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FDA warns against prescription lidocaine for teething pain.

Prescription oral viscous lidocaine should not be used to treat teething pain, as it can lead to serious harm or even death in infants and young children, according to a safety announcement issued by the Food and Drug Administration.

In 2014, the agency reviewed 22 case reports of serious adverse reactions in children aged from 5 months to 3.5 years who were either given oral viscous lidocaine 2% solution for the treatment of mouth pain or had accidental ingestions. Of the 22 cases identified, 6 resulted in death, 3 were categorized as life threatening, 11 required hospitalization, and 2 required medical intervention without hospitalization. The symptoms of toxicity from too much viscous lidocaine can include seizures, severe brain injury, or heart problems.

Oral viscous lidocaine solution is not approved to treat teething pain.

The FDA is requiring that a boxed warning be added to the product label, indicating that the drug carries a significant risk of serious medical conditions from ingestion.

In addition, the FDA announced it will require revisions to the Warnings and Dosage and Administration sections of the drug label to include additional instructions for dosing and a section describing the risk of severe adverse events if ingested.

In 2011 the FDA issued a warning that topical over-the-counter teething preparations containing benzocaine can lead to methemoglobinemia, a rare but occasionally fatal condition that results in a large decrease in the amount of oxygen in the blood.

Benzocaine gels and liquids are sold over the counter with brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and various store brands.

The FDA recommends that parents and caregivers follow the American Academy of Pediatrics' recommendations for treating teething pain: Use a teething ring that has been chilled in the refrigerator or gently rub the child's gums with your finger.

mbock@frontlinemedcom.com

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Author:Bock, Mike
Publication:Pediatric News
Date:Jul 1, 2014
Words:304
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