The Food and Drug Administration (FDA) announced that the laboratory analysis found inconsistent amounts of belladonna in some homeopathic teething tablets, with levels higher than what is claimed on the label. Consumers are being warned to not use homeopathic teething tablets containing belladonna as they pose an unnecessary risk to infants and children.
Standard Homeopathic Company, the manufacturer of Hyland’s homeopathic teething products, was contacted by the FDA regarding a recall of its products labeled as containing belladonna in order to protect consumers from inconsistent levels. The Company has not agreed to conduct a recall thus the FDA recommends consumers to discontinue and dispose of these products marketed by Hyland immediately. Another company, Raritan Pharmaceuticals, had recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.
Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, cautioned, ”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.” The safety and efficacy of homeopathic teething products have not been evaluated or approved by the FDA. These products are labeled to relieve teething symptoms in children but the FDA warned against the use of these products in September 2016 after receiving reports of adverse events.
If the child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething products, medical care should be sought immediately.
For more information call (888) 463-6332 or visit FDA.gov.