Homeopathic teething products draw FDA scrutiny, warning

Photo: Glenn via Flickr

Photo: Glenn via Flickr

The U.S. Food and Drug Administration has launched an investigation to determine whether homeopathic teething products may have played a role in the deaths of 10 children over the past six years.

The agency is also reviewing reports of more than 400 adverse health events among children using the products, including a Sept. 9 case in which a child experienced a seizure. Parents and caregivers have been urged to stop using the products and have been told to seek immediate medical attention for children who experience seizures, breathing problems, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficult urination or agitation after using homeopathic teething tablets and gels.

“At this time, the FDA is still conducting our investigation, and we have not yet completed the analyses of products to determine if there is an association between the adverse events and the homeopathic teething products,” noted FDA press officer Lyndsay Meyer in an Oct. 14 email.

Meyer stressed that adverse event reports do not by themselves provide conclusive evidence of problems with products. A preliminary review has indicated that reports of recent adverse events are similar to those observed in 2010 when the FDA warned consumers against using a popular brand of homeopathic teething remedies, Hyland’s Teething Tablets.

Testing by the FDA at that time determined that the tablets contained inconsistent amounts of the plant ingredient belladonna. Also known as deadly nightshade, the plant has been used for centuries as both a poison and a medicine.

“Hyland’s Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled,” the FDA noted in 2010.

In a Sept. 30 statement alerting consumers to new concerns about homeopathic teething remedies, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, urged parents to find other ways to soothe children suffering teething pains.

“Teething can be managed without prescription or over-the-counter remedies,” said Woodcock. “We recommend parents and caregivers do not give homeopathic teething tablets and gels to children and seek advice from their health care professionals for safe alternatives.”

Jen Christensen has been following the warnings for CNN. In an Oct. 13 story, she and colleague Jamie Gumbrecht reported that Hyland’s would stop distributing the products in the United States. In an Oct. 5 piece, alerting parents to the potential dangers, Christensen noted that a large chain has stopped selling a range of homeopathic teething remedies.

“CVS, one of the drug store chains that sells Hyland’s, Baby Orajel Naturals and its own version of the product, has pulled them from the shelves,” she reported.

Earlier this year, CNN’s Nadia Kounang looked at teething pain from another angle in a story, “No, Your Baby’s Fever Was Not Caused by Teething.”

The piece took off from a major analysis of the signs and symptoms of tooth eruption, published in February in Pediatrics. While teething can make babies uncomfortable, it won’t usually make them sick, concluded the authors of the study, who looked at teething research from eight countries.

Gum irritation, irritability and drooling are the most common symptoms of teething they found.

While a slight rise in body temperature is also common, a true fever (higher than 100.4) could indicate the presence of illness or infection requiring medical treatment, they noted. For normal teething pain, the simplest of interventions are the best experts say.

“Just comfort your child and get through it,” Dr. Paul Casamassimo, director of the American Academy of Pediatric Dentistry’s Pediatric Oral Health and Research and Policy Center told Kounang in her report for CNN.

A cold rag or teething toy could help with the discomfort, Casamassimo said.

“Infant pain relievers might also be an option, but Casamassimo urged parents to be careful. Regular use can lead to tooth decay, and acetaminophen is a leading cause of liver disease in children,” Kounang reported.

“’If you have to keep doing it day after day,’ it may be a concern,” Casamassimo said.

2 thoughts on “Homeopathic teething products draw FDA scrutiny, warning

  1. Avatar photoTerry Griffin

    This is nuts. Homeopathy, by its own definition, is based on the principle that any substance presumed to be active is diluted to the point of inactivity. Further, what is belladonna of any concentration doing in any teething biscuits?

  2. Avatar photoKenneth Stoller

    The FDA, in their wisdom and duty to protect us from dangerous foods, devices and drugs, has issued a warning against Hyland’s Teething tablets because they contain Belladona (0.00000000000000003% to be exact).

    Not plutonium, not mercury, not cyanide but Belladonna.
    What is Belladonna that the FDA felt it needed to issue a warning to parents?

    Belladonna has long been an herbal pain reliever, muscle relaxer, and anti-inflammatory.

    The Solanaceae is a family of flowering plants known as the nightshade or potato family are both edible and poisonous. The family includes the Datura or Jimson weed, eggplant, mandrake, deadly nightshade or belladonna, capsicum (paprika, chile pepper), potato, tobacco, tomato, and petunia.

    The Solanaceae are known for possessing a diverse range of alkaloidal glucosides, (alkaloids), such as tropanes (atropine) and hyoscine (scopolamine), as well as nicotine and solanine. These toxins have anticholinergic properties so at high levels will produce symptoms such as dilated pupils, tachycardia, loss of balance, headaches, flushing, dry mouth, urinary retention, delirium and convulsions. Nicotine is an alkaloid as is caffeine and cocaine.

    Belladonna, for the most part, is a combination of these alkaloids: Atropine, Hyoscyamine, and Hyoscine.

    A homeopath would tell you a “Belladonna” patient, that is a patient who might benefit from homeopathic Belladona, would be “dry as bone, red as beet and mad as a hatter.” Because in homeopathy you treat symptoms with a ultra micro dose of the very thing that would cause those symptoms if taken in a concentrated form. In homeopathy it is called the law of similars.

    The Hyland’s Teething tabs contain Belladonna 12x – or one part Belladonna to 10 to the 12th power sugar, since the tablets are made with lactose, so that is what the Belladonna is being diluted into.

    Whether or not one believes homeopathy has any therapeutic benefit, I am not aware that 1 ppt of Belladonna has any deleterious effect. In fact I will go so far as to say it has no effect at all if you just straight dilute it to 1 ppt.

    To put this in context…

    Mercury free (reduced) vaccines contains 2000 ppb of mercury – the most deadly non-radioactive element on the periodic table. The flu vaccines contain 50,000 ppb of mercury.

    1 ppm = 1,000,000 ppt

    So, the flu vaccine has 50 million times more mercury than Hyland’s Teething tablets has Belladonna.

    In my book, Incurable Me (published last month), I discuss the use of mercury in dental fillings. I also included, in the chapter on mercury, my resignation letter to the American Academy of Pediatrics for supporting the continued use of mercury in childhood vaccines. Here is a excerpt from my resignation letter.

    “Vaccines with “trace” amounts of Thimerosal, by definition, “contain less than 1 microgram of mercury (Hg) per dose.” For example, consider that the reduced-Thimerosal flu vaccine with 0.0002% mercury is equivalent to 1 microgram (µg) of Hg per 0.5 mL, or 2 µg of Hg per mL, which is the same as 2000 µg per liter; or 2000 ppb or parts per billion.0.5 parts per billion (ppb) mercury has been shown to kill human neuroblastoma cells. 2 ppb mercury is the U.S. EPA limit for drinking water. 20 ppb mercury destroys neurite membrane structures. 200 ppb mercury is the level in liquid that the EPA classifies as hazardous waste. 25,000 ppb mercury is the concentration of mercury in multi-dose, hepatitis B vaccine vials, administered at birth from 1991–2001 in the U.S. 50,000 ppb mercury is the concentration of mercury in multi-dose DTP and haemophilus B vaccine vials, administered 8 times in the 1990’s to children at 2, 4, 6, 12, and 18 months of age and currently “preservative” level mercury in multi-dose flu, meningococcal, and tetanus (7 and older) vaccines. “

    So, the FDA is concerned about 1 ppt of Belladonna but approves vaccines as safe that have known toxic levels of mercury and aluminum?

    What else is Belladonna in that the FDA should warn us about?

    The Belladonna alkaloids (excluding solanine, etc.) in potatoes come in around 0.02mg/kg (sometimes a little more sometimes a little less and it depends if you are eating the skin, which are usually much higher in these alkaloids.)

    Well, 0.02 mg/kg of Belladonna in potatoes is the same as saying 20 ppm. Let’s say a nice Russet is about 300 grams, one would be getting the equivalent of 7 ppm of Belladonna… Large fries at your favorite fast food place about 150 grams or 3.5 ppm. Now most teething infants will not eat a serving of large fries, but they might be served up mashed potatoes by their mommy. Is the FDA putting out a warning about not feeding potatoes to infants and everyone else for that matter?

    No they do not and why don’t they? Because it is an innocuous amount of Belladonna. It is not lead, plutonium or mercury where there is no safe amount.

    So, why is the FDA picking on Hyland’s teething tablets?

    Because it is homeopathic, it is alternative, and because they can put out a warning and damage sales of something harmless and often effective sold outside of the Big Pharma paradigm.

    I don’t know anyone at Standard Homeopathic anymore – it was almost 40 years ago when I visited their plant and learned how those teething tablets were made, and saw the machines they were made in. I attempted to contact Standard Homeopathic to find out why they rolled over and just pulled the product from the United States market instead of stating what I just stated above as a response….

    They didn’t have to pull the product, but I guess they didn’t want to be seen as a company selling a product that the FDA felt inclined to warn us all about… It would be bad PR and even if they tried to explain this to the public…. do you think the public is going to understand parts per trillion vs parts per billion. The public hears the word poison and that is the end of it. No one buys poison to consume unless you don’t have a choice – like our fluoridated drinking water (fluoride being more toxic than lead).

    If the FDA were being consistent with their concern for us, they would put out warnings for all the mercury laden vaccines – all of them even the ones with only trace amounts (remember – that is still 2000 ppb), but vaccines also contain aluminum, retrovirus and homologous human DNA contaminants. They would be putting out warnings on their website for all vaccines if they were being consistent with their concern about protecting us. Where is the warning for aspartame, which the FDA should never have approved? Where is the warning for Mercury laden dental filings, etc.

    Where are those warnings?

    Something is rotten in Denmark and it isn’t the 1 ppt of Belladonna in Hyland’s Teething tablets.

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