Homeopathic teething tablets and gels may pose a risk to infants and children: FDA
Homeopathic teething tablets and gels have not been evaluated or approved, U.S. agency says
The U.S. Food and Drug Administration is calling for parents to steer clear of homeopathic teething products because of potential risks.
Homeopathic teething tablets and gels are sold at pharmacy retailers and online.
The regulator says 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, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a release on Friday.
The regulator is analyzing adverse events reported to the agency associated with homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about the products.
At the time, Hyland's Homeopathic Canada voluntarily recalled Hyland's Teething Tablets because they could harm infants and toddlers, according to tests done by the FDA.
The FDA said homeopathic teething tablets and gels have not been evaluated or approved by the agency for safety or efficacy.
The products are labelled to relieve teething symptoms in children.
Hyland's, Inc., a division of Standard Homeopathic Co., said it is confident the Hyland's Baby Teething Tablets remain safe. The company is cooperating with the FDA's inquiry.