Ten children who used what has been described as homeopathic teething tablets have died and another 400 adverse events have been tied to the tablets according to reports to the U.S. Food and Drug Administration (FDA).
The agency warned caregivers to stop using the homeopathic products, which are used to soothe the gums of teething babies. The FDA also warned that caregivers take their child to a doctor immediately if the child experiences problems. The federal regulator is investigating the adverse events and deaths, as “the relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review,” according to its statement, CNN reported.
The products have not been recalled and some of the homeopathic teething products include, according to CNN:
- Hyland’s Baby Teething Tablets, Teething Tablets Nighttime, and Teething Gel
- Baby Orajel Naturals Gel for Teething Pain, Gel for Teething Pain Nighttime Formula, Tablets for Teething Pain
- CVS Homeopathic Infant’s Teething Tablet, Teething Liquid
CVS, one of the drugstore chains that sold the Hyland’s products, Baby Orajel Naturals, and CVS versions of the teething products has removed all products from its shelves after it received an FDA warning. Walgreens also confirmed that, following the FDA warning, it removed homeopathic teething products from its shelves. Hyland, which makes homeopathic teething tablets and gels, just announced that it will cease distributing the products in the United States.
The agency issued a safety alert concerning the tablets in 2010; Hyland’s issued a recall at that time. After FDA laboratory testing, the agency indicated that it discovered inconsistent amounts of belladonna in the tablets and had received adverse event reports consistent with belladonna toxicity associated with the product’s use. The FDA also expressed concern that the bottles did not have child-resistant caps, according to CNN. Adverse events include fever, lethargy, vomiting, sleepiness, tremors, shortness of breath, irritability and agitation. Reports have been received over the past six years.
Hyland’s indicated that it reformulated the teething product to lower how much belladonna was used and also made improvements to 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, CNN reported.
The American Academy of Pediatrics’ HealthyChildren.org warned parents to avoid teething tablets that contain belladonna and to avoid oral gels that contain benzocaine, citing agency warnings and potential side effects, CNN wrote. The American Academy of Pediatrics suggests parents massage their child’s gums with a clean finger; use a solid teething ring or clean, wet washcloth that’s been chilled in the freezer; or use frozen bananas, berries, or bagels when their child is in pain. Parents may also give a weight-appropriate dose of acetaminophen—after speaking with the child’s doctor about the appropriate dose—instead of using teething tablets or gels.
