Teething tablets, used to temporarily relieve the symptoms of simple restlessness and wakeful discomfort due to cutting teeth (teething) discomfort, may be linked to the deaths of 10 children, reports say. According to the U.S. Food and Drug Administration nearly a dozen children who used homeopathic teething tablets in addition to 400 adverse events associated with the popular tablets and gels have been reported to the FDA.
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On Wednesday, Oct. 12, the agency issued a warning to consumers that homeopathic teething tablets and gels, distributed by retail stores like CVS and Hyland’s, as well as online, may pose a risk to infants and young children. In light on the new findings, the FDA recommends that consumers stop using these products and dispose of any in their possession.
In the event your child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels, they should seek emergency treatment immediately.
“Teething can be managed without prescription or over-the-counter remedies,” Director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, M.D., said in a statement. “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.”
Meanwhile, in an email statement, Hyland’s, a maker of homeopathic teething tablets and gel, said, “Hyland’s has not been made aware of any data that supports the claims in the warning against our teething tablets and gels. Our understanding is that the Food and Drug Administration’s investigation of these products is still ongoing. The fact is that we have not been made aware of any medical or statistical evidence to support a causal link between homeopathic teething tablets and adverse outcomes at this point. We continue to request any available information and statistics from the FDA,” reports CNN.
“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 employees said in a separate statement posted on its website, on Tuesday, Oct. 12. “Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA.”
In the meantime, the FDA revealed they’re analyzing the adverse events connected to homeopathic teething tablets and gels, including testing product samples, as neither has been evaluated or approved by the FDA for safety or efficacy. Furthermore, the agency is encouraging health care professionals and consumers to report undesirable reactions or quality problems associated with the use of said products to the FDA’s MedWatch 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.
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