Last year we told you about a consumer warning issued by the FDA regarding homeopathic teething products that had inconsistent levels of belladonna, which is considered a toxic substance. On Friday, the FDA released a report stating that elevated levels of belladonna have been found in those products; sometimes “far exceeding the amount claimed on the label.”
The government investigated more than 400 reports of adverse effects linked to those products, which ranged from “seizure, death, fever, shortness of breath, lethargy, constipation, vomiting, sleepiness, to tremor, agitation, and irritability.” The FDA has contacted Standard Homeopathic Company in Los Angeles, the maker of Hyland’s homeopathic teething products made with belladonna.
The company has not agreed to a recall. So the FDA recommends that consumers stop using these products marketed by Hyland’s immediately and throw any they have away.
Belladonna is a plant that is also known as deadly nightshade. It is widely regarded as unsafe, even though it has been used in the past as a sedative. The leaves and berries of this plant are “extremely toxic” according to the FDA. The plant contains chemicals that block the functions of the body’s nervous system, which can cause serious side effects. The FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said in a statement, “the body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk. 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 efficacy. And there is no proven health benefit of the products, which are labeled to relieve teething symptoms in children.
If you do choose to use these products, be watchful for any adverse reactions, including seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation. Take your child to a doctor immediately if any of these symptoms occur.
