FDA Warns of Elevated Levels in Belladonna in Various Homeopathic Teething Products

January 31, 2017

On Friday, January 27th, the FDA published a press release warning consumers of elevated levels of belladonna in certain homeopathic teething products. According to the announcement, an FDA-conducted laboratory analysis found "inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label." As such, the Agency is warning consumers not to use Hyland's homeopathic teething products, stating that they could pose an unnecessary risk to infants and children.

According to an article published by CNN, the product was discontinued on October 7th by Standard Homeopathic Co., the company that manufactures Hyland's. However, after uncovering its recent findings, the FDA contacted Standard Homeopathic Co. regarding a recall of its teething tablets, but the company has not agreed to conduct a recall at this time.

In November 2016, Raritan Pharmaceuticals, located in East Brunswick, New Jersey, "recalled belladonna-containing homeopathic products, two of which were marketed by CVS."

A History with the FDA

In 2010, the FDA conducted its first laboratory analysis of Hyland's Teething Tablets, which showed that the product contained inconsistent amounts of belladonna. At that time, the Agency issued its original safety alert warning consumers not to use these products. Since then, CNN states that "the Agency has received more than 400 reports of adverse events linked to teething products that contain belladonna." According to CNN, Lyndsay Meyer, a spokeswoman for the FDA, stated that most of the side effects that were experienced and reported were serious events, such as seizures. Additionally, Meyer also stated that the FDA was made aware of ten deaths that reference these homeopathic teething products.

FDA's Involvement Today

"Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children." In September 2016, the FDA issued an additional notice warning consumers against the use of these products.

In a statement made by Hyland's, Mary C. Borneman, the company's spokeswoman, stated that Hyland's Teething Tablets "are a top-selling products and a consumer favorite." She also said that the company stands by the safety of the product, and sadly this situation has "resulted in the loss of 24 jobs."

FDA's press release states that 'the body's response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk.' Furthermore, the Agency recommends "that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives."

It will be interesting to see what the future holds for Hyland's homeopathic teething tablets and other similar products containing belladonna. For additional information, view FDA's full press release.

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