FDA issues alert on homeopathic teething tablets, gels

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SILVER SPRING, Md. — The Food and Drug Administration has issued a warning that homeopathic teething tablets and gels may present a health risk to infants and children.

The FDA on Friday urged consumers to stop using the products and dispose of any that they have. The agency said the homeopathic teething tablets and gels are sold and retail stores and online, and they include products distributed by CVS and Hyland’s, as well as potentially other products.

Woodcock_Janet_FDA_CDER

Janet Woodcock

According to the FDA, 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.

“Teething can be managed without prescription or over-the-counter remedies,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said 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.”

CVS said late Friday that it’s voluntarily withdrawing all brands of homeopathic teething products sold in its retail stores and at CVS.com.

The drug chain said the affected items include CVS Homeopathic Infant’s Teething Tablet 135-count, CVS Homeopathic Infant’s Teething Liquid 0.85-oz., Hyland’s Baby Nighttime Teething Tablets 135-count, Hyland’s Baby Teething Gel 0.5-oz., Hyland’s Baby Teething Tablets 13-count, Hyland’s Baby Teething Tablets 135-count and Hyland’s Teething Gel 0.33-oz., as well as Church & Dwight Inc.’s Baby Orajel Naturals Gel for Teething Pain 0.33-oz., Baby Orajel Naturals Gel for Teething Pain Nighttime Formula 0.33-oz. and Baby Orajel Naturals Tablets for Teething Pain 125-count.

CVS added that it has placed a “do not sell” block in its store register system to prevent further sales of any affected items.

On Friday, Hyland’s Inc. reaffirmed the safety of its homeopathic teething tablets and gels in response to the FDA warning.

“As you may have seen, on Sept. 30, 2016, the Food and Drug Administration issued a surprise statement recommending that consumers discontinue use of homeopathic teething tablets and gels because they may pose a risk. We want you to know that we are 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,” Hyland’s said in a statement. “Homeopathic medicines are regulated as drugs by FDA. We are fully cooperating with FDA’s inquiry, and we’re providing them with all the data we have. We also hope to learn from FDA what facts, if any, the agency has based its action on.”

The FDA noted that it hasn’t evaluated or approved homeopathic teething tablets and gels for safety or effectiveness, and that the agency isn’t aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.

In addition, the FDA said it’s currently investigating the issue, including testing homeopathic teething tablet and gel product samples. The agency said it’s also analyzing reports of adverse events that it has received 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.


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