The FDA is investigating more than 400 reports of adverse events associated with homeopathic teething products in the last six years, Lyndsay Meyer of the FDA’s Office of Media Affairs told Food Poisoning Bulletin. In addition, they are “aware of reports of 10 deaths during that time period that reference homeopathic teething products, though the relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review,” she stated.
On September 9, 2016, the FDA received a comprehensive report of a recent adverse event of a child having a seizure associated with the use of a homeopathic teething product, triggering an investigation. Other adverse events reported to the government included “seizure, death, fever, shortness of breath, lethargy, constipation, vomiting, sleepiness, tremor, agitation, and irritability.”
On September 30, 2016, the government released a report warning parents about possible “serious effects” of these products. Some homeopathic teething tablets and gels are made with belladonna, a compound that blocks functions of the central nervous system. It seems that some of these products can contain varying amounts of belladonna, which is “widely regarded as unsafe,” according to Web MD, and can cause serious harm at larger doses. These products are not evaluated by the government for safety or efficacy before they are sold, according to the 2010 FDA report.
This is an ongoing investigation. Government officials “have not yet completed the analysis of products to determine if there is an association between the adverse events and the homeopathic teething products.” However, Ms. Meyer did state that “our preliminary review shows that these adverse events are similar to those observed in 2010 when the FDA warned of belladonna toxicity associated with Hyland’s Teething Tablets, when we also issued a warning to protect the public health.”
Ms. Meyer also stated that while adverse event reports give some information about a product, they often indicate situations that “require additional analysis and do not constitute conclusive evidence of a problem with the product.” Adverse events may also be attributable to other problems, such as a patient’s underlying health conditions. And the number of adverse events identified with a product can change as the investigation continues and more information becomes available.
At this time, the FDA recommends that parents do not give their children homeopathic teething tablets and gels. Symptoms of problems associated with these products include difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, and agitation after using the product. Your child should be taken to a doctor if any of these symptoms develop.
If you have purchased any homeopathic teething products, do not use them. Throw them away or take them back to the place of purchase for a refund. After the FDA’s warning, CVS voluntarily removed all homeopathic teething products from their stores. These products may have been sold at other stores and online.
You can report any adverse effects to the FDA through their MedWatch Adverse Event Reporting System. An online form is available at the FDA web site.