FDA: The U.S. Food and Drug Administration announced today 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 is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.
In light of these findings, 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,
in order to protect consumers from inconsistent levels of belladonna. At
this time, the company has not agreed to conduct a recall. The FDA
recommends that consumers stop using these products marketed by Hyland’s
immediately 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.
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.”
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.
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.
encourages health care professionals and consumers to report adverse
events or quality problems experienced with the use of homeopathic
teething products to the FDA’s MedWatch Adverse Event Reporting program: