physics and chemistry working together, proved through RCT with p values confirming positive statistical evidence.

        What was missed? Pfizer, SmithKline and Merck are the best companies in the scientific medical business.

        • Was it that you failed to comprehend my question?

          What’s that got to do with homeopathy?

          • @Alan Henness on Saturday 15 October 2016 at 12:46

            “What’s that got to do with homeopathy?”

            Practitioner’s ability to kill patients under the Allopathic medical system (supported by physics and chemistry and the largest pharmaceutical companies) is many million times more than those in the homeopathic system.

          • Thanks for confirming it’s got nothing to do with homeopathy, Iqbal.

          • @Alan Henness on Saturday 15 October 2016 at 12:46

            “Thanks for confirming it’s got nothing to do with homeopathy,”

            There is a better explanation: People living in glass castles shouldn’t throw stones.

            But this proverb was for intelligent people.

          • intelligent people might even get the proverb right!

  • Hyalnd have withdrawn the products in question (“It is therefore with much sadness that we share with you that we have chosen to discontinue the distribution of our Hyland’s teething medicines in the United States. This decision was made in light of the recent warning issued by the Food & Drug Administration (FDA) against the use of homeopathic teething tablets and gels. This warning has created confusion among parents and limited access to the medicines.” ):
    “It is therefore with much sadness that we share with you that we have chosen to discontinue the distribution of our Hyland’s teething medicines in the United States. This decision was made in light of the recent warning issued by the Food & Drug Administration (FDA) against the use of homeopathic teething tablets and gels. This warning has created confusion among parents and limited access to the medicines.” 

    • This warning has created confusion among parents and limited access to the medicines.

      Confusion?! The warning seems pretty straightforward to me. It states very plainly that parents shouldn’t use ‘homeopathic’ teething tablets and gels and should discard any such products they may have around the house.

      I wonder if homeopathists would regard a similar warning about a pharmaceutical product to be confusing. Perhaps Hyland mean to imply the confusion is brought about by homeopathists constantly reiterating that their stuff is ‘safe’ when the opposite is sometimes the case.

  • @Edzard on Tuesday 18 October 2016 at 10:45

    “intelligent people might even get the proverb right!”

    It was long back that houses in the allopathic system became castles: feeding off ill humans is very paying.

    ““It is therefore with much sadness that we share with you that we have chosen to discontinue the distribution of our Hyland’s teething medicines in the United States.

    You spent a good part of your life proving to every one that homeopathic remedies have no effect what so ever. A bit of surprise here. Belladona used was in 12X potency!!! The other surprise reference for you was Rhus Tox?

    Hyalnd have followed the safest route: don’t take bad publicity. Not like Merck: they kept on insisting that bodies lining up were not due to Vioxx, until everyone knew about the disaster. And then they also with drew Vioxx.

    There is a couplet in Urdu, that translates roughly as: to destroy a flower garden, one owl is enough. What would be the fate of the flower garden, with each branch in the garden occupied by an owl.

    http://www.msn.com/en-in/health/medical/the-50-most-dangerous-drugs/ss-BBv0zdJ?li=AAggbRN#image=51

  • the ‘National Center for Homeopathy’ has responded (http://www.benzinga.com/pressreleases/16/10/p8574113/national-center-for-homeopathy-responds-to-fdas-warning-against-homeopa) :
    On September 30th, the Food and Drug Administration (FDA) issued a press release entitled “FDA warns against the use of homeopathic teething tablets and gels.” The response that followed led to the removal of homeopathic teething products from the shelves of stores.
    The FDA later clarified in the press release that they were conducting an ongoing investigation as a response to reported serious adverse events. “While the FDA’s warning about homeopathic teething preparation seems arbitrary and capricious,” said Alison Teitelbaum, NCH Executive Director, “The media’s exaggerated fear mongering has made a bad situation worse.”
    Homeopathy has a laudable and extensively documented clinical record and there are hundreds of high quality, peer-reviewed basic science, pre-clinical, and clinical studies showing its efficacy and safety. There are no studies linking homeopathically-prepared medicines and serious adverse events.

    “Despite these facts, groups interested in seeing homeopathy destroyed continue to hammer away at the system – making exaggerated claims that create misunderstandings about and limit consumer access to homeopathic products,” continued Teitelbaum.
    Homeopathy is a safe, gentle, and natural system of healing that works with your body to relieve symptoms, restore itself, and improve your overall health. It has been used successfully for the last 200 years by over 250 million people worldwide. Homeopathy is growing in popularity in the United States, where homeopathic over the counter (OTC) medicines are regulated by the FDA and have been so for decades.

  • in relation to these homeopathic remedies, a US law firm has announced the following:
    There may be compensation available for families whose children were harmed as a result of homeopathic teething remedies. To learn more about filing a teething tablet lawsuit on behalf of your child, please call (888) 870-9331 to obtain a free, no-obligation review of your case.
    http://www.teethingtabletslawsuit.com/

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