The FDA has released an official warning to parents with small children undergoing the teething process. There have been ten deaths of children that used homeopathic tablets, reports ABC 7. Also, there have been 400 adverse events reported in association with the utilization of these tablets.
These homeopathic teething tablets as well as teething gels are currently under investigations and may soon be discontinued by the FDA. During their investigation, the FDA found that adverse side effects experienced by small children were linked to the tablets. However, it should be noted, that the inquiry has not yet completed, reports Time Magazine.
As of right now, the FDA is still currently investigating the tablets that have been distributed by CVS Pharmacies and Hyland’s. These tablets have been linked with difficulty breathing, seizures, lethargy and a host of other symptoms, reports SF Gate. The deaths associated with these tablets have not been confirmed, but are still being investigated.
Teething Without Tablets
The FDA has already made a statement that parents can easily manage teething without using these tablets and gels. They stated that parents who have concerns over their child’s teething can consult with their child’s pediatrician for alternatives, reports SF Gate.
Hyland’s will no longer be distributing the product, according to ABC News. As the maker of the teething tablets and gel, the company stated that they were not aware of any claims that support the warnings from the FDA. They also said that the investigation was still ongoing. Furthermore, Hyland’s made it clear that there is no medical or even statistical evidence to support the claims or warning from the FDA.
Despite their letter, Hyland’s decided to stop distributing the product because they feel the FDA’s warning has created confusion among parents. They made their announcement on October 11th, states Time.
There is no recall as of yet on the product, and the FDA is not forcing one at this time. However, the products that are affected by the FDA warning include Hyland’s Baby Teething Tablets, Nighttime, and Teething Gel. CVS had their version of the gel as well that they have pulled from the shelves, says ABC News.
This is not the first warning from the FDA regarding Hyland’s. According to SF Gate, they were subject to one back in 2010. This was because there were inconsistencies with the amount of belladonna they placed in their teething tablets, and the FDA was concerned that this could lead to a toxic level. Also, they stated that the containers were not child-safe, which resulted in children consuming more tablets than they should.
Hyland’s has reformulated their tablets since then and also changed their production process. They stated that they have investigated all safety reports of their products and implemented policies to correct any concerns. They also say on their site, according to ABC News, that they have worked to ensure there are no risks to consumers.
Hyland’s website still states that they are confident their products are safe for use, reports Time.