US Food and Drug Administration (FDA) regulators are warning that young children who are teething and experiencing pain should not be given lidocaine, a topical painkiller, due to the serious and even fatal risks associated with the drug.
In a 26 June announcement, FDA said that the application of oral viscous lidocaine 2% solution had been associated with at least 22 reports of serious adverse reactions, "including deaths," in young children and infants. At least six children died, and all but two required hospitalization.
Those reports included seven accidental ingestions of the drug, regulators noted. Other cases involved problems with the application of the drug (7) and accidental overdose due to prescribing error (4).
To warn parents of the dangers associated with the drug, FDA said it would require lidocaine manufacturers to label their products with a black box warning (sometimes referred to as a "boxed warning"), the most serious type of warning found on a drug's label.
FDA will also require manufacturers to revise their respective Warnings and Dosage and Administration sections of their labels to describe the risk of severe adverse events, the regulator said.
Regulators said safer, non-drug alternatives exist to ease pain associated with teething, which occurs when a child's teeth first break through its gums.
"Too often well-meaning parents, grandparents and caregivers want to soothe a teething baby by rubbing numbing medications on the tot's gums, using potentially harmful drugs instead of safer, non-toxic alternatives," FDA wrote in a consumer update posted on its website.
Instead, FDA recommended that parents follow the American Academy of Pediatrics' recommendations on teething pain, which include the use of a chilled teething ring or a digital massage of the child's gums.
Other painkillers, including OTC and other prescription painkillers, should also be avoided, FDA explained in its notice.
The regulator has previously issued a warning regarding the use of benzocaine (brand name: Orajel, Anbesol) for teething pain, saying it can lead to methemoglobinemia, a rare condition which causes a drop in blood oxygen levels.
FDA estimates that between 35,000 and 50,000 children are given lidocaine each year.