US FDA warns against high belladonna content in certain homeopathic products
30 January 2017
The US Food and Drug Administration announced on Friday 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.
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 labelled as containing belladonna. At the time, the company had 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 in 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, MD, 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 said it is unaware of any proven health benefit of the products, which are labelled to relieve teething symptoms in children. In September 2016, the FDA warned against the use of these products after receiving adverse event reports.
It asked consumers to seek medical care immediately if their child experiences seizures, difficulty in breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething products.
The FDA encouraged healthcare 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 at www.fda.gov/medwatch/report.htm.