The U.S. Food & Drug Administration (FDA) is urging consumers to dispose of Hyland’s Teething Tablets, after testing confirmed the homeopathic remedies contain inconsistent amounts of potentially toxic belladonna. Despite the serious risks these teething pills pose to infants and children, the Standard Homeopathic Company has not agreed to issue a recall for the products.
According to a news release issued by the FDA last week, Hyland’s Teething Tablets could contain more belladonna that what is noted on the product label. This could cause seizures, excessive sleepiness, muscle weakness and skin flushing in children.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”
In September, the FDA warned parents and caregivers against the use of homeopathic teething products, after the medications were linked to hundreds of adverse events and 10 infant deaths. The agency also noted that the benefits purportedly associated with the use of the products are not based on any scientific evidence. Following that FDA warning, CVS and other retailers pulled homeopathic teething remedies from their store shelves.
Standard Homeopathic did announce it would no longer sell its teething tablets in the U.S., citing the “confusion” purportedly created by the first FDA warning. However, no recall was announced, and consumers were not offered any refunds. Last week, a company spokesperson told Reuters that it has declined to recall the products because it had already discontinued sales in October, and “did not see any additional action to be necessary.”
In November, Raritan Pharmaceuticals announced a voluntary recall of its homeopathic teething and ear pain remedies, after they were found to contain inconsistent levels of belladonna. Those products were not linked o any adverse events.
In 2010, a voluntary recall was issued for Hyland’s Teething Tablets, after they were tied to a number of adverse event reports consistent with belladonna toxicity.
Bernstein Liebhard LLP is evaluating teething tablets lawsuits involving seizures, deaths and other adverse events that may be linked to homeopathic remedies. To discuss a case with one of our attorneys, please call (888) 870-9331,