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Archive for the ‘Hyland’s Teething Tablets’ Category

INTRODUCTION: Homeopathy skeptics maintain that homeopathic remedies are just “sugar pills”. The FDA, however, has warned consumers that inconsistent amounts of a single ingredient (belladonna) in homeopathic baby teething tablets has caused harm. Who should parents of teething babies trust? I have added my voice to this 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 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.”

This abstract of a published research study concluded that a much higher potency of belladonna (30C potency) had only a “placebo” effect.

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.

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.

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Health Canada Issues Statement about Homeopathic Teething Tablets
October 21, 2016 | By Michael Johnsen Source: http://www.drugstorenews.com/article/health-canada-doesnt-share-fda-concern-over-homeopathic-teething-remedies

OTTAWA – Health Canada doesn’t share the same concerns as the Food and Drug Administration when it comes to homeopathic teething remedies, the Canadian health agency announced Thursday.

“At this time, there is no indication of a similar safety concern in Canada,” the agency stated in a release to Canadian citizens. ‘We continue to follow up with Canadian manufacturers and the FDA, and to assess all available information. Should the Department determine that there is a safety concern involving products sold in Canada, we will take action and inform Canadians as appropriate.

There are several homeopathic teething products authorized in Canada, manufactured by different companies and available in multiple formats including gels, tablets and liquids. Health Canada has received 11 Canadian adverse reaction reports involving a variety of these products since their sale: three that were serious but were confirmed, following an assessment, to be unrelated to the product; seven that were not serious; and one that was an allergic reaction that was determined to be possibly linked to the product.

No deaths associated with homeopathic teething products have been reported in Canada.

Parents and care givers with questions or concerns about teething products should speak to a healthcare practitioner, and should seek immediate medical care if their child reacts unusually after using these products.’ ”

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The FDA says that parents should stop using teething tablets because there have been reports of serious adverse events and perhaps deaths because of the inconsistent amounts of highly diluted homeopathic belladonna content in them. Perhaps the FDA should consult a few of the many homeopathy skeptics that maintain homeopathy has only a placebo effect and is therefore useless.

The FDA depends on Laboratory Analysis of Homeopathic Teething Tablets (a ruse) to support their alert. The results in Table 4 are of particular interest. http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm538669.htm

For example, (cited below) the conclusion of this randomized double blind placebo controlled research study, of 253 patients, given homeopathic 30C belladonna was that there was no difference between the homeopathy and placebo groups.

https://www.ncbi.nlm.nih.gov/pubmed/14651731

This case report from France https://www.ncbi.nlm.nih.gov/pubmed/21194906 describes the treatment of a two year old who ingested several berries from a live deadly nightshade plant. The child was seen in the emergency room, kept for observation, treated symptomatically (probably with homeopathy) and released within 48 hours. No permanent adverse effects were documented or reported. I have thus far been unable to find any reported deaths in the literature that could be directly attributed to either the live belladonna berries or the less than 1 mg belladonna content of homeopathic teething tablets.

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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/

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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?

Read Full Post »

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.

Read Full Post »

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?

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