When a child is in pain from teething, most parents will do everything they can to ease the pain. But what may seem like safe homeopathic teething treatments you can buy at the local drugstore may actually contain dangerous levels of a toxic chemical.
The U.S. Food and Drug Administration (FDA) issued a warning Jan. 27 that confirmed its laboratory found varying amounts of the substance belladonna in certain Hyland’s teething products. The agency is urging consumers that teething tablets and gels containing belladonna pose an unnecessary risk to infants and children.
Belladonna, also known as deadly nightshade, is a substance regularly found in different types of homeopathic treatments. However, the ingredient may be harmful to children.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”
After the FDA analysis found that the amount of belladonna in the products sometimes “far exceeded” the amount claimed on the label, the agency reached out to the manufacturer of Hyland’s homeopathic teething products regarding a recall. The Los Angeles-based Standard Homeopathic Company has not yet agreed to conduct a recall.
The FDA currently recommends that consumers immediately stop using the belladonna-containing products marketing by Hyland’s and dispose any in their possession. The agency encourages parents to find other ways to treat teething discomfort.
“Teething can be managed without prescription or over-the-counter remedies,” said Woodcock in September. “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 Products Subject of FDA Attention
This announcement from the FDA is in line with previous warnings about homeopathic treatments for teething. These teething products have not been evaluated or approved by the FDA for safety or effectiveness, and the agency has yet to find any proven health benefits of the products.
Homeopathic teething products by Raritan Pharmaceuticals were also a recent target of the regulatory agency. In November, the company issued a voluntary recall on several products with inconsistent levels of belladonna extract.
The affected products — CVS Homeopathic Infants’ Teething Tablets, Kids Relief Homeopathic Ear Relief Oral Liquid and CVS Homeopathic Kids’ Ear Relief Liquid — were distributed nationwide. The FDA encouraged consumers to stop using the products immediately and contact Raritan Pharmaceuticals for a refund.
That recall came just two months after the FDA warned consumers not to use homeopathic teething tablets and gels on their children because of reported side effects that included difficult breathing, seizures, lethargy and more.
The FDA is also investigating 10 reports of deaths that may be connected to homeopathic teething products, though no definitive link has yet been made.
Shortly after the FDA issued its September warning, Hyland’s discontinued the products but continued to tout their safety.
“Neither we nor FDA have recalled the homeopathic teething tablets or gels,” Hyland’s said on its website in October. “While we are confident that Hyland’s Baby Teething Tablets and Teething Gel remain safe for use, it is up to you to make the decision about the medicines you administer to your child to relieve symptoms of teething.”
Although the latest laboratory results from the agency suggest evidence of inconsistent amounts, a spokesperson for Hyland’s responded to those claims.
“They showed some limited data on samples they tested that indicated inconsistent amounts of belladonna alkaloid at the nanogram level,” Mary C. Borneman told CNN. She went on to say the results “remained within the documented margin of safety.”
Hyland’s Faces Lawsuits Over Teething Products
Hyland’s is no stranger to controversy regarding its homeopathic teething products. In 2010, the FDA issued a similar warning that Hyland’s Teething Tablets may pose a risk to children due to variations in the amount of belladonna present. At that time, Hyland’s recalled the product and later reintroduced it in 2011 after reworking the formula.
Late last year, three women filed a class-action lawsuit against five companies that make and sell homeopathic teething gels and tablets. The Nov. 9 complaint says the defendants, which includes Hyland’s, manufactured or sold products that are ineffective and unsafe for children.
The case is currently making its way to the courts and more lawsuits are expected.