The FDA has reiterated its caution to parents regarding the use of homeopathic teething products for infants, specifically those made by Hyland’s. While the company has opted to cease production of their teething tablets and gels, they have not issued a formal recall.
Many parents, including myself and my colleagues, relied on Hyland’s Teething Tablets in the past when our babies exhibited signs of teething—crying, drooling, and gnawing on their gums. The belief that these natural remedies were safer than pharmaceuticals led us to believe they posed no risk. However, recent insights from the FDA highlight a troubling reality surrounding these products.
History of Concerns
The FDA first flagged Hyland’s in 2010 following a voluntary recall prompted by concerns over the presence of belladonna, a toxic substance. Laboratory tests revealed that the tablets contained varying amounts of this ingredient, raising alarm about their potential danger. Reports of adverse effects began surfacing as early as 2006, growing in number over the years to include serious incidents such as seizures, loss of consciousness, and—tragically—deaths. One parent shared a heartbreaking account of their child who passed away after using the product.
Recent FDA Statements
As of last September, the FDA issued a statement warning that these homeopathic teething tablets and gels could pose significant risks to young children. The agency emphasized that immediate medical attention should be sought if any concerning symptoms arise after use, including seizures or difficulty breathing. Even after the FDA’s warning, Hyland’s maintained that their products were safe, despite their decision to withdraw them from retail shelves.
Adverse Events and Regulatory Gaps
Between 2010 and 2016, the FDA documented an alarming 370 adverse events linked to Hyland’s products, including eight fatalities, although the agency is still assessing if these incidents were directly caused by the teething tablets. Because homeopathic remedies are not required to demonstrate efficacy before hitting the market, the FDA does not evaluate their safety or effectiveness. This regulatory gap leaves parents vulnerable and confused, especially after numerous complaints from those whose children suffered adverse reactions.
Current Recommendations
On January 27 of this year, the FDA reiterated its warning about the unpredictable levels of belladonna found in some of Hyland’s teething products, urging consumers to refrain from using them. Even though Hyland’s has ceased manufacturing these items, they have not enacted a recall, citing confidence in their product safety based on their own data.
Staying Informed
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Conclusion
In conclusion, the FDA’s ongoing warnings about the dangers of homeopathic teething products must not be taken lightly. Parents should be vigilant and choose safer alternatives for their children’s teething discomfort.