Hyland Inc. has finally given in to pressure from the Food and Drug Administration (FDA) and recalled two of its teething tablet products.
On its website, the company issued a statement, saying it had made the "very difficult decision" to pull from store shelves its Baby Teething Tablets and its Nighttime Baby Teething Tablets.
Company officials said no other Hyland products are affected.
The company said it believes the two recalled products are safe, but Hyland is "adhering" to what the FDA has requested.
On April. 7, FDA officials issued a strongly worded letter tellling Hyland to issue an immediate recall of the two products.
In October, FDA officials released an advisory recommending parents not give their children homeopathic teething tablets or gels.
The tablets and gels are sold online as well as in some stores.
Hyland’s, which says it has the best-selling brand of teething tablets, told CNN at the timie that it stands by its product.
CVS pharmacies, however, announced they had pulled from its shelves the Hyland’s products as well as their own versions and those made by Baby Orajel Naturals.
The FDA recommended parents stop using these products and throw away any they have in their home.
“Teething can be managed without prescription or over-the-counter remedies,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release.
The advisory was made after parents reported their children were experiencing seizures, having difficulty breathing, and displaying lethargy, among other symptoms, after taking the homeopathic products.
FDA officials said they are investigating the incidents. They added the homeopathic tablets and gels have not been evaluated for safety or efficacy.
This is not the first advisory the FDA has made against homeopathic teething tablets. In 2010, the FDA released another advisory. This one specifically named the brand Hyland’s.
Teething tablets are meant to treat the symptoms that babies experience when their first sets of teeth come in.
Homeopathic tablets contain diluted versions of natural substances.
Hyland’s teething tablets contain belladonna.
Belladonna is a nightshade plant. It’s been used to treat tremors and spasms — symptoms caused by conditions such as colitis and Parkinson’s disease.
However, belladonna also has the potential to be dangerous.
Dr. David Krol, the chair of the American Academy of Pediatrics (AAP) Section on Oral Health, says “There isn’t really a use for it in children and … it can have significant side effects.”
Research shows that children can overdose on belladonna after ingesting the equivalent of only two or three of the berries. This makes it important that dosage is monitored carefully.
The 2010 FDA advisory stated that Hyland’s tablets did not have a consistent amount of belladonna in each tablet. This made it more likely that infants would overdose on the tablets.
The company issued a recall and a new tablet was introduced in 2011.
The difficulty with soothing a baby’s symptoms while they’re teething is that there isn’t much research to support what does and doesn’t work.
In fact, Krol says that there aren’t typical symptoms associated with teething.
“Many people will assume that if a child is drooling a lot, if they’re fussy, if they’re crying, if they have any array of symptoms that it can be attributed to teething,” he told Healthline. “But the literature tells us that it’s hard to tie any of those things directly to teething. They can be caused by a variety of other things.”
These behaviors are also typical of 6-month-old infants, whether they’re teething or not.
However, diarrhea, vomiting, and fever are never symptoms of teething. These symptoms can be caused by more serious conditions. And because they can quickly become very serious for infants, parents should call a doctor.
Infants who are teething are old enough for other medications such as ibuprofen (Advil) and acetaminophen (Tylenol).
But Krol says parents should avoid using any type of medication if they think their child has teething symptoms.
“When balancing both the science as well as the risk I err on not encouraging any medications for teething,” he said.
When parents give medications to infants, there’s always a risk that the infant absorbs too much. Instead, Krol recommends that parents be soothing and loving to a child that is having trouble with teething.
If a child has sore gums, parents can freeze teething rings. He also suggests parents freeze a wet washcloth, wrap it around their finger, and rub it on the child’s gums.