MD, PhD, FMedSci, FSB, FRCP, FRCPEd

I am sure this  FDA press-release will interest many readers (we reported about this case before):

The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.

In light of these findings, the FDA contacted Standard Homeopathic Company in Los Angeles, the manufacturer of Hyland’s homeopathic teething products, regarding a recall of its homeopathic teething tablet products labeled as containing belladonna, in order to protect consumers from inconsistent levels of belladonna. At this time, the company has not agreed to conduct a recall. The FDA recommends that consumers stop using these products marketed by Hyland’s immediately and dispose of any in their possession. In November 2016, Raritan Pharmaceuticals (East Brunswick, New Jersey) recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.

“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. ”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.”

Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children. In September 2016, the FDA warned against the use of these products after receiving adverse event reports.

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 products.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething products 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 PRESS RELEASE

Well, this will be irritating to many homeopathy-fans, not least to our friend Dana Ullman. He likes to publish articles alleging that the US authorities have recently taken to being ever so unfair to the homeopathic industry. I commented recently on his paper entitled “Extreme Bias in FTC’s Ruling on Homeopathic Medicine” where he displays the well-known biases and ignorance of his trade in exemplary fashion, including the often firm anti-vaccination stance of homeopaths. Dana can also not resist claiming that ‘the Swiss government’s “Health Technology Assessment” on homeopathic medicine is much more comprehensive than any previous governmental report written on this subject to date’ and – how could it be otherwise? – is sufficient proof that homeopathy works.

In case you believe in what Ullman says, you ought to read the intriguing evidence about Ullman after being called as an expert witness in an US class action. On this occasion, the judge stated:

The Defendant presented the testimony of Gregory Dana Ullman who is a homeopathic practitioner. He outlined the theory of homeopathic treatment and presented his opinion as to the value and effectiveness of homeopathic remedies. The Court found Mr. Ullman’s testimony to be not credible. Mr. Ullman’s bias in favor of homeopathy and against conventional medicine was readily apparent from his testimony. He admitted that he was not an impartial expert but rather is a passionate advocate of homeopathy. He posted on Twitter that he views conventional medicine as witchcraft. He opined that conventional medical science cannot be trusted.
[…]
Mr. Ullman’s testimony was unhelpful in understanding the purported efficacy of the ingredients of SnoreStop to reduce the symptoms of snoring. Although he is familiar with the theory of homeopathic treatment, his opinions regarding its effectiveness was unsupported and biased. The Court gave no weight to his testimony.(Rosendez v. Green Pharmaceuticals)

Say no more!

34 Responses to FDA: homeopathic teething remedies were toxic

  • Thanks for the report Dr. Ernst.

  • The FDA alert is based on reports by parents, not science or proven by autopsy. Do you really think the 0.0000000000003% homeopathic belladonna content in a single tablet is unsafe and was responsible for any deaths or serious adverse effects?

    I am sure you are aware that the belladonna content in a single Donnatal tablet is 16.2 mg. Other FDA approved prescription drugs contain similar higher amounts of atrope belladonna. Additionally, ophthalmic drops used to dilate the pupil to better view the back of the eye, contain a higher level of belladonna and have not adversely affected any patients.

    Based on your stance on the ineffective use of any homeopathic preparations and in my opinion, it would be honorable of you to inform the FDA that the belladonna content is truly not the cause of the parents reported adverse events and encourage them to do further research. Would you even consider telling them? I would like to believe you would.

    • ” Do you really think the 0.0000000000003% homeopathic belladonna content in a single tablet is unsafe and was responsible for any deaths or serious adverse effects?”
      no, apparently the quality control of the manufacturer was so sloppy that the products contained toxic amounts of belladonna.
      The FDA did analyse the samples and they employ experts who do not need my wisdom.

    • Sandra said:

      The FDA alert is based on reports by parents, not science or proven by autopsy. Do you really think the 0.0000000000003% homeopathic belladonna content in a single tablet is unsafe and was responsible for any deaths or serious adverse effects?

      You’re wrong again, of course, Sandra. The FDA said that its:

      laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label.

      Just how much they don’t yet say, but it seems they want to protect children from unnecessary risk.

      I am sure you are aware that the belladonna content in a single Donnatal tablet is 16.2 mg.

      You’re wrong again, of course, Sandra. Drugs.com lists the active ingredients of one Donnatal tablet as:

      Phenobarbital, USP 16.2 mg
      Hyoscyamine Sulfate, USP 0.1037 mg
      Atropine Sulfate, USP 0.0194 mg
      Scopolamine Hydrobromide, USP 0.0065 mg

      The Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide are are the Belladonna ingredients and together they amount to 0.1296 mg, not 16.2 mg as you claimed, which is the Phenobarbital content. Anyway, since we don’t know what levels of Belladonna the FDA found – and because you wouldn’t give Donnatal to infants for teething problems, your point is also irrelevant. As is your point about it being used to dilate pupils.

      Based on your stance on the ineffective use of any homeopathic preparations and in my opinion, it would be honorable of you to inform the FDA that the belladonna content is truly not the cause of the parents reported adverse events and encourage them to do further research.

      You have failed to understand the whole point, Sandra, but since the FDA have not said what Belledonna content they measured, it would seem somewhat rash to jump to the conclusion that – as you seem to believe – it could not possibly be the Belladonna that was to blame. Unless you know something the FDA doesn’t?

      But perhaps you’re not at all concerned about placing infants at unnecessary risk of poisoning or death? It would seem that Standard Homeopathic Company (Hylands) is equally unconcerned.

    • Interesting that elsewhere, Sandra regards subjective reporting by patients and parents as the cast-iron proof of the efficacy of her favoured nostrums. Self-reported improvement in symptoms is fraught with bias. Self-reporting of infant death somewhat less so.

      Anyway. Carry on, Sandra. Your hapless rhetorical flailings are an ongoing source of amusement.

  • I have yet to find a single documented case of autopsy proven morbidity in the scientific literature that was directly attributed to the ingredients in Hyland’s teething tablets. If you have, I would like to read it.

    So far, the only report in the literature I have found about deadly nightshade (from France) concerns a 2 y.o. boy who ingested some of the berries from an actual nightshade plant. He was monitored in an intensive care unit for 48 hours, treated symptomatically (probably via homeopathy), then released without adverse permanent sequelae. https://www.ncbi.nlm.nih.gov/pubmed/21194906

    This statement by you implies that you believe homeopathy has an effect. “But perhaps you’re not at all concerned about placing infants at unnecessary risk of poisoning or death? It would seem that Standard Homeopathic Company (Hylands) is equally unconcerned.”

    • @Sandra

      We can move on to talk about other things if you like but it’s interesting that you’ve not responded to the points I corrected you on.

      Anyway, Sandra said:

      I have yet to find a single documented case of autopsy proven morbidity in the scientific literature that was directly attributed to the ingredients in Hyland’s teething tablets. If you have, I would like to read it.

      Please do let us know of you find any. Of course, no one here has claimed that they exist, but nice try as a diversion. A fail on your part.

      So far, the only report in the literature I have found about deadly nightshade (from France) concerns a 2 y.o. boy who ingested some of the berries from an actual nightshade plant. He was monitored in an intensive care unit for 48 hours, treated symptomatically (probably via homeopathy), then released without adverse permanent sequelae. https://www.ncbi.nlm.nih.gov/pubmed/21194906

      Again, not sure why you were looking for that, but in your searching, did you happen across any good evidence that homeopathic belladonna was effective for teething?

      This statement by you implies that you believe homeopathy has an effect. “But perhaps you’re not at all concerned about placing infants at unnecessary risk of poisoning or death? It would seem that Standard Homeopathic Company (Hylands) is equally unconcerned.”

      I really can’t help you much when you fail to comprehend such a simple statement. I’d suggest you try opening your mind up to alternative possibilities… such as that raised by the FDA and which I highlighted in my last comment to you.

      • There is no scientific evidence of seizures, death or permanent adverse effects as a direct result of the minute amount of belladonna alkaloids in teething tablets. If there is, Ernst will probably post a link.

        • oh dear, the FDA measured the content, issued a warning and you say “There is no scientific evidence of seizures, death or permanent adverse effects as a direct result of the minute amount of belladonna alkaloids in teething tablets…” Somehow I trust the FDA more than you!

          • My apologies for making you look like the hypocrite you are. I find it laughable that you, a staunch opponent of homeopathy, would now maintain that the small amount of belladonna in teething tablets is actually effective. To me, this would indicate that you cannot be counted on to be consistent in your theories. Does homeopathy work in teething tablets, but otherwise not?

            I would like to see the evidence I asked for earlier. With regard to the FDA’s warnings about the teething tablets: Where is the definitive cause/effect scientifically proven evidence? Autopsies? Toxicology studies? ER visit reports?

          • surely you cannot be that thick: as I told you earlier – sloppy quality control meant that there were toxic concentrations in the teething remedies [according to the FDA statement]

          • Sandra said:

            My apologies for making you look like the hypocrite you are. I find it laughable that you, a staunch opponent of homeopathy, would now maintain that the small amount of belladonna in teething tablets is actually effective. To me, this would indicate that you cannot be counted on to be consistent in your theories. Does homeopathy work in teething tablets, but otherwise not?

            I would like to see the evidence I asked for earlier. With regard to the FDA’s warnings about the teething tablets: Where is the definitive cause/effect scientifically proven evidence? Autopsies? Toxicology studies? ER visit reports?

            It may be difficult for occasional readers here to decide whether your obtuseness and stupidity is a deliberate ploy to demonstrate some obscure point or other. Others, however, will be left in no doubt.

          • One can smile tentatively when homeopaths poison themselves and hope they survived to learn something from their bungling stupidity.
            But when these idiots SELL poisonous pills for gullible mothers to give to their babies, and that in lorryloads in supermarkets and pharmacies, then they should be locked up!

          • @Edzard to @Sandra: “surely you cannot be that thick”

            Well… Actually, she can be. It’s a horrifying thought, I know, but she really is that thick.

        • Sandra said:

          There is no scientific evidence of seizures, death or permanent adverse effects as a direct result of the minute amount of belladonna alkaloids in teething tablets. If there is, Ernst will probably post a link.

          Have you deliberately ignored the point about the FDA and quantity or have you simply failed to understand it again?

  • I trust the wise advice of President Reagan who once said: “Trust, but verify.”

    I keep asking where’s the proof. Not seen it yet. Is homeopathy a placebo effect or not? It causes systemic changes in some cases, but not in others?

    Smile for the truth camera. It was so easy. I’ve exposed your skepticism for what it is. Biased bunk.

    • Sandra said:

      I trust the wise advice of President Reagan who once said: “Trust, but verify.”

      I keep asking where’s the proof. Not seen it yet. Is homeopathy a placebo effect or not? It causes systemic changes in some cases, but not in others?

      Smile for the truth camera. It was so easy. I’ve exposed your skepticism for what it is. Biased bunk.

      Now that truly is hilarious!

      Let me try to help you just one last time and save Prof Ernst the trouble. You seem to be fixated on the notion that the Belladonna homeopathic products had the quantity of Belladonna as stated on the label. Now, that maxim of Reagan’s you are so willing to expound… Do you trust Hylands, etc that the quantity is as stated on the label? Perhaps you don’t think a homeopathy manufacturer would ever make a mistake? Perhaps you think the FDA had no business checking that levels of that deadly toxin were safe? Such blind faith in the manufacturers would indeed be touching, but fortunately, the FDA seem to have been more interested in protecting the public than merely accepting the word of the manufacturer. They verified.

      Now we come the bit where – although it’s been pointed out to you (and quoted to you) on several occasions – the FDA state they did verify and, lo and behold, they did find levels of Belladonna “sometimes far exceeding the amount claimed on the label”. That last bit is a direct quote from the FDA but one you seem determined to ignore.

      Now, we can either trust that you know more about the manufacturing and quality controls of the manufacturers such that you can categorically state that the probability of those products containing amounts of Belladonna far exceeding the amount claimed on the label is precisely zero, or we can put a greater reliance on the FDA. Who would an unbiased observer trust do you think?

    • I trust the wise advice of President Reagan who once said: “Trust, but verify.”

      But… you fail to do both of these things.

      You don’t trust experts in the appropriate fields and you actively hunt out data that supports your reality challenged world view while ignoring the mountains of evidence that disagree with you.

      I keep asking where’s the proof. Not seen it yet.

      That would be due to the blinkers you have on.

      Is homeopathy a placebo effect or not?

      Yes, it’s a placebo.

      Smile for the truth camera. It was so easy. I’ve exposed your skepticism for what it is. Biased bunk.

      I have no doubt that you see it that way. But… Yeah… nah.

  • Typical of the low class anti homeopathy activists to attack the messenger when they don’t like the message. I’ve made my point. It was easier than I had thought. Thanks.

    • no, you have no valid point!

    • Sandra said:

      Typical of the low class anti homeopathy activists to attack the messenger when they don’t like the message. I’ve made my point. It was easier than I had thought. Thanks.

      The point was that the point you tried to make blatantly ignored facts that were clearly presented to you. This was pointed out to you on numerous occasions, but the fact you have been unable to grasp it speaks volumes of your inability to think, critically or otherwise.

    • Typical of the low class…

      This coming from the person that took glee in the thought of others dying off first.

      If you weren’t such a horrible person we’d likely have sympathy for you.

    • @Sandra on Monday 06 February 2017 at 14:31

      You were a medical typist for 27 years and, suddenly, you know more than doctors and specialists who studied and interned for 10 or more years?

      You would be hilarious, if you weren’t such a rabidly, dangerous loon.

  • You guys DO realize who Sandra is? I don’t know if she’s as well known in the UK as in North America, but she must tweet 200 times a day hyping her magic sugar water and she keeps a “hitlist” of enemies of homeopathy. If any newspaper anywhere in North America prints an accurate (i.e. anti-homeopathy) article, she bombards the comments with her standard cut-and paste anecdotes and “talking points.” (she loves using that term to ignore scientific arguments).

    She’s also rabidly anti-vaccination, thinks all “allopathic” doctors are either incompetent or are killers and believes cancer can be treated by homeopathy in India. (those lying Banerjee quacks.)

    While I admire your efforts and your endless patience, you’re all wasting your time with her, but it’s been very amusing to read.

    • I think we do know her… and corresponded for the fun of it. she also posted a comment on my new book (HOMEOPATHY, THE UNDILUTED FACTS) on Amazon USA – clearly without having read it:
      “BySandra A Hermann-Courtneyon December 12, 2016
      Edzard Ernst is a well known UK anti homeopathy activist. That being said, this book will be enjoyed by homeopathy skeptics, not by people who have been helped by this form of treatment. Many more books about homeopathy, written by experienced practicing (some for decades) homeopaths, are available on Amazon.”
      SHE IS PRICELESS!!!

    • Oh yes, we all know who she is and are very familiar with her tactics and substantial shortcomings in understanding argumentation, science and evidence.

  • Here’s an example of Sandra-logic:

    The Department of Transport discovers that airbags installed in a certain model of car are defective, won’t deploy in an accident and orders a recall.

    Deluded airbag company executive: “We’re getting a bum rap here from the government! Show me some autopsies proving our airbags caused a death!!”

  • Ha! Had missed that Prof Ernst had already posted this link, but my quotes from it are till useful: Amid Reports of Infant Deaths, FTC Cracks Down on Homeopathy While FDA Investigates

    On September 30, the FDA issued a warning to consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The agency recommended that consumers stop using the products.

    The same day as the warning, CVS Pharmacy voluntarily removed all brands of homeopathic teething products from its online and retail stores. This included its store brand product, which was cited in the adverse event report that triggered the FDA investigation. Less than 2 weeks later, Hyland’s, a popular purveyor of homeopathic teething remedies, discontinued its line in the United States. The action prevented new Hyland’s teething products from entering the market but did not address products already on store shelves.

    In late November, Raritan Pharmaceuticals issued a voluntary recall of 3 homeopathic teething and ear relief products for infants and children—including the CVS tablets—after the FDA investigation found varying levels of belladonna in the products and recommended the recall.

    “The FDA is concerned about inconsistent amounts of belladonna, a potentially toxic ingredient if present in sufficient quantities, in homeopathic products,” FDA press officer Lyndsay Meyer said in an email after the recall was announced.

    Then, in January of this year, the FDA announced that its laboratory analysis had found elevated belladonna levels in certain homeopathic teething tablets that “far exceeded” the amount stated on the label.

    Although the announcement did not specify the brand of tablets with high levels of belladonna, it stated that the agency had asked Standard Homeopathic Company, the makers of Hyland’s homeopathic teething remedies, to recall its teething pills, which would remove them from stores and online retailers.

    At press time, the company had not agreed to the request, according to the FDA. The agency does not have authority to force the recall, and it would not comment on possible compliance and enforcement actions.

    “I think there are some really substantial safety concerns, as illustrated by this warning from the FDA,” said Josephine P. Briggs, MD, director of the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH). “We are concerned about the regulatory issues and concerned about public safety.”

  • more details were reported recently here (https://www.managedcaremag.com/dailynews/20170413/quackery-alert-fda-accused-acting-too-timidly-outlaw-harmful-homeopathic-cures):
    According to the FDA investigation (the results of which STAT obtained under the Freedom of Information Act) the tablets, as well as the jell form, allegedly caused 370 babies to suffer seizures and stop breathing between 2006 and 2016.
    STAT: “Babies who were given Hyland’s teething products turned blue and died. Babies had repeated seizures. Babies became delirious. Babies were airlifted to the hospital, where emergency room staff tried to figure out what had caused their legs and arms to start twitching.”

  • MORE TROUBLE FOR HYLAND’S (https://topclassactions.com/lawsuit-settlements/lawsuit-news/601091-hylands-homeopathic-products-class-action-settlement/#comments):
    Hylands Inc. has agreed to settle a class action lawsuit over allegations it made false and misleading statements about the effectiveness of certain homeopathic products for children.
    If you purchased certain Hyland’s homeopathic products for babies or children between March 8, 2008 and March 30, 2017, you may be entitled to a refund from the Hyland’s class action settlement.
    The Hyland’s products named in the homeopathic products settlement include:
    Cold ‘n Cough 4 Kids
    Cough Syrup with 100% Natural Honey
    Sniffles ‘n Sneezes 4 Kids
    Cold Relief Strips 4 Kids with Zinc
    Nighttime Cold ‘n Cough 4 Kids
    Complete Flu Care 4 Kids
    Baby Teething Gel
    Baby Cough Syrup
    Baby Gas Drops
    Baby Infant Earache Drops
    Baby Nighttime Tiny Cold Syrup
    Plaintiffs Enzo Forcellati and Lisa Roemmich filed the Hyland’s class action lawsuit which alleges Hyland’s made false and misleading representations about the effectiveness of the products listed above, in violation of state and federal law.
    According to the homeopathic products class action lawsuit, Hyland’s falsely represents that its homeopathic products “provide fast, safe and effective relief from cold and flu symptoms.” The plaintiffs argue that homeopathy is pseudoscience, and that Hyland’s homeopathic products contain highly diluted concentrations of the ingredients listed as active ingredients.
    Hyland’s denies any wrongdoing but has agreed to settle the homeopathic products class action lawsuit to avoid the expense and uncertainty of ongoing litigation.

Leave a Reply

Your email address will not be published. Required fields are marked *

Please answer the following: *

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories