The U.S. Food and Drug Administration is currently investigating a possible link between homeopathic teething tablets and gels and 400 adverse events and 10 child deaths, according to CNN.
On Sept. 30, the FDA announced it was investigating adverse events potentially related to the products. The events under review occurred after the FDA's initial warning about teething tablets in 2010. After the 2010 warning, Hyland's Homeopathic, the manufacturer of the teething tablets, issued a recall. At issue in the 2010 recall were inconsistent levels of belladonna detected in the tablets by the FDA and a number of adverse events reported in children indicative of belladonna toxicity.
Belladonna is a perennial herbaceous plant that can be toxic to humans if enough is consumed. The plant has been used for centuries as an herbal medicine to treat ailments like pain and the common cold, according to Medline Plus. Side effects of belladonna toxicity include fever, lethargy, vomiting, drowsiness, tremors, shortness of breath, irritability and agitation, according to CNN.
After the recall, Hyland reformulated the product to reduce the amount of belladonna, according to the company's website.
Since the FDA's most recent warning against teething tablets, Hyland issued a letter to parents stating it was discontinuing the distribution of its teething medicines in the United States.
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"This decision was made in light of the recent warning issued by the FDA against the use of homeopathic teething tablets and gels. This warning has created confusion among parents and limited access to the medicines," said Hyland in a letter signed by employees. "Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA."
Both Walgreens and CVS have pulled homeopathic teething products from their shelves. In a statement regarding the current investigation, the FDA said the relationship between the deaths and the teething products was unknown and currently under review, according to CNN.
"Teething can be managed without prescription or over-the-counter remedies," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research. "We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their healthcare professional for safe alternatives."
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