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Hyland's responds to FDA teething tablet warning


LOS ANGELES - Hyland's issued a video and statement in response to a Food and Drug Administration warning against the use of homeopathic teething remedies issued Friday, assuring consumers that Hyland's Baby Teething Tablets remain safe.

"As you may have seen, on September 30, 2016, the Food and Drug Administration issued a surprise statement recommending that consumers discontinue use of homeopathic teething tablets and gels because they may pose a risk," Hyland's stated. "We are fully cooperating with FDA’s inquiry and we’re providing them with all the data we have. We also hope to learn from FDA what facts, if any, the Agency has based its action on."

The FDA reported the agency is analyzing adverse events regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, the agency stated, including testing product samples.

“Teething can be managed without prescription or over-the-counter remedies,” stated Janet Woodcock, 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 health care professional for safe alternatives.”

"We have seen rumors that circulate regarding the safety of belladonna – an active ingredient in Hyland’s Baby Teething Tablets – and we know that these warnings can cause fear and worry," Hyland's noted. "This new FDA statement increases the confusion. The safety and effectiveness of Hyland’s natural homeopathic medicines is our top priority. That’s why we work with regulators to ensure that our products meet the highest standards. If we ever had reason to be concerned of that safety, we would act immediately."

 According to Hyland's, the amount of Belladonna used in Hyland’s Baby Teething Tablets is miniscule with only two trillionths of a milligram in a tablet. A child would have to eat multiple bottles at once to experience the first side effect of belladonna, which is typically dry mouth.

The statement named both CVS Pharmacy and Hyland's in its warning: "Homeopathic teething tablets and gels are distributed by CVS, Hyland’s and possibly others, and are sold in retail stores and online." Following the announcement, CVS Pharmacy pulled the products in question off its shelves. "The voluntary withdrawal is being conducted in light of the FDA's announcement today recommending that consumers stop using these products," CVS Health stated.



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