The U.S. Food and Drug Administration (FDA) warned last month of reports of 10 deaths associated with homeopathic teething products for babies. However, the exact relationship of these products to those infant deaths has yet to be determined. The FDA said that it had begun investigating the teething gels and tablets – which are labeled to prevent teething pain – in September, after receiving a report that a child had a seizure after being administered a homeopathic teething product. On further examination, the FDA said, there were more than 400 reports of adverse events in the past six years – including death, seizure and fevers – related to homeopathic teething products.
The FDA first warned parents to stop using the tablets and gels on Sept. 30 and urged them to seek immediate medical care if their child has seizures, trouble breathing or muscle weakness after using the products. The agency stated on Oct. 10:
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.
Also on the same day, homeopathic remedy maker Hyland’s Inc. said in a notice on its website that it was voluntarily stopping distribution of the company’s teething products in the U.S. in light of the FDA’s warning. CVS Health Corp. also voluntarily pulled all homeopathic teething products from its shelves after the September warning, the FDA said.
The regulator said that its preliminary review shows that these adverse events are similar to those seen in 2010, when the agency warned of belladonna toxicity associated with Hyland’s teething tablets. The FDA also emphasized that while adverse event reports give some information about a product and serious injuries or deaths related to its use, the reports also often indicate situations needing more analysis and do not constitute conclusive evidence of a problem with the product. The FDA said:
Sometimes after further analysis, the adverse events may inform agency decisions to take regulatory action. Other times, further analysis shows that the adverse events were not attributable to a problem with the product but to other factors, such as a patient’s underlying health conditions.
In its September warning, the FDA had said that homeopathic teething tablets and gels have not been evaluated or approved by the agency for safety or efficacy. The agency also said that it was unaware of any proven health benefit of the products. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement:
Teething can be managed without prescription or over-the-counter remedies. 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.
Lawyers in our Mass Torts Section will continue to monitor developments in this matter. For more information on this subject, contact Mellisa Prickett at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com or 800-898-2034.
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