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FDA warns against using benzocaine products in children under two
Posted 9/25/2012 Updated 9/25/2012
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Commentary by Capt. Megan Kreycik
7th Aerospace Medicine Squadron
9/25/2012 - DYESS AIR FORCE BASE, Texas -- When a baby is teething, mom and dad want to help stop the pain. For this reason, gel and spray products are available that contain benzocaine, a topical anesthetic. However, the Food and Drug Administration has warned that these products should not be used for children under the age of 2, except under the advice and supervision of a health care professional.
The reason?
Benzocaine has been associated with a rare but serious, and sometimes fatal condition called methemoglobinemia.
What is methemoglobinemia?
In simple terms, it's a disorder that causes the amount of oxygen the blood can carry to be greatly reduced. Although it can occur in older children and adults, children under 2 appear to be particularly at risk. Since 2006 the FDA has received 29 reports of benzocaine gel-related cases of methemoglobinemia, 15 of which were children under the age of 2.
According to the FDA's consumer update, some of the symptoms of methemoglobinemia include:
·pale, gray, or blue colored skin, lips and nails
·shortness of breath
·fatigue
·confusion
·headache
·light-headedness
·rapid heart rate
The ADA's Seal of Acceptance Program currently has two topical benzocaine-containing pain relief products that bear the official ADA seal, neither intended for children under 2. These products are Benzodent Dental Pain Relieving Cream by Chattem, and Professional Strength Kanka Mouth Pain Liquid by Blistex. Both products contain 20 percent benzocaine and contain the following label statements:
·For the temporary relief of pain due to minor irritations of the mouth and gums caused by dentures or orthodontic appliances or minor injury to mouth and gums. Kanka also says that it can be used to help relieve pain from canker sores.
·Children under 2 years of age: consult a dentist or physician.
·Children under 12 years of age should be supervised in the use of this product.
·Keep out of reach of children.
For more information on these and other oral care products that carry the ADA seal, visit the ADA seal page on MouthHealthy.com. Products that bear the ADA seal have undergone a rigorous, independent, scientific review to ensure that they meet ADA criteria for safety and effectiveness.
Article content obtained from ADA.org.
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