Based on its review of 22 reports of serious adverse reactions, including deaths, in 2014, the U.S. Food and Drug Administration is calling for a boxed warning on a prescription drug used to treat teething pain. The children in those reports ranged from 5-months-old to 2 and a half. At the same time, the agency is reiterating its rebuke of the use of over-the-counter topical solutions for the treatment of teething pain.
The prescription drug of FDA concern is oral viscous lidocaine 2 percent solution, which, according to the agency’s June 2014 safety alert, “is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.”
The FDA cites dosing issues and practical problems.
“Topical pain relievers and medications that are rubbed on the gums,” the FDA wrote, “are not necessary or even useful because they wash out of the baby’s mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.”
Putting it simply in regard to viscous lidocaine, the FDA wrote, “Health care professionals should not prescribe or recommend this product for teething pain.”
The FDA took aim at topical benzocaine teething substances in 2011, warning that the use of such preparations can cause a rare but serious condition known as methemoglobinemia.
“This condition,” according to the FDA, “results in a large decrease in the amount of oxygen carried through the blood. It is life-threatening and can result in death. … OTC benzocaine gels and liquids are sold under different brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and various store brands.”
The product liability attorneys at Reich & Binstock will investigate these types of injury claims as well. Anyone who knows of a situation worthy of observation should call toll-free one of the experienced product liability attorneys at Reich & Binstock for a free review of the situation.
