Product News and Recalls

FDA Issues Lidocaine Warnings

US FDA warns that use of lidocaine in small children can lead to health issuesThe Food and Drug Administration (FDA) recently announced that manufacturers of oral viscous lidocaine will be required to have a “Boxed Warning,” which is the strongest level of warnings the FDA may require. The warning is specifically directed at use of lidocaine to relieve teething pain in children aged five months to three-and-a-half years old.

Many parents have been known to use oral viscous lidocaine and other topical pain relievers to help ease teething discomfort in their small children. Furthermore, doctors prescribe lidocaine to an estimated 36,000 children under the age of two on an annual basis.

The Boxed Warning

Oral viscous lidocaine is not FDA-approved for teething children, and the new label will warn parents of the risks of using the product on their children. According to the FDA, lidocaine that is rubbed on the gums tends to wash off within minutes, causing the baby to swallow the drugs. Accidentally ingesting too much lidocaine can cause the following health issues in small children:

  • Heart problems;
  • Serious brain damage;
  • Seizures;
  • Other negative reactions; and
  • Death.

Twenty-two separate cases involving severe reactions to lidocaine in small children resulted in two children requiring a doctor’s attention, 11 hospitalizations, three reactions that were life-threatening, and six deaths.

FDA warnings warn against use of oral lidocaine in teething childrenThe FDA has previously issued warnings regarding children and over-the-counter pharmaceuticals that use benzocaine as an active anesthetic ingredient. Those products include Orabase, Orajel, Hurricaine, and Anbesol. Ingestion of benzocaine products can lead to a lack of oxygen in a child’s bloodstream, which can cause serious health complications and even death.

Up until this point, makers of viscous lidocaine products have not adequately warned parents of the dangers of using the products on babies and small children. The FDA hopes that the new Boxed Warning will alert parents and other caregivers to the dangers of using oral viscous lidocaine for their small children. Instead, the FDA and pediatric medical professionals recommend using a chilled washcloth or teething rings to ease nerve pain, or to gently massage their gums with your fingers.

Consult an Attorney

If your child has suffered injury or illness due to oral viscous lidocaine or similar products, you should consult with a products liability attorney as soon as possible. The lawyers at Lopez McHugh, LLP are committed to helping victims who have suffered injury from dangerous pharmaceuticals and other products. We offer free consultations, so do not hesitate to call our office at 877-737-8525.