The Food and Drug Administration urged parents Friday to not use Hyland’s homeopathic teething products containing belladonna, commonly known as deadly nightshade — a toxic substance.
Standard Homeopathic Co., the Los Angeles-based maker of Hyland’s, discontinued its product October 7.
“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,” said Mary C. Borneman, a spokeswoman for Hyland’s.
Homeopathic teething tablets, which have been around since the early 1900s, provide temporary relief to babies growing their first teeth.
The FDA originally issued a safety alert in 2010 that recommended against Hyland’s Teething Tablets based on laboratory results showing that they contained inconsistent amounts of belladonna. Since then, the agency has received more than 400 reports of adverse events linked to teething products that contain belladonna.
“Most describe serious adverse events, like seizures,” said Lyndsay Meyer, a spokeswoman for the FDA. “We are also aware of reports of 10 deaths during that time period that reference homeopathic teething products.”
Whether these deaths directly relate to teething products “has not yet been determined and is currently under review,” Meyer added.
The FDA issued a second belladonna warning in September. Though Hyland’s discontinued the product in October, it continued to affirm the safety on its website.
“Our understanding is that the Food and Drug Administration’s investigation of these products is still ongoing,” says the company’s news release issued at that time. “The fact is that we have not been made aware of any medical or statistical evidence to support a causal link between homeopathic teething tablets and adverse outcomes at this point. We continue to request any available information and statistics from the FDA.”
The FDA announcement Friday confirms its original laboratory assessment of inconsistent amounts of belladonna.
“They showed some limited data on samples they tested that indicated inconsistent amounts of belladonna alkaloid at the nanogram level,” Borneman said. However, the results “remained within the documented margin of safety.”
“The implication in the FDA release is that consumers who still have the product shouldn’t use it because it might be unsafe,” she said.
The FDA release noted that Raritan Pharmaceuticals, based in New Jersey, recalled three of its belladonna-containing homeopathic products in November, yet Hyland’s had not issued a recall.
“They never actually asked us to recall it, nor did we ever actually refuse to recall it,” Borneman said. “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.”
Typically, labels claim that homeopathic teething products contain “natural ingredients,” such as chamomile, a daisy-like plant recommended by midwivees for calming babies with colic, and calcarea carbonica, which is made from shells and is, essentially, an impure version of calcium carbonate an ingredient used in antacids.
Some also include belladonna.
“Since the body’s response to belladonna in children under 2 years of age is unpredictable, using such products places them at unnecessary risk,” Meyer said. Therefore, the FDA recommends that parents stop giving babies any product that contains belladonna “and dispose of any in their possession.”
Instead of teething gels or tablets, the American Academy of Pediatrics recommends gently rubbing or massaging the child’s gums with your finger and giving the child a cool (not cold) teething ring or a clean, wet, cool washcloth to chew on.
Though they’re discontinued, Borneman stands by the safety of Hyland’s Teething Tablets: “They are a top-selling product and a consumer favorite, and sadly it resulted in the loss of 24 jobs.”