Homeopathic Teething Tablets and Gels - Potential Risk of Harm to Infants and Children
October 10, 2016
FDA issued a warning about the risk of adverse effects from all homeopathic teething tablets and gels. Products include those sold by CVS, Hyland’s, and other retail and online marketplaces. FDA received additional reports of adverse events regarding homeopathic teething remedies since issuing a consumer safety report in 2010. The Hyland’s product involved in the 2010 consumer safety report was analyzed. This analysis revealed inconsistent quantities of belladonna. Reported adverse events were consistent with belladonna toxicity. Adverse events included seizures, difficulty breathing, muscle weakness, difficulty urinating, constipation, lethargy, excessive sleepiness, skin flushing, and agitation.
FDA expanded the warning to include all homeopathic teething tablets and gels. FDA is analyzing adverse event reports and testing product samples. FDA is not aware of any proven benefit from these products, but has not formally evaluated their safety and efficacy. FDA advised consumers to avoid giving homeopathic teething tablets or gels to infants and children. Dispose of any homeopathic teething tablets and gels. Report adverse effects to the FDA MedWatch Adverse Event Reporting Program.
- MedWatch Safety Alert – September 30, 2016
- FDA News Release – September 30, 2016
- MedWatch Safety Alert – October 23, 2010
October 10, 2016; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.