Ten deaths and 400 adverse events have been reported to the Food and Drug Administration (FDA) involving children who have taken Hyland’s homeopathic teething tablets, a small, white, quick dissolving tablet that contains ingredients used to soothe the pain and soreness occurring when children are getting their baby teeth. Side effects including fever, lethargy, vomiting, sleepiness, tremors, shortness of breath, irritability, and agitation have been reported in children over the past six years.
The FDA is currently reviewing the cases of the ten deaths that claim to be linked to using the drug. During this time, they have warned caregivers to stop using the products and take their child to a doctor immediately if the child experiences problems. Production of the product has been discontinued in the United States and inventory has been pulled from the shelves in popular drugstore chains such as Walgreens and CVS Pharmacy. Currently, there is no official recall issued on the products.
Hyland’s released a statement saying that they have “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 that the company decided to discontinue distribution of the products until the FDA’s investigation was complete, stating that they did not wish to create any confusion for consumers or undermine the FDA’s warning. “We are confident that any available Hyland’s teething products, including those you already have, are safe for use,” Hyland’s said. “Of course, parents who may have concerns should consult with their physicians before using any medicines, read labels carefully, and follow all instructions.”
The FDA previously issued a safety warning about the tablets in 2010, after lab testing found inconsistent amounts of belladonna in the tablets. The agency also had reports of adverse events that were consistent with belladonna toxicity. Additionally, the FDA was concerned because the bottles did not have child resistant caps. Hyland’s reformulated the product and changed the caps on their bottles.
The American Academy of Pediatrics suggests that parents avoid use of teething tablets containing belladonna and gels with benzocaine and treat teething pain with cold teething rings and washcloths or frozen bananas, berries, or bagels. Parents can also use the proper dosage of children’s acetaminophen to help relieve the lingering soreness.
If you wish to learn more about the FDA’s review of homeopathic teething tablets or how you can protect your children from harmful products, contact Thomas Law Offices for more information. We can pair you with a Louisville, KY product liability lawyer who can answer any questions you may have.