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FDA Warns Parents Not to Use Popular Teething Tablets and Gels

4 comments

Popular homeopathic teething tablets and gels have been linked to the deaths of 10 children and 400 adverse reports. The U.S. Food and Drug Administration (FDA) issued a warning to caregivers to stop using the products. The deaths and adverse events, which included fever, lethargy, vomiting, sleepiness, tremors, shortness of breath, irritability, and agitation, occurred over the past six years.

TorHoerman Law is warning anyone that has any of the following products in their home to discontinue use and to speak to a doctor about an appropriate replacement for infant teething relief:

  • Baby Orajel Naturals Gel for Teething Pain, .33 oz
  • Baby Orajel Naturals Gel for Teething Pain Nighttime Formula, .33 oz
  • Baby Orajel Naturals Tablets for Teething Pain, 125 Count
  • CVS Homeopathic Infant’s Teething Tablet, 135 Count
  • CVS Homeopathic Infants’ Teething Liquid, .85 oz
  • Hyland’s Baby Nighttime Teething Tablets, 135 Count
  • Hyland’s Baby Teething Gel, .5 oz
  • Hyland’s Baby Teething Tablets, 13 Count
  • Hyland’s Baby Teething Tablets, 135 Count
  • Hyland’s Teething Gel, .33 oz

If your child has experienced a seizure, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels, seek medical care immediately. TorHoerman Law is now filing teething product lawsuits on behalf of children that had serious seizures and believe it was linked to one of the above teething tablets or gels.

Hylands Homeopathic Defies FDA Advise – Claims Homeopathic Teething Tablets and Gels are Safe

Following the FDA warning, Hyland’s Homeopathic announced that it would voluntarily stop distributing homeopathic teething tablets and gels in the U.S. The company stated that that the FDA warning has “created confusion among parents and limited access to medications,” according to the company’s website.

Despite the FDA’s warning to consumers to dispose of any homeopathic teething tablets or gels in their possession, Hyland’s website still says that they are “confident that any available Hyland’s teething products, including those you already have, are safe for use.”

CVS and Walgreens Voluntarily Pull Homeopathic Teething Tablets

Although there has been no recall of the homeopathic teething tablets, both CVS Pharmacy and Walgreens both confirmed that they voluntarily removed the products recommended by the FDA.

Belladonna Safety Concerns

Homeopathic teething tablets and gels have been reported to contain “belladonna” which is believed to be the link to child seizures and death. Belladonna is a poisonous plant; also known as deadly nightshade, whose roots and leaves are used to make a variety of medicines such as sedatives, cough suppressants and painkillers.  According to the National Institute of Health, belladonna is likely unsafe when taken by mouth.

In 2010, Hyland’s issued a voluntary recall following the first safety alert issued by the FDA regarding the teething tablets. The FDA conducted lab testing and confirmed that it had found inconsistent amounts of the ingredient belladonna in the tablets. Following the 2010 alert, Hyland’s reformulated the product to reduce the amount of belladonna in their products, changed the production process, and claimed to have not seen any trend that indicated that the medicines pose any risk to consumers.

Homeopathic Treatments Aren’t Tested or Regulated by the FDA

It is important for parents to understand that “homeopathic” isn’t just another word for “natural” or “organic”. Homeopathic is a very specific subgroup of alternative medicines that has not been proven to be safe or effective. They are not tested or regulated by the FDA. Instead, homeopathic drugs must meet the standards established by the same people who profit from them – the Homeopathic Pharmacopoeia of the United States (HPUS). Members, who are in the business of homeopathy, govern the HPUS.

Since belladonna is currently included in the HPUS “official homeopathic drug” list, it may be legally included in homeopathic medicines, even those given to infants.

4 Comments

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  1. Nancy Herman says:
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    This is so much baloney. These are children that were given vaccines, most likely. The teething tablets have been given to children around the world for many decades, and we’re expected to believe they caused this? No, it’s the garbage we’re pumping into our children, toxins that their bodies cannot handle. Homeopathic belladonna did not cause these seizures.

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      Nancy, thank you for your note, and for questioning what you read. We are always open to this type of a challenge. Please understand that it is the FDA who is telling parents to toss out these homeopathic teething tablets and gels, not lawyers. We are helping to get word out and welcome others to help us do so, while considering whether Hyland’s Homeopathic needs to be held accountable for these injuries.

      Belladonna is referred to as “the deadly nightshade” – you can find it listed in the FDA “Poisonous Plant Database.” Hyland’s Homeopathy admits that they include Belladonna in these products that they sell for use on infants. They have a video on their website that explains how they “dilute” the deadly plant for use in these products. The FDA announcements note that the amount of Belladonna used in these homeopathic products are elevated and have exceeded the amount that Hylands notes they use on their label and in their advertising.

      We agree that as a society, there are many toxins thrown at our children and that is a shame, but, these are infants who have had very little time/opportunity to ingest a lot of toxins. If you have had children, consider what they had eaten by the time they reach 3 to 6 months, not a ton of processed food.

      The FDA noted that “the body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk” so you have to consider that this may be the cause of these seizures (as opposed to another toxin from a different source). The FDA received a number of adverse event reports that included seizures and death and it appeared that these homeopathic teething tablets/gels were connected. Since it appeared to be a risk that was not warned about, the FDA spoke up. That is what the FDA is charged to do.

      Whether or not the belladonna found in Hyland’s Homeopathic products actually caused these seizures may ultimately be a job for the courts. TorHoerman Law holds companies responsible for the injuries their products cause when such companies put profit ahead of safety. We look forward to building a case against this company if they did in fact put the most vulnerable of our society at risk, infants.

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    Homeopathic remedies have been used safely for 200 years. This particular remedy is made from such minute quantities of Belladonna that is is safe even for infants. The FDA is an arm of the Pharmaceutical industry. They constantly approve drugs that go on to kill many, sometimes thousands of people.
    According to a study in the AMA journal, prescription drugs are the 4th leading cause of death in the U.S. Homeopathy is used safely by 500 million people around the world, to good effect. Over 200,000 board certified homeopathic physicians practice homeopathy in India curing everything from Dengue fever to Leprosy. Also 42% of British medical doctors refer their patients to a homeopath. The remedies are prescribed by 39% of French physicians, 20% of German physicians and 40% of Dutch doctors. The FDA is trying to close down homeopathy because it competes with conventional drugs both conceptually and in the marketplace.

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    Alan, we don’t disagree with you regarding adverse events and the pharmaceutical industry. We represent individuals harmed by dangerous drugs and devices without warning every day. We also personally use many homeopathic healing techniques in our homes and believe in them. This article and the warnings we are putting out to the public are not intended to be a slam on homeopathy in general. However, we believe in holding all companies accountable for the harm they do to unknowing victims when they were aware of the risks their products could cause individuals, and in this situation, infants. We hope you agree with this statement. There has been evidence brought to us that Hylands Homeopathy put out a dangerous product and it needs to be investigated further. But first and foremost, the product needs to be removed from homes. While teething is painful and a difficult time for infants and parents, we strongly believe that for teething the Hippocratic oath should apply. “First do no harm.”

    We agree that homeopathy has been around for 200 years and many products are safe. But, as a teacher of homeopathy, I am sure you are aware of the fact that certain plants used in homeopathy are toxic in nature and must be carefully diluted. Since homeopathy is not regulated by the FDA in the same way as drugs, the claims of how much of the sometimes toxic substances used in the homeopathic products is determined by the company themselves.

    We take strong issue with your statement, “This particular remedy is made from such minute quantities of Belladonna that it is safe even for infants.” The FDA strongly disagrees and the FDA conducted lab studies that determined there were “inconsistent amounts of belladonna” “sometimes far exceeding the amount claimed on the label” in the products they tested