The U.S. Food and Drug Administration (FDA) urged parents last week to stop using certain Hyland’s homeopathic teething products after laboratory analysis found inconsistent amounts of belladonna than what was on the label.
According to the Jan. 27 news release, the agency is warning consumers that homeopathic teething tablets that contain belladonna pose an unnecessary risk to infants and toddlers. Belladonna is a common ingredient used in homeopathy and alternative medicines but can be dangerous to children.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”
As a result of the findings, the FDA contacted Standard Homeopathic Company in Los Angeles, the manufacturer of Hyland’s homeopathic teething products, about recalling the products to protect consumers. The company has yet to agree to a recall, despite the fact that some tests revealed the toxic substance belladonna in the product far exceeded the amount indicated on the label.
In November, Raritan Pharmaceuticals issued a voluntary recall of its homeopathic products containing belladonna over similar claims that the amount of the extract frequently differed than what was declared on the label.
Consumers were instructed to stop using the products, including CVS Homeopathic Infants’ Teething Tablets, Kids Relief Homeopathic Ear Relief Oral Liquid and CVS Homeopathic Kids’ Ear Relief Liquid.
Teething Tablets Frequent Target of FDA Warnings
The news release from the FDA is just the latest in a string of warnings about the safety of homeopathic teething tablets and gels.
On Sept. 30, 2016, the agency issued a stern warning that the products pose a risk to infants and children. Since 2010, the agency has received more than 400 reports of adverse effects linked to homeopathic teething products that contain belladonna.
“Most describe serious adverse events, like seizures,” said Lyndsay Meyer, a spokeswoman for the FDA, told CNN. “We are also aware of reports of 10 deaths during that time period that reference homeopathic teething products.”
While the deaths have not been directly related to the teething tablets, they are what prompted the warning and are currently under investigation by the FDA.
Woodcock urged parents to look for safer and more effective alternatives.
“Teething can be managed without prescription or over-the-counter remedies,” she said. “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.”
Hyland’s and Others Facing Lawsuits Over Teething Products
After the September warning from the FDA, Hyland’s continued to stand by its teething tablets and gels as safe and effective products.
“Neither we nor FDA have recalled the homeopathic teething tablets or gels,” Hyland’s said on its website in October. “While we are confident that Hyland’s Baby Teething Tablets and Teething Gel remain safe for use, it is up to you to make the decision about the medicines you administer to your child to relieve symptoms of teething.”
Now that the FDA is requesting a recall of the products, it is unclear whether Hyland’s will officially recall the teething tablets and gels.
Hyland’s, along with other manufacturers and sellers of homeopathic remedies, also currently faces a class-action lawsuit over claims that the company marketed ineffective and dangerous teething products.
The complaint was filed Nov. 9 in the U.S. District Court for the Southern District of New York by three women. The plaintiffs, who are suing for a breach of implied warranty of merchantability among other counts, are seeking damages and other compensation.