On January 27, 2017, the FDA announced that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency warned consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urged consumers not to use these products.
Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children. In September 2016, the FDA warned against the use of these products after receiving adverse event reports.
In order to protect consumers from the inconsistent levels of belladonna, the FDA contacted Standard Homeopathic Company in Los Angeles, the manufacturer of Hyland’s homeopathic teething products, regarding a recall of its homeopathic teething tablet products labeled as containing belladonna. As of January 2017, the company had not agreed to conduct a recall. The FDA recommended that consumers immediately stop using these products marketed by Hyland’s and dispose of any in their possession. In November 2016, Raritan Pharmaceuticals (East Brunswick, New Jersey) recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”
Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething products.
See the FDA Announcement
See the FDA Safety Alert
See also Medical Law Perspectives, August 2015 Report: Pediatrician Liability Involving Diseases and Conditions of Childhood
See also Medical Law Perspectives, April 2013 Report: Complementary and Alternative Medicine: Practitioner Liability