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Each Hyland’s teething tablet contains 0.0000000000003% of belladonna; whereas 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

Without providing scientific evidence concerning the possible connection between the “inconsistent amounts of belladonna” in Hyland’s teething tablets and adverse effects to either Hyland’s or Standard Homeopathic, the FTC and FDA have continued to claim Hyland’s Teething Tablets are not safe, parents should stop using them and dispose of any tablets in their possession.

All of their 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. 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.”

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 stating “We are Still Awaiting Data Behind FDA Warning.”

I have blogged about this issue HERE with the suggestion that more facts, data and questioning of the circumstances surrounding these claims be questioned. Could these reported adverse events more rightly be placed at the feet of the CDC’s recommended accelerated vaccine schedule and not Hyland’s teething tablets?

A Mom of five blogged her response to this warning: Why I am Not Trowing out my Hyland’s homeopathic teething tablets.

What the FDA did, without any published science to back their warning, was provide powerful ammunition for the anti homeopathy political activists, drug companies, the American Medical Association, and health care consumers DO NEED THEM when appropriate…personal injury attorneys https://twitter.com/ThomasLawKY/status/791652199197609986. The increase in reports of growing demand for natural solutions has most likely been making the drug company execs, and the CDC accountants who depend on vaccine sales to fill their coffers, very nervous.

Anti homeopathy activists on social media, and news agencies (funded by drug companies) 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 in 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 one of many hit pieces.

Homeopath Joette Calabrese blogs about the Hyland’s Teething Tablet issue and the FDA.
http://joettecalabrese.com/blog/trick-and-treating-with-our-teething-tablets/

Fact versus fiction versus homeopathic teething tablets.

Health Canada has NOT issued a similar warning. Read their position HERE

Link to another opinion from The Bolen Report, a science based analysis of the North American health care system: So, why is the FDA picking on Hyland’s teething tablets? is HERE

< < Click to enlarge. I believe that the blame for babies' supposed severe adverse reactions to Hyland's teething tablets and gels by the FDA is incorrect. There are many etiologies in the differential diagnosis that needed to be ruled out. Did the FDA consider the fact that babies are teething during the same time span that the CDC recommends an entire battery of immunizations between the age of birth to 15 months? I have posed other questions. Scroll past the “Birth to 15 Months” image to read them.

The CDC recommended accelerated immunization schedule birth to 15 months (screen shot below and link HERE) is quite an eye opener. Adverse effects to any medication do not occur in a vacuum. As a now retired health care professional and teacher involved in medical records reporting and documentation systems in both private and university medical teaching and training settings for 20+ years, I would suggest that Hyland’s at least know the answers to the questions I pose below the image of the immunization schedule of the CDC. First, however, I need to THANK and include a link to the reaction to the FDA warning about teething tablets by this mother of five!

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 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 hours prior to the reported adverse reaction, did the child have a change in diet or formula?

Each Hyland’s teething tablet contains 0.0000000000003% of belladonna; whereas 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. This can be confirmed by visiting any one of the many online prescription information web sites; or your family physician’s copy of the 2017 Physician’s Desk Reference (PDR).

Without providing scientific evidence concerning the possible connection between the “inconsistent amounts of belladonna” in Hyland’s teething tablets and adverse effects to either Hyland’s or Standard Homeopathic (the manufacturer), the FTC and FDA have continued to claim Hyland’s Teething Tablets are not safe, parents should stop using them and dispose of any tablets in their possession.

All of their 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. 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.” You can access these statements on the web using appropriate Google search terms. (Editorial note: reference is to the online adverse events reporting system used by parents. It is logical to assume that these parents most likely do not connect any adverse events to the vaccines or vaccine their infant may have received within the prior 24 to 48 hours)

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. Use the search terms Health Canada, Teething Tablets, Not concerned.

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 stating “We are Still Awaiting Data Behind FDA Warning.”

I have blogged about this issue with the suggestion that more facts, data and questioning of the circumstances surrounding these claims be questioned. Could these reported adverse events more rightly be placed at the feet of the CDC’s recommended accelerated vaccine schedule and not Hyland’s teething tablets?

A Mom of five blogged her response to this warning: “Why I am Not Trowing out my Hyland’s homeopathic teething tablets”

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 the CDC accountants who depend on vaccine sales to fill their coffers, very nervous.

Anti homeopathy activists on social media, and news agencies (funded by drug companies) 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 in 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 one of many hit pieces.

Health Canada doesn’t share the FDA concern over homeopathic teething remedies http://www.drugstorenews.com/…/health-canada-doesnt&#8230; Homeopathy and homeopathic teething tablets are sold worldwide. To my knowledge, no other country’s drug safety and use regulator, has issued a similar warning. Hyland’s baby teething tablets have been offered to consumers since the early 1900s.

It is important to note that the amount of belladonna in each homeopathic teething tablet is 0.0000000000003% (less than 1 mg). Per the 2016 Physician’s Desk Reference (PDR); a single FDA approved B&O suppository contains 16.2 mg of Belladonna; a significantly higher amount than the homeopathic belladonna content in more than ten baby teething tablets containers. Source: https://www.drugs.com/pro/belladonna-

Hylands issued a statement noting that the FDA has not provided scientific proof that the “inconsistent amounts” of belladonna in teething tablets are causing the adverse reactions. The FDA needs to consider the fact that babies are teething during the same time period (3-15 months of age) that they are receiving multiple vaccines, including the controversial MMR vaccine. Since the CDC has recommended an accelerated vaccination schedule, could this be the culprit instead?