Certain brands of "homeopathic" teething products contain belladonna, a toxic chemical, and shouldn’t be used, the U.S. Food and Drug Administration said Friday.
The company that makes Hyland’s homeopathic teething products has refused to recall them so the FDA said it was issuing a warning.
“Laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label,” the FDA said in a statement.
They’re made by Standard Homeopathic Company in Los Angeles.
Belladonna is an extract of the deadly nightshade plant. It has hallucinogenic qualities and is toxic in large amounts.
“The body’s response to belladonna in children under 2 years of age is unpredictable and puts them at unnecessary risk,” said Dr. Janet Woodcock, 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.”
Many studies have shown that homeopathic products do not benefit health in the ways they are marketed or even at all. The FDA does not approve such products but it can work to get dangerous food or drug products of any kind removed from the market.
“Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children,” the FDA said.
“The FDA recommends that consumers stop using these products marketed by Hyland’s immediately and dispose of any in their possession,” the FDA added.
“In November 2016, Raritan Pharmaceuticals (East Brunswick, New Jersey) recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.”
The FDA also gave advice to parents.
“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 products.”
Hyland's withdrew teething products in October, after the last FDA warning.
"We voluntarily discontinued it," said Hyland's spokeswoman Mary Borneman. "We are not aware of who might still be selling teething medicines," she added.
"We are not selling the product. It's not available."
But Borneman said the company has no evidence the products are not safe. She said the FDA never asked them to recall the products. "We don't feel like any action is necessary at this point," she said.
The company has declined to tell customers to dispose of the products if they have them or find them on store shelves.
"We are confident that any available Hyland’s teething products, including those you already have, are safe for use," the company says in a statement still up on its website dating back to October.
"The FDA raised concerns about the safety of homeopathic teething tablets and gels in September 2016. At that time, Hyland's made the difficult decision to discontinue its top-selling and consumer favorite teething medicines," Hyland's said in the statement.
The company denies the teething products are dangerous, but also does not know whether they work. "We do not do efficacy testing on homeopathic medicines," Borneman said.
"We made this decision despite our confidence in the safety of the products and a lack of evidence by the Agency of their claims. Four months later, their report affirms our own tests that show the medicines are well within the margin of safety. Given this, we see no factual basis for FDA’s press release," it added.