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FDA Issues Warnings About Medicines Used For Teething Infants

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Important info for parents of infants and toddlers, the FDA is warning that prescription oral viscous lidocaine 2 percent solution should NOT be used to treat infants and children with teething pain.

The FDA is now requiring what they call a “Boxed Warning”, their strongest warning, to be added to the drug label to highlight this information.  Oral viscous lidocaine solution can cause serious harm, including death.

The FDA is now saying that parents and caregivers should follow the American Academy of Pediatrics’ recommendations for treating teething pain:

  • Use a teething ring chilled in the refrigerator (not frozen).
  • Gently rub or massage the child’s gums with your finger to relieve the symptoms.

They also say that topical pain relievers and medications that are rubbed on the gums 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.

In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions.

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