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FDA: Adverse events linked to teething tablets still under investigation


NEW YORK - The Food and Drug Administration on Thursday confirmed that while more than 400 reports of adverse events have been associated with homeopathic teething products in the past six years, the agency is still investigating that association.

"We are also aware of reports of 10 deaths during that time period that reference homeopathic teething products," Lyndsay Meyer, FDA press officer, shared in an email to Drug Store News. "Though the relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review."

"At this time, the FDA is still conducting our investigation, and we have not yet completed the analyses of products to determine if there is an association between the adverse events and the homeopathic teething products," Meyer added.

While that review is ongoing, CVS Health last week announced it would withdraw all homeopathic teething products off its shelves, including both Hyland's and Church & Dwight's Orajel Naturals as well as the company's store brand offering. Likewise, Hyland's last week decided to cease distribution of its teething products in the U.S. market, though the company maintained its products are safe.

"Over the course of the last six years, Hyland’s has developed and now employs state-of-the-art safety and testing procedures to ensure all its baby products are safe for our youngest users," Hyland's noted in a statement released Wednesday. "Data from that program continues to indicate our products are safe. We look forward to working in partnership with the FDA to continue providing safe and effective medicines to families around the world."

The decision to stop selling teething tablets in the U.S. did not come lightly, the company noted in an open letter posted on the company's web site earlier this week. "It is ... with much sadness that we share with you that we have chosen to discontinue the distribution of our Hyland’s teething medicines in the United States. This decision was made in light of the recent warning issued by the Food & Drug Administration against the use of homeopathic teething tablets and gels. This warning has created confusion among parents and limited access to the medicines," Hyland's stated. "Our first commitment is to you, the parents who trust us every day with the wellbeing of your families."

Hyland's noted that many retailers have chosen to stop selling homeopathic teething medicines in their stores while others have not. "We are confident that any available Hyland’s teething products, including those you already have, are safe for use," Hyland's noted. "Of course, parents who may have concerns should consult with their physicians before using any medicines, read labels carefully and follow all instructions."


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