The FDA has reports of ten children deaths due to homeopathic teething tablets, and 400 adverse events associated with the tablets.
They warn caregivers to stop using the products, which are used to help with comforting teething babies. They recommend taking children to a pediatrician as soon as possible if the child exhibits any issues.
The FDA is investigating the clashing events and the incidents associated with the consequential losses, as admitted by them.
In an affirmation sent to CNN, Hyland’s, a maker of organic teeth tablets and gel, said: “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. We continue to request any available information and statistics from the FDA.”
The company made a statement this week that it will discontinue the products in the US.
“This cautioning has spawned confusion among parents and limited access to the medicines,” the letter from Hyland’s employees stated. “Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA.”
“We look forward to the future of organic medicines as we work in partnership with the FDA,” the letter said.
Also, the agency sent out a statement in 2010, warning about the tablets and Hyland’s announced a recall back then. After further examination, the FDA announced it found an adverse amount of belladonna within the tablets.
Hyland’s Teething Tablets
Since 2010, Hyland’s said, it reformulated its product to cut down on the amount of belladonna. Hylan proposed an improvised system to monitor, investigate and oversee all safety reports on their products.
The American Academy of Pediatrics’ or “AAP” has advised parents to stop using teething tablets that incorporate belladonna and gels with benzocaine, citing the FDA warnings and the potential side effects.
Instead of teething tablets, the AAP recommends parents gently rub the child’s gums with a clean finger when in pain. Use a solid teething ring or clean, cold, wet washcloth. Frozen bananas, berries or bagels are helpful as well. Parents can also give a weight-appropriate dose of acetaminophen but should ask the child’s doctor about an appropriate dose.