Safety Alerts & Recalls

What does this mean?

If your child has teething pain, do not use prescription viscous lidocaine 2% solution. The FDA is also discouraging the use of over-the-counter (OTC) topical medications that are rubbed on the gums for teething pain because they are not useful as they wash out of the baby’s mouth within minutes. Some of the OTC teething products, such as those containing benzocaine, can be harmful.

If your child has teething pain, you can follow the recommendations of the American Academy of Pediatrics for treatment:

• 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.

Please follow up with your child’s doctor if you have any questions about treating teething pain. If you think your child is experiencing side effects from any teething pain product, please seek medical attention right away.

Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: http://www.fda.gov/Safety/MedWatch/default.htm

Oral Lidocaine for Teething Pain May Cause Harm

The US Food and Drug Administration (FDA) has warned that prescription oral viscous lidocaine 2% solution should not be used to treat teething pain in infants and children. The FDA is requiring a Boxed Warning be added to the prescribing information for these products. Oral viscous lidocaine solution is not approved by the FDA to treat teething pain, and its use in infants and young children can cause serious harm, including death.

When too much viscous lidocaine is given to infants and young children or if they accidentally swallow too much, it can result in seizures, severe brain injury, and heart problems. Cases of overdose due to the wrong dosage or accidental ingestion have resulted in infants and children being hospitalized or dying.

For more information, please visit: more information here

Source: FDA
Publication Date: 2014-07-03
Last Updated: 2014-07-03

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