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FDA Warns Against Using Lidocaine in Teething Infants and Children

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The FDA has received 22 report of serious adverse reactions, including death, among children and infants 5 months to 3.5 years of age that were given oral viscous lidocaine to treat teething pain. Now, the federal agency is requiring a boxed warning on those products. The FDA found that when children and infants were given the wrong dose, or overdosed on the product, they suffered serious side effects including:

• Severe brain injury
• Heart problems
• Seizures
• Death

The 22 reported cases included 6 deaths, 11 hospitalizations, 3 life-threatening reactions, and 2 cases that needed medical attention.

The FDA is asking that this product not be administered to treat teething pain.

FDA Issues Warning in 2011 about Benzocaine

The FDA also issued a warning about the use of OTC (over the counter) benzocaine in April 2011, due to the risk of methemoglobinemia. Methemoglobinemia is a blood disorder that can cause headaches, fast heart rate, confusion, lightheadedness, pale, gray, or blue-colored skin, lips and nail beds, fatigue, and shortness of breath. At that time there were 21 reported cases of this blood disorder associated with the use of OTC benzocaine. Officials recommended that caregivers and healthcare providers not use the product on children younger than 2, and to use it sparingly. Products that contain benzocaine include Hurricaine, Orajel, Orabase, Anbesol and other store brands.

Since the 2011 warning the FDA received reports of 6 more cases of methemoglobinemia in children younger than 2 years old. Six of those children had to be hospitalized and three cases were life-threatening.

How to Treat Teething Pain

The FDA found that when topical pain relievers are rubbed on the gums, most of the medication is swallowed by the child, rather than helping with the pain. There are other ways to relieve the pain an infant or child experiences during the teething process. According to healthychildren.org by the American Academy of Pediatrics, teething starts when a baby is between 4 and 7 months old. It will not always cause pain, but when it does experts recommend:

• Teething rings-make sure they are made of firm rubber
• Use one of your fingers to gently massage the gums
• Brush any new teeth with a soft child’s toothbrush

The American Academy of Pediatrics also found that “pain relievers and medications that you rub on the gums are not necessary or useful since they wash out of the baby’s mouth within minutes.” It also found that these products can be harmful to your baby.