Newsletter
SILVER SPRING, Md./WASHINGTON, USA: Last week, the Food and Drug Administration (FDA) announced that a box warning on prescription products containing viscous lidocaine solution is now required that states that such products should not be used to treat teething pain in children. In response, a U.S. trade association has voiced concerns that such suggestions create confusion among consumers and health care providers. It has urged the FDA to clarify its announcement.
A box warning on a drug label is the FDA's strongest warning. In the current case, the agency required a new box warning for oral viscous lidocaine 2 percent solution because it is not approved to treat teething pain and could cause serious harm in infants.
In its safety announcement issued on June 26, the FDA called upon health care professionals not to prescribe or recommend this product for teething pain. In addition, the agency instructed parents and caregivers to use a chilled teething ring or to rub the child's gums with a finger to relieve the symptoms.
The FDA further emphasized that topical pain relievers rubbed on the gums are not necessary. When administered incorrectly, viscous lidocaine can cause seizures, severe brain injury and heart problems. Of the 22 cases of adverse reactions to the product that were reviewed by the FDA, six cases resulted in death, three were categorized as life-threatening, 11 required hospitalization, and two required medical intervention. In many cases, caregivers did not follow the prescriber's directions or gave additional doses.
Moreover, the FDA encouraged parents and caregivers once more not to use topical over-the-counter medications containing benzocaine for teething pain. In 2011, the agency had warned that using such gels for mouth pain could cause methemoglobinemia, a rare but life-threatening blood disorder.
In response to the benzocaine announcement, the Consumer Healthcare Products Association (CHPA), a trade association representing leading manufacturers and suppliers of over-the-counter medicines and dietary supplements, issued a press release stating that the FDA's suggestion regarding benzocaine does a disservice to parents and caregivers who use FDA-approved gels and medicines containing the anesthetic. The association criticized the FDA for not providing any data to support its change to the recommendations in 2011.
"Consumers should continue to have confidence that these medicines can be used safely and appropriately by following the label. We urge the FDA to clarify its position to consumers and follow the appropriate regulatory path," CHPA said.
The FDA stated that, since the issuance of the 2011 warning on benzocaine, it has received six new reports of methemoglobinemia cases in infants under the age of 2 associated with over-the-counter benzocaine gels and liquids.
