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FDA issues safety warnings on drugs to treat pain in teething babies

The U.S. Food and Drug Administration warned health care professionals in a June 26 safety alert that they should not prescribe oral viscous lidocaine to treat infants and children with teething pain.

Too much of the drug given orally 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. Aside from potential danger, these products are not necessary and are not useful, according to the FDA, because they tend to 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

The American Dental Association has information on safety concerns surrounding over-the-counter benzocaine gels and liquids on its consumer website,

The ADA recommends that parents and caregivers schedule a visit to the dentist within six months after a child’s first tooth comes in and no later than the first birthday.

©2010 American Dental Association. All rights reserved. Reproduction or republication is strictly prohibited without the prior written permission from the American Dental Association.

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