The U.S. Food and Drug Administration (FDA) is once again pushing for a recall of homeopathic teething products now that the government agency issued a new report that certain brands contain a toxic substance called belladonna, which comes from the deadly nightshade plant as its hallucinogenic qualities can be poisonous. The FDA recommends that consumers stop using certain homeopathic teething products that contain belladonna, specifically a tablet from the brand Hyland's, adding that the company has refused to recall the products. Romper reached out to the product’s manufacturer, Standard Homeopathic Company in Los Angeles, and is awaiting a response.
“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 FDA said in a statement on Friday.
According to CNN, the company said it has not agreed to the recall because it discontinued the sale of this product in the United States on Oct. 7. “We discontinued it because we are committed to our moms and our dads who choose to trust us to put medicines in their young infants' mouths, and we didn't want to put them in a place between the FDA warning and us saying the product was safe and having to decide who to trust," Mary C. Borneman, a spokeswoman for Hyland's, told CNN.
Homeopathic teething tablets have been around for over 100 years as a way to provide temporary relief to babies growing their first teeth, but many studies have shown that homeopathic products do not provide the health benefits that are marketed and the FDA does not approve of these products, according to NBC News.
This warning against homeopathic teething products isn’t the first: In September 2016, the FDA warned parents against the use of these products after receiving adverse event reports and in November 2016, Raritan Pharmaceuticals recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.
"The body's response to belladonna in children under 2 years of age is unpredictable and puts them at unnecessary risk," Dr. Janet Woaodcock, director of the FDA's Center for Drug Evaluation and Research, said in Friday’s statement. "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 FDA told CNN that it has received more than 400 reports of adverse events linked to teething products that contain belladonna and "10 deaths during that time period that reference homeopathic teething products," which are currently under review.
The warning comes after reports of seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, and agitation and the agency urges parents to seek medical attention immediately if their children experience any of these symptoms.
Every parent can agree that ensuring their child's safety is their most important job and the FDA's latest warning might help make this a little bit easier. Before using a certain homeopathic teething product to ease your little one's pain, simply check labels for "belladonna" or just check with your own doctor for alternative methods for pain relief.