Parents and caregivers of teething babies, take note: The U.S. Food and Drug Administration is warning against the use of homeopathic teething tablets and gels because they may be dangerous for infants and children. These products, sold by CVS, Hyland’s, and possibly other brands, are currently available in stores and online—but the FDA says not to buy them, and to dispose of any in your possession.
The warning comes as the FDA is investigating reports of seizures and other adverse effects in children given these products. The agency’s statement does not mention specific ingredients that parents should be on the lookout for, but says the agency is testing product samples and will continue to communicate with the public as more information is learned.
In 2010, the FDA issued a warning specifically about Hyland’s homeopathic teething tablets containing belladonna, an herb that can cause serious harm in large doses. Government lab tests had found that the tablets contained inconsistent amounts of belladonna, and the FDA had received reports of children taking more tablets than recommended.
At the time, Hyland’s manufacturer voluntarily pulled the tablets from the market. But the product was reintroduced, with a new formula (although still containing small amounts of belladonna), in 2011.
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Now, the FDA is urging parents to 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 any homeopathic tablet or gel. Doctors and consumers are also encouraged to report any health- or quality-related problems with the use of these products to the FDA’s MedWatch program.
Homeopathic remedies are made with ingredients from plants, minerals, and animals, diluted down to barely-there amounts. They are regulated by the FDA, but loosely: Unlike conventional medicines, they are not evaluated for safety or efficacy. In April 2015, however, the agency held public hearings on whether it should begin to treat homeopathic products the same way they do over-the-counter drugs. (Comments on the issue were accepted until November, but no update has been announced since.)
There is little scientific evidence that homeopathic remedies work, but Americans still spend billions of dollars on them every year.
In response to the FDA’s warning, CVS has voluntarily removed homeopathic teething products from shelves. Hyland’s Homeopathic issued a statement of its own. “We want you to know that we are confident that Hyland’s Baby Teething Tablets remain safe,” it read. “Of course, parents who may have concerns should consult with their physicians before using any medications, read labels carefully, and follow all instructions.”
Hyland’s also said that it is fully cooperating with the FDA’s inquiry, and hopes to learn what facts, if any, the agency has based its action on. In response to concerns about belladonna, the company said that only a “miniscule” amount—two trillionths of a milligram—is used per tablet. “A child would have to eat multiple bottles at once to experience the first side effect of belladonna, which is typically dry mouth,” the statement read.
The FDA, however, says it’s better to be safe than sorry.
“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, 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.”
In 2014, the FDA issued another statement about teething—this one warning against the use of the local anesthetic, viscous lidocaine, or of benzocaine-containing teething products. Although these products are marketed as gum-numbing, they can cause serious harm or even death when used on infants or young children.
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Rather than using any drug or homeopathic product, the FDA recommends massaging a child’s swollen or tender gums with your finger. Giving the child a cool teething ring or a cool, wet washcloth to chew on can help, as well.
“The cool object acts like a very mild local anesthetic,” FDA pediatrician Hari Cheryl Sachs, MD, said in the Agency's 2014 statement. “This is a great relief for children for a short time.”