Hyland’s, the maker of homeopathic teething tablets and gels, said this week that it will stop distributing the products in the United States. The change comes after a US Food and Drug Administration warning that caregivers should stop using the products for teething babies.
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.
“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 is looking into reports of adverse events related to the products, including children who may have had seizures after using them. The agency warned that the tablets and gels “may pose a risk” to infants and advises parents to take their child to a doctor immediately if they experience these seizures or difficulty breathing, lethargy, muscle weakness, excessive sleepiness, constipation, skin flushing, agitation and/or constipation.
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.