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The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.
FDA is looking into the deaths and 400 “adverse events” reported to the agency.
The Agency is warning parents and caregivers to seek medical care immediately if an infant or child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels. It is also advising consumers to dispose of any such products they may have in their possession. Medical review of the data and other information remains ongoing, and no definitive causal link between the products and the adverse events or deaths has been established.
Following the FDA warning on September 30th, CVS Health announced that it was voluntarily removing all homeopathic teething products from its retail pharmacy stores. Other retailers, such as Walgreen’s, are reportedly considering whether to take actions as well or have already done so. In addition, the manufacturer with the largest market share of these products, Hyland’s, released a statement on October 11th regarding its decision to stop distributing them in the U.S. in response to FDA’s action.
In its September 30th press release, the Agency explained: “Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.”
Health Canada is aware of the FDA warning and is looking into the issue, Health Canada spokesman Eric Morrissette said Thursday in an e-mail.
“Parents and caregivers with questions or concerns about teething products for their children should speak to a health-care professional, such as a pharmacist,” Mr. Morrisette said.
Agencies/Canadajournal
