The U.S. Food & Drug Administration (FDA) has cautioned parents and caregivers to steer clear of using homeopathic teething gels and pills to relieve teething pain in their little ones. According to an alert issued on Friday, September 30th, the agency is investigating reports of seizures that have occurred in infants and children treated with the products.
Homeopathic teething gels and tablets are sold under several brand names, including Hyland’s, Baby Orajel Naturals and others. The products are available at CVS and other retail stores, as well as various via online outlets. According to the FDA, these products have not been evaluated or approved by the agency for safety or efficacy. What’s more, they’ve never been proven to offer any actual health benefits.
“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.”
Parents and caregivers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation following treatment with homeopathic teething tablets or gels.
In 2010, the FDA issued a Consumer Safety Alert for Hyland’s Teething Tablets, after those homeopathic products were found to contain belladonna, a substance that can cause serious harm at larger doses. At the time, the agency disclosed that the Hyland’s tablets had been implicated in a number of adverse event reports involving children who had symptoms consistent with belladonna toxicity. The FDA noted that the bottles containing Hyland’s Teething Tablets lacked a child-proof cap, while laboratory testing indicated the tablets contained inconsistent amounts of belladonna. Because of these issues, the manufacturer agreed to issue a recall for the product.
This most recent alert has now prompted CVS to announce a voluntary recall of homeopathic teething gels and tablets sold at its retail stores. Affected products include:
In a statement, CVS said it was in the process of removing the recalled products from its stores. A “do not sell” block has been placed in the store register system to prevent further sale of any affected items.