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    • FDA warns against the...

    FDA warns against the use of homeopathic teething tablets and gels

    Written by savita thakur thakur Published On 2016-10-01T14:29:43+05:30  |  Updated On 1 Oct 2016 2:29 PM IST
    FDA warns against the use of homeopathic teething tablets and gels

    The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.


    Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.


    Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.


    “Teething can be managed without prescription or over the counter remedies,” said Janet Woodcock, M.D., 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.”


    The FDA is analyzing adverse events reported to the agency 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, including testing product samples. The agency will continue to communicate with the public as more information is available.


    Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.


    The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA’s Med Watch Adverse Event Reporting program:




    • Complete and submit the report online at www.fda.gov/medwatch/report.htm; or

    • Download and complete the form, then submit it via fax at 1-800-FDA-0178.


    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

    Dr Janet WoodcockFDA’s Center for Drug Evaluation and Researchhomeopathic teethinghomeopathic teething tabletsUS Department of Health and Human ServicesUS Food & Drug AdministrationUSFDA
    Source : FDA

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    savita thakur thakur
    savita thakur thakur
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