Standard Homeopathic Company has issued a recall of its Hyland’s teething tablets for infants, the U.S. Food and Drug Administration (FDA) announced Thursday.
Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets are now being removed from store shelves after the FDA found the products contained amounts of belladonna alkaloids inconsistent with those presented on the labels.
The FDA believes that the two products, which were linked to 10 infant deaths, pose a “serious health hazard to children” due to the unpredictability of belladonna.
“There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it,” the agency told Standard Homeopathic Company in the announcement.
Belladonna has long been used for homeopathic remedies. Although the plant, nicknamed the deadly nightshade, is known for its medicinal properties, it can have toxic effects if taken in large doses.
Dr. Natasha Burgert, a Kansas City-based pediatrician, told CNN that belladonna can be harmful but “my suspicion is that, when using it in teething tablets at homeopathic doses, the likelihood of a significant reaction is likely low.”
“However, I think it is appropriate for the FDA to be concerned that these homeopathic tablets and regimens are not regulated,” she added.
Although Standard Homeopathic Company declined to officially recall the products last fall, it did stop making and shipping the remedies in October 2016. The April 13 recall ensures that any products on the shelves are removed.
“We initiated this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested,” chairman and CEO of Standard Homeopathic Company J.P. Borneman said in the release.
“We are committed to maintaining and earning the trust consumers have placed in Standard Homeopathic Company,” he added. “We have worked for 114 years to build relationships with our consumers. We intend to preserve that tradition of trust.”
Hyland’s Issues Known Since Last Fall
Even though Standard Homeopathic Company initiated a recall last week, the FDA requested a recall of the products in January when the agency confirmed elevated levels of belladonna in the teething tablets. The company denied the request.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a Jan. 27 news release. ”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.”
This additional warning came on the heels of a strong warning issued by the FDA in September 2016, which said that homeopathic teething remedies could pose a risk to infants and children. The agency specifically cited Hyland’s, CVS and other brands.
Since 2010, the FDA has received hundreds of reports of adverse effects, such as seizures, difficulty breathing, lethargy, muscle weakness, constipation, difficulty urinating and more.
Last year, the agency was aware of 10 deaths that were linked to homeopathic teething products but could not say they were the definitive cause. The Arizona Republic confirmed that the FDA continues to believe the 10 deaths were associated with the products but did not have details on the investigation.
Hyland’s Continues to Support Products
After the warnings from September 2016, Hyland’s products were discontinued, but the company continued to stand by its products.
“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.”
After the recent recall, Hyland’s issued a news release to the public on its website and reaffirmed that the products were tested for safety.
“It is important for you to know that all manufactured and sold teething medicines met the Company’s safety limit tests and all tested product has been well within an established safety threshold,” the website says. “With this recall, Hyland’s is adhering to what its regulating agency has formally requested.”
Those who have experienced adverse effects after using the products are encouraged to seek medical attention and report any problems to the FDA’s MedWatch Adverse Event Reporting program.