FDA Issues Warning on Homeopathic Teething Remedies

In a recent press release, the United States Food and Drug Administration (FDA) has warned consumers to stop using homeopathic teething tablets and gels because they might cause harm to infants and children. According to the FDA, homeopathic teething products have not been evaluated by the agency and are not approved for use based on their safety or efficacy. The FDA is currently not aware of any proven health benefit these types of products provide.

The FDA also warns parents to seek immediate medical attention for their child if the child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using any homeopathic products.

Currently, the agency is analyzing reports of adverse events submitted to the FDA since a 2010 safety alert was issued regarding homeopathic teething tablets. Some of the reports submitted to the FDA since the initial safety alert include information about seizures in infants and children who were given homeopathic products. The FDA is currently testing product samples and will provide further information about the results of such testing, and any other relevant information, as more information becomes available.

Homeopathic teething tablets and gels are touted as a natural solution providing fast and effective pain relief due to teething. They are designed to be used temporarily to relieve restlessness, irritability, and gingiva redness in children. These products are distributed in several locations, including CVS, Hyland’s, Amazon, and others.

According to Janet Woodcock, M.D. and Director of the FDA’s Center for Drug Evaluation and Research, “Teething can be managed without prescription or over-the-counter remedies. 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 advises consumers to dispose of these products immediately. Also, both consumers and healthcare providers are encouraged to report any adverse events or other problems experienced by children after the use of any homeopathic teething tablets or gels. Reports can be made through the FDA’s Medwatch Adverse Event Reporting system, either online or by fax.

The FDA is responsible for regulating the safety and security of America’s food supply, cosmetics, dietary supplements, tobacco products, and any products that give off electronic radiation. The agency also provides for the public’s safety through regulation of human and veterinary medications, vaccines, other biological products, and medical devices.