INTRODUCTION: Homeopathy skeptics maintain that homeopathic remedies are just "sugar pills". For example, this abstract of a published research study concluded that a much higher homeopathic potency of belladonna (30C potency) had only a "placebo" effect. To the skeptics' surprise, however, the FDA has warned consumers that inconsistent amounts of a single ingredient (belladonna) in homeopathic baby teething tablets has caused harm and may be responsible (in nannogram amounts) for infant deaths. But, there is this report in the medical literature of a 2 y.o. boy who ate a handful of deadly nightshade berries (full strength Atropa belladonna) and survived without any permanent sequelae. I cannot understand the argument that homeopathically prepared belladonna can be toxic. Who should parents of teething babies trust? I have added my voice to the debate. All comments are welcome.
Without providing scientific evidence concerning the possible connection between the "inconsistent amounts of belladonna" in Hyland's teething tablets and serious adverse effects to either Hyland's or Standard Homeopathic, the FDA warned parents that Hyland's Teething Tablets are not safe, parents should stop using them and dispose of any tablets in their possession. They went on to state that the "inconsistency in levels of belladonna, a toxic substance, signals a poorly controlled manufacturing process and poses an unnecessary risk to infants and children under two years of age." They added: "The FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity." All of the FDA warnings to parents (2010, 2016 & 2017) have been similar: "Hyland's Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses."
DISCUSSION: These FDA charts represent the results of their analyses of the belladonna content in teething tablet samples. It is important to note that the devices measure nanograms (ng), not milligrams (mg). There are 1,000,000 (one million) nanograms in 1 milligram.
According to Table 4 from the FDA's content analysis charts showing the belladonna content in Sample Number 969639, the number of nanograms in 66 tablets was between 0.1 - 7.2. Inconsistent? Yes. Dangerous? Impossible. Using this free online conversion chart (nanograms to milligrams) and entering the highest level of 7.2 nanograms in 66 tablets, the equivalent result in milligrams was 0.0000072 % of one milligram.
The amount of belladonna in a single teething tablet listed on each box of Hyland's teething tablets is 0.0000000000003% less than 1 mg In comparison, each FDA approved 30 mg B&O suppository contains 16.2 mg of belladonna. Many other FDA approved drugs, such as Donnatal, also contain much higher levels of belladonna alkaloids Additionally, ophthalmologists and retinal specialists use eye drops that contain belladonna to dilate the pupil to enable them to better view the back of the eye. Eight years ago, on a Yahoo Answers page, someone asked how many milligrams were in a 30C amount in a homeopathic remedy. The answer: "30C = a decimal point with 60 zeros after it. That is the dilution. Not one molecule of active ingredient in any of of those little sugar pills. In fact, 30C is equal to one molecule in a container 30,000,000,000 times the size of the earth."
DIFFERENTIAL DIAGNOSES: Babies are teething during the months they are receiving vaccines. The CDC recommended accelerated immunization schedule birth to 15 months is HERE. Are the reported adverse events by parents in some way connected to vaccines as well? Adverse effects to any medication do not occur in a vacuum. And, as a professional involved in all branches of medicine for many years, I would like to pose and have answers to these questions:
1. Were any members of Hyland's medical staff able to review all of the parents' complaints to the FDA? If not, why not?
2. Have the complaints included proper documentation including the birth parents' medical records to include established prior and current diagnoses, prescription drug and/or recreational drug use; was the mothers' prenatal care without complications; what was the child's date of birth; was the child carried to term or were there any detected pre-birth complications; were the attending physician's delivery notes included; was the child delivered by C-section; were all of the transcribed office notes from each of the child's in office examinations as well as current diagnoses and possible prescription drug treatments included; were the dates and types of the child's immunizations for a period of no less than 18 months provided?
3. When did the child first experience symptoms that the reporting parent felt were due to the Hyland's product? Was there a single episode or several? Was the child examined by emergency personnel, the child's pediatrician or internist during or shortly after the reported event?
4. In the 24 - 48 hours leading up to the reported adverse reaction, was the child exposed to any commonly known environmental allergens including cigarette smoke, paint fumes, scented room fresheners, in home use of aerosol insect sprays, a change in laundry detergents or fabric softeners? Additionally, was the child exposed to a new pet (dog, cat, bird, rabbit, etc) in the home?
5. In the 24 - 48 hours prior to the reported adverse reaction, did the child have a change in diet or formula?
6. Should the CDC revise their accelerated vaccine schedule?
HISTORY OF SAFE USE: In September 2016, Health Canada (Canada's drug safety and regulatory agency) shot down the U.S. FTC & FDA by specifically noting that their agency had NOT had any reported serious adverse effects or deaths as a result of homeopathic baby teething tablets. It is important to also note here that no other worldwide country's drug safety regulatory agency has documented or reported similar concerns with regard to the level of belladonna in baby teething tablets.
In defense of their teething tablets (safely used since the early 1900's) Hyland's issued a statement affirming their confidence in the safety of its products: "We are Still Awaiting Data Behind FDA Warning."
A Mom of five blogged her response to this warning: Why I am Not Trowing out my Hyland's homeopathic teething tablets.
A 20+ year user of homeopathy defends the safety of teething tablets:
"Hyland’s teething products have been used in the US for 70 years with complete safety. The FDA approved homeopathics for OTC sales in 1938 based on their overwhelming safety record in clinical use in hundreds of millions of people around the world for more than 200 years.
The FDA may have experts qualified to test the components of conventional drugs but have little knowledge of homeopathy which is an energy medicine. I would have to see a qualified, independent analysis of the products in question before giving any consideration to the FDA’s claim. That analysis would have to be carried out by experts with knowledge of homeopathy using the proper equipment (Raman laser spectroscopy, nuclear spectroscopy, Fourier Transform InfraRed Spectroscopy)
A child would have to ingest a dozen bottles of tablets in order to develop the most minor symptom of belladonna toxicity which is a dry mouth. It is exceedingly difficult to believe that there was any manufacturing error which resulted in toxic levels of belladonna in the final product since homeopathics are nano-medicines . It is not credible to claim that higher amounts of belladonna than listed on the label is evidence that the product caused the incidents in question since they contain less than one molecule of belladonna. It is not credible to assume that because a parent gave a child a teething product the child became ill or died as a result. Making that claim would require independent analysis of the tablets or gel that was actually used. Basing decisions on parents’ statements is not acceptable since the vast majority of parents don’t have the medical knowledge to know what really did cause their child’s illness. Simply claiming that the symptoms are similar to the symptoms of belladonna toxicity is not adequate to determine what did cause those symptoms. It is also not responsible for a doctor to claim the product was at fault simply because a parent told him/her it was given to their child."
CONCLUSION; What the FDA did, without any published science to back their warning, was provide powerful ammunition for the anti homeopathy political activists. The increase in reports of growing demand for natural solutions has most likely been making the drug company execs and their investors very nervous.
Anti homeopathy activists on social media, and news agencies were ON IT, like flies on you know what... Articles with similar, or worse, fear mongering titles soon peppered social media blogs and Twitter. "Baby deaths due to teething pills" and "Moms, could homeopathic baby teething pills be deadly?" were sandwiched between the presidential political election candidates accusations & turmoil that already had American parents and grandparents on edge. Then this CNN hit piece headlined: Teething tablets may be linked to 10 children's deaths, FDA says was yet another one of many articles.
Until all the dust settles, moms of teething babies have another homeopathic choice, made by Boiron. Boiron Camilia Teething Relief
Walmart stores in the United States now stock many homeopathic remedies by Boiron. Check them out HERE If you do not live near a Walmart store, they do offer free two day shipping.
For updates on Hyland's teething tablets and to contact them via a toll-free number, visit their Facebook page HERE Hyland's has another remedy for teething babies that does not contain belladonna Hyland's, Chamomilla
COMMENTS (to protect their privacy, names have been withheld):
You're right that it may be nothing at all to do with the pills. Presumably we won't know the answer until the contents of the pills have been tested but it appears that Hyland's teething tablets have previously been found to have inconsistent levels of belladonna as well as the pills being in packs that children can easily open. I'm fairly certain that a properly prepared set of pills should be reasonably consistent in their contents. From the FDA's 2010 announcement - "For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps." ~
The FDA has the 'evidence' you are asking about. Do we, the public? Of course not. We also have no information on the vaccine ingredients, the effect of multiple vaccines on infants and children, and no research showing vaccines are not harmful in the doses given. Wait, we had research, didn't we? It was falsified! How about all the drugs that were approved, 'safe and effective' by the FDA, then recalled after many deaths? How about the fact that iatrogenic disease (caused by DRUGS and DOCTORS) is the third cause of death in the US? Why didn't other countries recall the teething tablets? Can you guess? They don't have the vaccine schedule we have, and don't have the autism and death rates we have. There's your 'evidence.' on Baby Teething Tablets & the Feds ~