The tablets contain inconsistent amounts of belladonna alkaloids that may differ with labels
The recalled products were previously linked to the deaths of 10 children
Any remaining Hyland’s homeopathic teething products are now being removed from store shelves under a major recall.
Two types of the teething products, which previously were linked to the deaths of 10 children, have been recalled, the Food and Drug Administration announced on Thursday.
Standard Homeopathic Company, the Los Angeles-based maker of Hyland’s homeopathic teething products, recalled all of its teething tablets and nighttime teething tablets, the announcement said. The FDA concluded that the products have mislabeled the amounts of belladonna alkaloids they contain.
After the FDA warned parents against using homeopathic teething tablets and gels last year, the company had announced in October that it would stop distributing the products in the United States.
Dr. Natasha Burgert, a Kansas City-based pediatrician, said that many parents of her patients have asked her about the latest recall.
“Belladonna is a natural plant that has been used for centuries,” she said.
Burgert added that while belladonna can be harmful, “my suspicion is that, when using it in teething tablets at homeopathic doses, the likelihood of a significant reaction is likely low,” she said. “However, I think it is appropriate for the FDA to be concerned that these homeopathic tablets and regimens are not regulated.”
In January, the FDA urged parents not to use Hyland’s homeopathic teething products after finding that the products contain varying amounts of belladonna, a toxic substance, commonly known as deadly nightshare, that can be harmful to children.
Ten deaths and other adverse events, such as seizures and vomiting, previously were reported to the FDA and the agency investigated those reports last year.
As part of the recall, parents are encouraged to throw away any teething products they may still have.
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“We initiated this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested,” said J.P. Borneman, chairman and CEO of Standard Homeopathic Company, in the announcement.
“We are committed to maintaining and earning the trust consumers have placed in Standard Homeopathic Company. We have worked for 114 years to build relationships with our consumers. We intend to preserve that tradition of trust,” he said.
This isn’t the first time that Hyland’s teething tablets have been recalled. In 2010, Standard Homeopathic voluntarily recalled the tablets to address concerns with the product’s manufacturing process and refine its production, packaging and testing protocols.
At the time, adverse events were reported, but the FDA said that it could not confirm a conclusive link between the events and the teething products.
Hyland’s homeopathic teething tablets date back to 1945, when they were introduced to the US market and have been used by millions of children, according to the company’s website.
Teething usually begins when a baby is between six and eight months old.
Signs of teething include acting irritable, biting or chewing, drooling, gum swelling and tenderness, refusing food, and sleeping problems.
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“Teething is not a medical problem. Teething is natural, it’s important, and the vast majority of kids really do great,” said Burgert, who is also a spokesperson for the American Academy of Pediatrics.
“So, teething isn’t something that parents should be worried about or something that needs tremendous action plans, however, if they do notice their kids are fussy and biting on things we can address them in many ways,” she said.
To ease your baby’s teething discomfort, the American Academy of Pediatrics has some suggestions:
- Try gently rubbing or massaging the gums with one of your fingers.
- Teething rings can be helpful, but they should be made of firm rubber.
- Pain relievers that you rub on the gums are not recommended since they wash out of the baby’s mouth within minutes.
- If your child seems unusually irritable or has a fever, consult your pediatrician.
- Avoid teething tablets that contain belladonna and gels with benzocaine.