News Talk 94.1/AM 1600 Where The Upper Cumberland Talks
One local pediatrician said the Food and Drug Administration’s warnings on benzocaine gels are “nothing new.”
The FDA released a statement last week saying use of the product could result in a potentially fatal blood condition in infants called methemoglobinemia.
Dr. James Batson of Cookeville Pediatrics Associates said the FDA had been warning people about the products for quite some time.
“My suspicion is that they either had some increasing reports of side effects,” Batson said, “or they got reports of people still recommending it even after so many years of it not being recommended.”
The FDA said reports of the fatal blood disease continued despite its warnings. The agency reviewed over 100 cases between 2009 and 2017, including four deaths.
Batson said he isn’t surprised it took so long for the FDA to announce the potential dangers of the products.
“The FDA doesn’t act quickly on many things,” Batson said. “Unless it’s a public emergency, they don’t act on a lot of things.”
Church and Dwight Co, Inc. announced they would discontinue four Orajel products following the FDA’s warnings.
However, Batson said despite the FDA’s warnings, the agency failed to provide a solution.
“The FDA constantly says things we use or used to use are not effective or have too many side effects,” Batson said. “But they almost never come up with anything else to use. It’s like they’re always taking things away.”
Batson said he recommends using a cold teething ring for infants in place of benzocaine products. Batson has rarely prescribed benzocaine products due to their availability on store shelves.
The FDA said it will seek legal action for companies who do not remove the product voluntarily.
