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Oral Lidocaine to Require New Boxed Warning

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Jarod Cassidy3 years ago

The U.S. Food and Drug Administration (FDA) is advising against the use of oral viscous lidocaine 2% solution for infants and children who are teething due to a risk of serious harm and death.

The regulator stated that it will require a new boxed warning label that addresses the drug's risk to children.

About the Lidocaine Advisory

“Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.” – U.S. Food and Drug Administration as published by Medscape

According to Medscape, the FDA has reviewed 22 case reports of serious adverse events, including death, involving children and infants who were given oral lidocaine for treatment of mouth pain or ingested the drug accidentally.

The FDA stated that topical pain relievers, like lidocaine, that are rubbed on the gums are not useful in treating young children because the medication will wash out a baby’s mouth within minutes.

Further, the FDA stated that when young children ingest too much viscous lidocaine, they can suffer from seizures, brain injury, and cardiovascular problems.

The FDA cited a number of cases in which overdose due to incorrect dosing or accidental ingestion resulted in young children being hospitalized or dying.

Other Side Effects of Lidocaine 2%

The following adverse events have also been observed in patients using Lidocaine 2%:

  • Drug toxicity
  • Chest pain
  • Nerve injury
  • Atrial fibrillation
  • Convulsion
  • Hypersensitivity


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