FDA Issues Safety Alert for Homeopathic Teething Products

The U.S. Food and Drug Administration is warning the public that homeopathic tablets and gels aimed at alleviating discomfort for teething infants may have adverse side effects, including seizures.

Homeopathy is an alternative system of medicine involving natural substances. It has long been a subject of controversy. Many studies have failed to find evidence that these homeopathic remedies actually work any better than placebos.

But now, a recent FDA communication released Friday cautions that homeopathic teething tablets and gels may actually be harmful to babies and recommends not using them.

The FDA goes so far as to strongly urge consumers to “dispose of any in their possession.”

In the press release, the FDA said that it’s “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 agency goes on to state they are currently investigating and testing product samples and “will continue to communicate with the public as more information is available.”

Possible complications to be aware of when using these homeopathic teething tablets and gels are “seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation” and any of the above should result in seeking medical care, the FDA cautions.

Homeopathic remedies aren’t evaluated for safety and effectiveness by the FDA. The agency wrote that it is “not aware of any proven health benefits” of the teething tablets and gels.

It has, however, been concerned about homeopathic teething tablets and gels since 2010, when the agency issued a safety alert about Hyland’s Teething Tablets, which contained inconsistent amounts of belladonna (also known as deadly nightshade, which can be potentially harmful toxic in large doses).

Hyland’s tablets are intended to provide relief from the pain, sleeplessness and irritability that babies can experience while teething. The company has assured consumers its homeopathic teething tablets are safe but is cooperating with the FDA.

“We have seen rumors that circulate regarding the safety of belladonna – an active ingredient in Hyland’s Baby Teething Tablets – and we know that these warnings can cause fear and worry,” Hyland’s noted. “This new FDA statement increases the confusion. The safety and effectiveness of Hyland’s natural homeopathic medicines is our top priority. That’s why we work with regulators to ensure that our products meet the highest standards. If we ever had reason to be concerned of that safety, we would act immediately.”

According to Hyland’s, the amount of belladonna used in its Hyland’s Baby Teething Tablets is minuscule with only two trillionths of a milligram per tablet. A child would have to consume multiple bottles at once to experience the first side effect of belladonna, which is typically dry mouth.

The FDA statement named both CVS Pharmacy and Hyland’s in its warning: “Homeopathic teething tablets and gels are distributed by CVS, Hyland’s and possibly others, and are sold in retail stores and online.”

Following the FDA announcement, CVS Pharmacy voluntarily withdrew all homeopathic teething products, including Hyland’s, Orajel and several CVS brand products.

And as Janet Woodcock M.D., the director of the FDA’s Center for Drug Evaluation and Research, said in the news alert, “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 agency is asking parents and medical professionals to report any adverse events or problems related to homeopathic teething products to the agency’s MedWatch Adverse Event Reporting Program.