The US Food and Drug Administration (FDA) is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA is analyzing adverse events reported to the agency since a 2010 safety alert regarding these products, including seizures in infants and children who were given them.
The agency is now testing product samples and will continue to communicate with the public as more information becomes available. The FDA has not evaluated or approved these tablets or gels for safety or efficacy, nor is it aware of any proven health benefit they provide, though they are labeled to relieve teething symptoms in children.
These products are sold in retail stores and online. The FDA recommends that consumers stop using them and dispose of any in their possession. Also, the FDA 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 them.
Healthcare professionals and patients are encouraged to report adverse effects or side effects related to the use of homeopathic teething tablets and gels to the FDA’s MedWatch Safety and Adverse Even Reporting Program at fda.gov/medwatch/report. Those who want to report these effects also can download a form online or request one by calling (800) 332-1088.
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