We previously reported that the FDA had warned parents against using homeopathic teething products. In September 2016, the FDA announced that it was conducting an investigation into the products in response to more than 400 adverse event reports over the past six years, including 10 reported deaths.
Now, the FDA says that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amounts claimed on the product’s label. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said “[t]he body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk.” The FDA again warned parents not to purchase belladonna-containing teething tablets and to dispose of any in their possession.
Standard Homeopathic Company has not agreed to conduct a recall of its Hyland’s homeopathic teething products. However, according to the company’s website, the product is no longer being distributed in the United States.
For more information on this subject, contact Melissa Prickett or Liz Eiland, lawyers in our firm’s Mass Torts Section, at 800-898-2034 or Melissa.Prickett@beasleyallen.com or Liz.Eiland@beasleyallen.com.
Sources: Law360.com, FDA.gov and Hyland.com
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