FDA Issues Warning for Belladonna in Hyland’s Homeopathic Teething Remedies
JANUARY 30, 2017: The U.S. Food & Drug Administration (FDA) has confirmed that Hyland’s homeopathic teething tablets contain inconsistent levels of belladonna which may far exceed the amount claimed on the label. In a statement issued on January 27, 2017 the agency advised consumers to stop using these products immediately and throw them away. While the FDA has asked the Standard Homeopathic Company to conduct a teething tablets recall for the Hyland’s products, it has not yet agreed to do so.
Homeopathic teething tablets and gels are marketed to relieve teething pain in infants and children. These products often contain belladonna, which in small amounts has a sedative effect. However, excessive levels of belladonna can be poisonous, resulting in seizures and other adverse events. Symptoms of belladonna toxicity include:
- Difficulty breathing
- Lethargy
- Excessive sleepiness
- Muscle weakness
- Skin flushing
- Constipation
- Difficulty urinating
- Agitation
This is not the first time Hyland’s products have been found to contain inconsistent amounts of belladonna. Hyland’s homeopathic teething remedies were recalled in 2010, after they were linked adverse events suggestive of belladonna poisoning.
The FDA initially warned against the use of homeopathic teething tablets and gels in September 2016, after such products were linked to hundreds of adverse events, including seizures. The agency was also aware of 10 infant deaths potentially associated with homeopathic teething remedies. While several retailers subsequently removed such products from their store shelves, Standard Homeopathic announced it would stop marketing Hyland’s teething tablets in the U.S. In November, Raritan Pharmaceuticals announced a recall of its homeopathic teething tablets and ear pain liquids after tests suggested they might contain varying amounts of belladonna. Thus far, the Raritan products have not been linked to any injuries.
NEWS PROVIDED BY Bernstein Liebhard LLP
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