FDA issues safety warning against prescription of lidocaine solution for teething pain
June 26, 2014
Silver Spring, Md
.—Oral viscous lidocaine solution is not approved to treat teething pain, and health care professionals should not prescribe the drug to treat infants and children with teething pain, warned the U.S. Food and Drug Administration June 26 in a drug safety communication.
The FDA now requires a Boxed Warning, its strongest warning, to be added to the drug label for oral viscous lidocaine 2 percent solution to highlight its advisory. In addition to the Boxed Warning, the agency now requires revisions to the Warnings and Dosage and Administration section of the drug label to describe risk of severe adverse events and to include additional dosing instructions when the drug is prescribed for approved uses.
Too much viscous lidocaine given to infants or young children can result in seizures, severe brain injury and heart problems, and misuse has led to hospitalizations and deaths, the FDA warns. In 2014, the FDA reviewed 22 case reports involving serious adverse reactions to oral viscous lidocaine solution, including six deaths, in infants and young children 5 months to 3.5 years old.
The FDA also warns that parents and caregivers should not use over-the-counter topical medications for teething pain because some of them can also harm infants and children. These products are not necessary and are not useful, warns the FDA, because they wash out of a baby's mouth within minutes.
Instead, parents and caregivers should follow the American Academy of Pediatrics' recommendation for treating teething pain, the FDA suggests. The AAP advises using a teething ring chilled, though not frozen, in the refrigerator and gently rubbing the child's gums with a finger to relieve pain.
In 2011, the FDA also advised of safety concerns related to use of over-the-counter benzocaine gels and liquids to treat teething pain. A Consumer Update for this related issue is available at fda.gov
Dentists can refer their patients to MouthHealthy.org
for more information on safety concerns surrounding over-the-counter benzocaine
gels and liquids.
The American Dental Association recommends that a dentist examines a child within six months after the first tooth comes in and no later than the first birthday.
The ADA Catalog also offers several education materials for parents of babies and young children, including these two brochures:
• Your Child's First Visit to the Dentist (W110
). The six-panel brochure is available to members in packs of 50 for $26 and $39 retail.
• Your Child's Teeth from Birth to Age 6 (W236
). The eight-panel brochure is available to members in packs of 50 for $27 and $40.50 retail.
Save 15 percent on all ADA Catalog products with promo code 14145 through August 15. These brochures and many others are available at adacatalog.org
or by calling 1-800-947-4746.