Hyland’s homeopathic teething pills and gels sickened at least 370 children between 2006 and 2016, according to a new investigate report published by STATNews.com. Eight children died after exposure to the homeopathic teething remedies, but federal drug regulators are still working to determine if the Hyland’s products played a role in any of the fatalities.
STATNews.com utilized a Freedom of Information Act request to access information on teething tablets injuries and deaths from the U.S. Food & Drug Administration’s (FDA) adverse event database. Some of the injured infants and toddlers suffered seizures after ingesting a Hyland’s teething products, and some became delirious. The review of the information revealed at least one case where a child was airlifted t the hospital.
In 2010, the FDA announced a recall or Hyland’s Teething Tablets, after they were tied to a number of adverse event reports consistent with belladonna toxicity. According to RXInjuryHelp.com, belladonna is used in many homeopathic remedies because it has a sedative effect in small doses. But t0o much is toxic and can lead to complications like seizures, breathing difficulties and even death.
In September, the FDA warned parents and caregivers against the use of homeopathic teething pills and gels due to the number of adverse event reports it had received in relation to such products. Standard Homeopathic, Hyland’s parent company, did announce it would no longer sell its teething tablets in the U.S., citing the “confusion” purportedly created by the first FDA warning. However, no recall was issued.
In January, the FDA issued a warning specifically for Hyland’s homeopathic teething tablets, after it confirmed that they contained inconsistent amounts of belladonna.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a press release issued by the agency at the time. “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.”
For its part, Hyland’s continues to insist its products are safe, and has not agreed to issue any recall.
“That doesn’t mean that children don’t have a sensitivity to a product. There is a lot of sensitivity on kids’ parts and we have to watch carefully,” a company spokesperson told StatNews.com. “It’s not something that condemns the entire product line.”
Bernstein Liebhard LLPP is evaluating personal injury lawsuits and wrongful death claims involving Hyland’s Teething Tablets and other homeopathic teething remedies. To discuss a case with a member of our legal team today, please call (888) 870-9331 to arrange for a free, no-obligation review.