On 30 September 2016, the U.S. Food and Drug Administration (FDA) issued a news release warns against the use of homeopathic teething tablets and gels because they may pose a risk to infants and children. The FDA recommended that consumers stop using these products and dispose of any in their possession:
Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.
Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.
“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”
The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.
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.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA’s MedWatch Adverse Event Reporting program:
The Hylands brand of teething tablets, which was recalled in 2010 for causing adverse effects in children (due to its containing inconsistent amounts of belladonna), responded to the FDA advisory by asserting their products are safe:
We want you to know that we are confident that Hyland’s Baby Teething Tablets remain safe. Of course, parents who may have concerns should consult with their physicians before using any medicines, read labels carefully and follow all instructions.
Homeopathic medicines are regulated as drugs by 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.
Our Baby Teething Tablets, like all Hyland’s branded homeopathic medicines, are made in facilities that follow current Good Manufacturing Practices and are inspected by the FDA in the same way as other OTC drugs are. You may use them with confidence. We test our products for their belladonna content as well as other tests including microbial contamination. We also have a program to monitor, investigate, and trend all safety reports on any of our products.
We have seen rumors that circulate regarding the safety of belladonna — an active ingredient in Hyland’s Baby Teething Tablets — and we know that these warnings can cause fear and worry. This new FDA statement increases the confusion. The safety and effectiveness of Hyland’s natural homeopathic medicines is our top priority. That’s why we work with regulators to ensure that our products meet the highest standards. If we ever had reason to be concerned of that safety, we would act immediately.
We think it’s important that you have the facts around homeopathically-prepared belladonna:
• The amount of Belladonna used in Hyland’s Baby Teething Tablets is miniscule. There’s two trillionths of a milligram in a tablet.
• A child would have to eat multiple bottles at once to experience the first side effect of belladonna, which is typically dry mouth.
• To better understand homeopathically-prepared belladonna, please see this video: