WASHINGTON -- Ten deaths of children who used homeopathic teething tablets and 400 adverse events associated with the tablets have been reported to the US Food and Drug Administration, the agency said Wednesday.
The FDA warned caregivers to stop using the products, which parents use to soothe teething babies, and to take their child to a doctor immediately if the child experiences problems.
The agency is investigating the adverse events and the cases involving the deaths, as "the relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review," according to a statement.
The deaths and adverse events -- including fever, lethargy, vomiting, sleepiness, tremors, shortness of breath, irritability and agitation -- occurred over the past six years.
In a statement emailed to CNN, Hyland's, a maker of homeopathic teething tablets and gel, said: "Hyland's has not been made aware of any data that supports the claims in the warning against our teething tablets and gels. Our understanding is that the Food and Drug Administration's investigation of these products is still ongoing. The fact is that we have not been made aware of any medical or statistical evidence to support a causal link between homeopathic teething tablets and adverse outcomes at this point. We continue to request any available information and statistics from the FDA.
Hyland's said this week that it will stop distributing the products in the United States.
The company said in a letter posted on its website Tuesday that it chose to discontinue US distribution of its teething products.
"This decision was made in light of the recent warning issued by the Food & Drug Administration against the use of homeopathic teething tablets and gels. This warning has created confusion among parents and limited access to the medicines," the letter from Hyland's employees said. "Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA."
There is no recall on the products, including Hyland's Baby Teething Tablets, Hyland's Baby Teething Tablets Nighttime and Hyland's Baby Teething Gel. CVS, one of the drugstore chains that sold Hyland's, Baby Orajel Naturals and its own version of the teething products, pulled all of them from the shelves after the FDA warning. Walgreens also confirmed that it has withdrawn homeopathic teething products that were subject to this FDA warning.
"We are confident that any available Hyland's teething products, including those you already have, are safe for use," the Hyland's letter said. "Of course, parents who may have concerns should consult with their physicians before using any medicines, read labels carefully and follow all instructions.
"We look forward to the future of homeopathic medicines as we work in partnership with the FDA," the letter said.
The FDA issued a safety alert about the tablets in 2010, and Hyland's issued a recall at that time. After lab testing, the FDA said it found inconsistent amounts of belladonna in the tablets. The agency also had reports of adverse events related to using the products that were consistent with belladonna toxicity. The FDA also was concerned because the bottles didn't have child-resistant caps.
Since 2010, Hyland's said, it reformulated the product to reduce the amount of belladonna and revamped its production process. "We also improved our system to monitor, investigate and trend all safety reports on any of our products. We have not seen any trend to indicate that Hyland's teething medicines pose any risk to consumers," it said on its website.
The American Academy of Pediatrics' HealthyChildren.org has warned parents to stay away from teething tablets that contain belladonna and gels with benzocaine, citing the FDA warnings and the potential side effects.
Instead of teething tablets or gels, the American Academy of Pediatrics suggests that parents massage the child's gums with a clean finger when a baby is in pain; use a solid teething ring or clean, wet washcloth that's been chilled in the freezer; frozen bananas, berries or bagels. Parents can also give a weight-appropriate dose of acetaminophen, but should ask the child's doctor about an appropriate dose.
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Teething tablets may be linked to 10 children's deaths, FDA says