FDA WARNS: HOMEOPATHIC TEETHING AIDS MAY CAUSE INFANT DEATH

Teething is a normal part of a baby’s development. The discomfort that is caused by teeth erupting from tender gums, however, is distressful for parents and infants alike. Sleepless nights, long bouts of crying, and resistance to eating are all symptoms of teething and signs that a child is experiencing pain. For this reason, many parents turn to teething aids. For decades, they have been used to lessen the pain and ease the teething process.

Homeopathic remedies have become increasingly popular over the years, and many parents believe these are safer for babies than traditional aids. This may not be the case. The U.S. Food and Drug Administration (FDA) has issued a warning, stating a potential danger with homeopathic teething remedies and urging parents to dispose of any of the items they might have in their possession. The products in question are manufactured by CVS, Hyland’s and others, according to the FDA statement.

The latest communication follows a 2010 FDA warning of possible dangers with Hyland’s teething tablets that led to a recall of the product by the company to address the outstanding issues. While the previous issues were resolved, potential adverse events with homeopathic teething products reported to the FDA through its MedWatch programs have caused new concern. These adverse events include 10 deaths, wherein use of homeopathic teething aids was reported.

According to Bloomberg , over the last six years, 400 babies who were given homeopathic teething tablets and gel experienced serious health issues, including seizures, difficulty breathing, fever, sleepiness, lethargy and irritability. Parents and caretakers are being urged to seek immediate medical assistance if a child experiences any of these symptoms in the wake of homeopathic teething tab use.

This is something Mom Madison Tapler said she experienced when she took to Facebook in August 2015, stating that her daughter had seizures after using Hyland’s nighttime teething tabs. The video of her daughter experiencing “head drops and spasms” has been shared over two thousand times, as Tapler urged moms to warn others as to the potential dangers of the products.

About a year later, Nicole Brown posted a similar video of her daughter, Emma. That video has been been shared over 17.000 times.

Of concern for many parents is the ingredient, Belladonna. Though widely regarded as unsafe, belladonna is used as a sedative, to stop bronchial spasms in asthma and whooping cough, and as a cold and hay fever remedy. It is also used for Parkinson’s disease, colic, motion sickness, and as a painkiller.

According to Hyland’s, the amount of Belladonna used in the teething products “is minuscule…. thousands of times below even the therapeutic amounts of Belladonna used in conventional anti-spasmodic medicines…”

While there is no recall in effect for the teething products with the latest advisory, the FDA is recommending that parents stop using the products. The American Academy of Family Physicians (AAFP) distributed the information in its daily SmartBrief to its almost 125,000 members.

CVS voluntarily pulled CVS Homeopathic, Baby Orajel Naturals and Hyland’s Baby Teething products from its shelves.

Hyland Inc. suspended distribution of the products in the U.S. According to CNN, the company did not want to put parents in the position of having to choose whether to trust the organization or the FDA.

“We are fully cooperating with FDA’s inquiry and we’re providing them with all the data we have. We also hope to learn from FDA what facts, if any, the Agency has based its action on,” said Hyland in a press release. The company affirmed that all of its homeopathic products are made in facilities that follow Good Manufacturing Processes.

The FDA said in an e-mail statement to Bloomberg that, while these adverse events provide some information, the investigation is not conclusive at this point.

Whether these items are harmful or not is still to be determined, but do they really help? According to the parents supporting Hyland’s on the company’s Facebook page, they do. The FDA is not so sure.

UPDATE (8/27/15): After speaking with Hylands management yesterday, it's clear that the only thing they're interested in doing is a lot number testing on her lot. Ive filed an adverse reaction form with the fda. Hylands continues to brag about their products safety and that their products have never been PROVEN to hurt anyone, even though our dr has said so and I have a written diagnosis. They said if I want to try for compensation as far as our hospital bills go, I will need to hire an attorney and I felt very discouraged by the manager. Basically she kept repeating their reputation and that if my child has a (previously unknown) sensitivity to one of the ingredients, it's not their fault and they won't label it as a side effect unless there are many others who have experienced this as well. I understand why they have very few cases reported and followed up on. The company makes it extremely difficult to get anywhere with them and the management suggests that there are other things that are wrong with your child, even though the things she listed our dr already had checked for. I am EXTREMELY unhappy in the company's follow-through and WILL be looking for an attorney to fight my daughter's case with. If I dont fight them and I have serious documentation that these tablets were the cause, then anyone else experiencing this reaction won't have a chance taking a stand against this company.Hey ladies! Here is my update on my baby girl who I took to the hospital a couple of weeks ago for head drops and spasms. We saw a neurologist today and he said she looks perfect. We have gone 5 days with no symptoms now. The neurologist believes that the nighttime teething tablets we had just started giving her, caused the seizures. He called them seizures but said they weren't epileptic, that they were likely triggered by the magnesium and/or belladonna in the tablets. We had started giving her the nighttime version about 3 days before her seizures became very obvious and I forgot to bring the bottle to the hospital to give her so she had less seizures up there. I gave her a couple of tablets when we got home that next night and the next day she had more seizures. Then I discontinued use and she had less each day than the day prior and now it's been 5 days seizure free. We didn't even think of those tablets causing any issues because she had the regular ones (not nighttime) several times with no reaction. We really believed that they were completely safe to give her because they were natural. We are relieved it was something that is easy to fix and we appreciate everyone's prayers. I will be contacting the company's legal department to complain and push them to put a warning on them that it could trigger a neurological reaction.Edited to add: She has had an MRI, EEG, CT scan. All came back perfect. I took her to children's hospital where she was looked after by a team of neurologists and I took her to a separate neurologist who diagnosed her. We have looked into every possible condition or cause and the only thing that is possible or likely is that these tablets caused it. The dr especially believes that due to her timing of getting worse lining up with being on the medication for a couple of days and her getting better and becoming symptom free after stopping use.UPDATE 8/27/15:Hylands LIED to me and told me they haven't had any proven issues with their pills, besides the cap being too easy to remove. They LIED to me saying that their products are safe and something else had to have caused my baby's reaction (even though we have written diagnosis from the pediatric neurologist). Here is a statement from the FDA we just found. The FDA states these have more belladonna than is "safe". This company refuses to take responsibility for the damages these tablets have caused my baby and others. Seizures is an adverse reaction LISTED BY THE FDA yet hylands says it's impossible. Here is a warning from the FDA warning of these symptoms:http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm231356.htm

Posted by Madison Tap on Tuesday, August 25, 2015

The Agency stated, “Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.”

In lieu of teething aids, the Mayo Clinic recommends that parents massage their teething babies’ gums, let them bite on a cold washcloth or chilled spoon, or, if the child is eating solid foods, gnaw on a chilled item under close supervision. Pain relievers formulated for children can also be used. Parents should consult their children’s physicians for safe use and appropriate dosages.

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