The U.S. Food and Drug Administration (FDA) last week confirmed that laboratory tests found elevated levels of belladonna in samples of homeopathic teething tablets. The FDA urged parents and caregivers to stop giving children the products and safely dispose of any remaining tablets.
Belladonna, also known as deadly nightshade, is a toxic substance and products containing it cause unnecessary health risks for young children, the agency warned in its Jan. 27 announcement. The FDA continues to investigate whether homeopathic teething remedies may have played a role in the deaths of as many as 10 children as well as some other adverse health events over the years.
“The body’s response to belladonna in children under 2 years of age is unpredictable and puts them at unnecessary risk,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement:
“We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professionals for safe alternatives.”
Tablets marketed by Hyland’s Inc. and CVS pharmacies have been at the center of the investigation. Laboratory analysis concluded that levels of belladonna alkaloids in some CVS and Hyland’s tablets “far exceeded the amount stated on the products’ labels.”
Officials have urged caregivers to seek immediate medical attention for children who experience seizures, breathing problems, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficult urination or agitation after using homeopathic teething tablets or gels
Last fall, the FDA announced it was reviewing reports of more than 400 adverse health events among children who used the products, including a case last September in which a child experienced a seizure.
However, officials also stressed that adverse event reports alone do not provide conclusive evidence of problems with products. In a Jan. 30 email, FDA press officer Lyndsay Meyer said the agency would continue to work to determine whether the remedies caused health problems for children who used them.
“Our investigation is still ongoing, and we have not been yet determined a causal link between them, (not saying we will or we won’t, just that we haven’t at this time),” Meyer wrote.
The adverse event reports have been made available online, along with partial lab results from the investigation, Meyer said.
Standard Homeopathic Co., the Los Angeles manufacturer of Hyland’s Teething Tablets, discontinued production of the remedy last fall, CNN reported on Jan. 27.
“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 whom to trust,” Mary C. Borneman, a Hyland’s spokeswoman, told CNN.
Manufacturer Raritan Pharmaceuticals recalled three belladonna-containing homeopathic products, including two that were marketed by CVS pharmacies in November 2016, according to the FDA.
Experts stress that teething is a routine part of early childhood and that there are safe and simple ways to help babies cope.
Want to know more about the ongoing investigation into homeopathic teething products? Want helpful teething resources? Check out this new AHCJ tip sheet.
