The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children.
The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products.
Problems reported to the FDA regarding the homeopathic products include: seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.
Consumers should obviously seek medical care immediately if their child experiences any of the above issues. The FDA is currently investigating these reports , including testing product samples. The agency will continue to communicate with the public as more information is available.
Homeopathic teething tablets and gels are primarily distributed by drugstores and health food stores, and are also sold online.
CVS Pharmacy announced today that it has voluntarily withdrawn all brands of homeopathic teething products sold in its retail stores and online at CVS.com. The voluntary withdrawal is being conducted in light of the FDA’s announcement today recommending that consumers stop using these products.
The products being removed from CVS include:
- Baby Orajel Naturals Gel for Teething Pain, .33 oz
- Baby Orajel Naturals Gel for Teething Pain Nighttime Formula, .33 oz
- Baby Orajel Naturals Tablets for Teething Pain, 125 Count
- CVS Homeopathic Infant’s Teething Tablet, 135 Count
- CVS Homeopathic Infants’ Teething Liquid, .85 oz
- Hyland’s Baby Nighttime Teething Tablets, 135 Count
- Hyland’s Baby Teething Gel, .5 oz
- Hyland’s Baby Teething Tablets, 13 Count
- Hyland’s Baby Teething Tablets, 135 Count
- Hyland’s Teething Gel, .33 oz
The FDA recommends that consumers stop using these products and dispose of any in their possession.
“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”
Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.
In 2010, the FDA issued an advisory for a specific brand of homeopathic teething tablets sold by Hyland’s, a well-known retailer of homeopathic remedies. The advisory focused on the product’s inclusion of belladonna as an active ingredient, a plant that has been used as muscle relaxant but which can be toxic and even deadly in high enough doses. The difference between an effective dose of Belladona and a toxic dose is very slim.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA’s MedWatch Adverse Event Reporting program:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.