The U.S. Food and Drug Administration (FDA) issued an official warning last week urging parents to stop using homeopathic teething treatments due to a link between the remedies and life-threatening reactions in children.
According to an FDA press release, consumers are being warned to dispose of homeopathic teething tablets and gels which are distributed by CVS, Hylands, and possibly other retail outlets.
“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,” the announcement states.
“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, and promises 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 states.
Healthcare professionals and consumers are being urged to report adverse events or quality problems related to the use of homeopathic teething tablets or gels to the FDA’s MedWatch Adverse Event Reporting program.
Meanwhile, a spokesman for Hyland’s, maker of Hyland’s Baby Teething Tablets and Hyland’s Baby Teething Gel, told Daily Mail Online that they were surprised by the advisory and are wondering what grounds the agency has for issuing such a warning.
“We hope to learn from the FDA what facts, if any, it has based its action on,” Hyland’s said. “We remain confident that Hyland’s Baby Teething Tablets remain safe. Of course, parents who may have concerns should consult with their physicians before using any medicines, read labels carefully and follow all instructions.”
Hylands goes on to insist that the FDA tests homeopathic remedies; however the FDA clearly states that it does not do so.
According to the National Center for Complementary and Integrative Health, whose mission is to apply rigorous scientific investigation to the usefulness and safety of complementary and alternative treatments, has found no evidence to support the use of homeopathy, for teething or any other reason.
“Most rigorous clinical trials and systematic analyses of the research on homeopathy have concluded that there is little evidence to support homeopathy as an effective treatment for any specific condition.”