FDA Boxed Warning Over Lidocaine. Prescription 2 percent Lidocaine Viscous, has long been used to numb infants’ and children’s gums during teething, and has recently been the focus of a stringent U.S. Food and Drug Administration (FDA) warning. The agency has also issued communications concerning over-the-counter (OTC) brands of lidocaine viscous and OTC topical benzocaine products.
Our firm is pursuing lawsuits on behalf of children and infants who may have been injured or who may have died following use of these teething products.
Federal Regulators Recommend Lidocaine Not Be Used for Treating Teething Pain, New Boxed Warning
Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children may lead to serious harm, including death.
In June 2014, the U.S. Food and Drug Administration (FDA) issued a Safety Announcement warning that the prescription medication, oral viscous lidocaine 2 percent solution, should not be used in the treatment of infants and children with teething pain. The agency also mandated a new Boxed Warning. “We are requiring a new Boxed Warning, FDA’s strongest warning, to be added to the drug label to highlight this information,” the agency wrote. The Black Box is required to highlight this information on the drug’s labeling.
The FDA also required that revisions be made to the “Warnings and Dosage and Administration” sections of the drug label that describe the risk of severe adverse events. The sections must also include additional instructions for dosing when oral viscous lidocaine is prescribed for approved uses.
Healthcare Professionals Advised to Follow American Academy of Pediatric Recommendations
The agency notes that health care professionals should not prescribe or recommend oral viscous lidocaine for teething pain and suggests that parents and caregivers follow the American Academy of Pediatrics’ (AAP) recommendations for treating teething pain. The agency also recommends that parents and caregivers do not use OTC topical medications for teething pain as some may be harmful and recommends, instead, that (AAP) recommendations to minimize teething pain be followed:
- Use a teething ring that has been chilled in the refrigerator; do not use a frozen teething ring.
- Gently rub or massage the child’s gums with your finger to relieve symptoms.
Teething Products Considered Unnecessary, May Lead to Serious Injury, Death
Topical pain relievers and medications rubbed on the gums are both unnecessary and not useful because the products wash out of the baby’s mouth in just a few minutes, the agency has pointed out. Cases of overdose due to wrong dosing or accidental ingestion have led to babies and children being hospitalized or dying. In fact, when too much viscous lidocaine is given to infants and young children, or when children or infants swallow too much of the medication, they may suffer from serious side effects, including:
- Severe brain injury
- Cardiac problems
“It’s been shown that when too much Lidocaine Viscous gets swallowed it can cause seizures, brain injuries and problems with the heart,” dentist Dr. Peter Piché told My North. The agency review revealed cases in which infants died following treatment with the prescription strength medication. “The problem comes when too much is given,” Piché says. “The husband gives it, and the mom doesn’t know that, so she gives more. The product is flavored, so the baby is intentionally licking his gums and swallowing the medicine.”
Piché notes that, “Parents should know that teething pain is a short term thing. It will pass.”
FDA Review of Infant Lidocaine Deaths, Serious Reactions
In 2014, the FDA reviewed 22 case reports of significant adverse reactions that included deaths in babies and children from 5 months of age to 3.5 years of age and who received oral viscous lidocaine 2 percent solution to treat mouth pain, such as teething and stomatitis (inflammation of the mouth), or who had suffered an accidental ingestion.
Over-the-Counter Topical Benzocaine Teething Preparations
The FDA also communicated safety concerns regarding the use of OTC topical benzocaine teething preparations and warned in 2011 that use of OTC benzocaine gel products for teething or mouth pain may cause a rare, but serious, condition called methemoglobinemia. Methemoglobinemia leads to a significant decrease in the oxygen carried through the bloodstream. The condition is life-threatening and may be deadly.
The agency indicated that it has been receiving reports of methemoglobinemia in infants and children that are associated with OTC benzocaine gels and liquids since the 2011 warning was issued.
OTC benzocaine gel and liquid products are sold under a variety of brand names, including Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, as well as various store brands.