According to a press release from the U.S. Food and Drug Administration, the homeopathic teething tablets and gels might be putting at risks babies’ health. The FDA made it clear that they are still investigating, which means no study relates the teething products to deaths nor severe symptoms. Still, some companies removed their goods from the market.
The release was made public September 30 in the FDA official website but is until now that the message reached Americans. The FDA warns parents and caregivers that the possibly dangerous products are distributed by CVS, Hylands, and other retail stores, and online.
Some of the symptoms associated with teething tablets and gels are seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, difficulty urinating, constipation, or agitation after using the products.
There is not a conclusion because the FDA is currently investigating the products and their effects on children. The adverse events were reported to the agency and were linked to teething products but with not enough evidence.
This is not the first time that the FDA is suspicious about teething tablets and gels. In 2010, the agency released a safety alert in the homeopathic products for containing belladonna. Not all distributors had the component, but Hyland’s product did, and they had to recall their tablets and gels at that time.
Homeopathic teething tablets and gels have been not approved by the FDA for safety or efficacy. But now, after the reports of deaths and symptoms related to teething products, the agency is investigating.
The FDA is working to figure out if the products are dangerous for babies. In the midtime, parents and physicians are urged to stop using teething products and report if they have noticed any adverse effects after using teething tablets or gels.
The FDA has no evidence but still finger points teething product companies
Hyland made another recall of their goods in the market related to teething and stopped distributing them in the United States. In the company’s official website, a letter was posted explaining that the recent FDA warning has created confusion among Hyland consumers and limited the access to the medicines.
“Hyland’s has not been made aware of any data that supports the claims in the warning against our teething tablets and gels. Our understanding is that the Food and Drug Administration’s investigation of these products is still ongoing. 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,” said the company in an email sent to CNN.
Hylands employees stated that the FDA actions, considering that the agency does not have proves linking teething tablets and gels to death and other symptoms in children, are burdensome. The provoked panic by the FDA undermines the agency because it puts people in a difficult place, where the public does not know who to trust.
As an alternative to teething products, the American Academy of Pediatrics suggests that babies in pain because of teething can be massaged in their gums with a clean finger. A solid teething ring or a clean wet, cold washcloth can also be used to relieve the baby’s pain. Frozen bananas, berries or bagels are also recommended.
Acetaminophen can be given to the child but consulting the dose with a physician is recommended.
Source: FDA