The FDA announced on Jan. 27 that its lab analysis found inconsistent amounts of belladonna in certain homeopathic teething tablets. In some cases, the amount on the label was exceeded significantly, posing unnecessary risks for infants and children.
Homeopathic teething tablets, which have been produced since the 1900s, are products used for the temporary relief of teething symptoms in children. Inconsistent levels of belladonna can cause a series of reactions such as seizures, excessive sleepiness, muscle weakness, and skin flushing in children.
Belladonna Content In Hyland's Homeopathic Teething Tablets
The FDA asked Los-Angeles based Standard Homeopathic Company, the manufacturer of Hyland's teething products, to recall the products from the market. However, the company has not agreed to do so.
"They never actually asked us to recall it, nor did we ever actually refuse to recall it. We're a 114-year-old company. Families are the core of what we do. If we really thought there were any safety issues, we would definitely take the next step," noted Mary C. Borneman, Hyland's spokeswoman.
The original safety alert was issued by the FDA back in 2010, recommending against Hyland's Teething Tablets due to lab results suggesting they had inconsistent amounts of belladonna. Since then, more than 400 reports on adverse effects linked to teething products containing belladonna have been issued.
"We discontinued it because we are committed to our moms and our dads who choose to trust us to put medicines in their young infants' mouths, and we didn't want to put them in a place between the FDA warning and us saying the product was safe and having to decide who to trust," Borneman added.
Homeopathic teething products haven't been approved or evaluated by the FDA for either safety or effectiveness. The agency does not know of any proven health benefit of the products, and back in September 2016 warned against the use of the products because of the number of adverse reports.
"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," noted Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
After the warning in September, the company discontinued the product in October 2016, but continued to affirm its safety on the website.
Generally, labels claim that homeopathic teething products contain natural ingredients, ranging from daisy-like plants to chamomile, but some also include belladonna.
Teething Pain Recommendations
At the same time, the American Academy of Pediatrics recommends that parents should only massage their children's gums with their fingers, and give the kids a cool teething ring. It shouldn't be frozen, however. Parents shouldn't try powerful medication on their children, either.
"The American Academy of Pediatrics does not recommend putting any prescription or over-the-counter pain relievers and medication that contain lidocaine or benzocaine on babies' gums. These products are not useful for teething pain because they wash out from the baby's mouth in minutes. Instead, the caregivers can give babies a teething ring that has been chilled in the refrigerator, which will dull the pain. Frozen teething rings are not recommended because they can be too hard on gums. Caregivers also can gently rub or massage the child's gums," said a study published in the AAP News & Journals Gateway.