FDA Warns Against Homeopathic Teething Tablets, Gels

Ashley Hayes

October 07, 2016

Homeopathic teething tablets and gels, used by some parents to relieve teething pain and symptoms, may pose risks to infants and children, the FDA says.

The agency issued a warning late last month on the tablets and gels, which are sold in stores and online.

The FDA said it is investigating reports of side effects in children, including seizures in some, and is testing product samples. The agency previously issued a safety alert on the products in 2010, according to the statement.

However, one manufacturer of teething tablets, Hyland's, says it is "confident" its product is safe.

"We are fully cooperating with FDA's inquiry and we're providing them with all the data we have," Hyland's says in a statement posted on its website. "We also hope to learn from FDA what facts, if any, the agency has based its action on."

Homeopathic medicines are regulated as drugs by the FDA, but the agency notes in its warning that the products are not evaluated or approved by the FDA for safety or how well they work.

"The agency is also not aware of any proven health benefit of the products," the FDA says.

The warning advises parents to stop using the tablets and gels and dispose of them. They 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 tables or gels."

The FDA did not offer details on what might be causing the side effects.

Side effects or reactions can be reported to the FDA online.

Hyland's says its homeopathic medicines "are made in facilities that follow current good manufacturing practices and are inspected by the FDA in the same way as other OTC drugs are. You may use them with confidence."

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