On April 7, FDA announced that parents and caregivers should not give OTC gel or liquid benzocaine products, such as Anbesol and Orajel, to children younger than 2 years old unless directed to do so by a physician.
The agency’s action comes in response to nearly two dozen reports of methemoglobinemia, a rare but potentially fatal condition in which the amount of oxygen carried through the bloodstream is greatly reduced, stemming from use of these medications.
As an alternative to the commonly used teething medications, the FDA referred parents to recommendations from the American Academy of Pediatrics, or AAP, that suggest gently rubbing or massaging their teething child’s gums or giving the child a firm rubber teething ring.
It is also suggested that parents and caregivers give teething babies something that is cold but malleable, such as a wet washcloth that has been wrung out, twisted like a rope, and frozen.
If these methods do not work, some pediatricians suggest that parents and caregivers provide a weight-appropriate dose of acetaminophen. However, proper dosages and per-day dosing limits should be maintained because of the risk of liver damage posed by the medication.
Some pediatricians discourage parents from treating their children with certain homeopathic remedies, such as teething tablets that contain belladonna and amber teething necklaces. Belladonna is a poison, and necklaces of any kind pose multiple safety risks with small children.
As for benzocaine, the FDA has said in its safety announcement that children younger than age 2 years should not be given the medication except on the advice of and with supervision by a physician. The agency also cautioned that the topical anesthetic should be used sparingly — no more than four times a day — and only when needed.
The FDA said that methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, including concentrations as low as 7.5 %. The products, which are used to treat canker sores and other irritations of the mouth and gums in addition to teething, have been associated with methemoglobinemia in adults as well as children.
Of the 21 cases reported to the FDA, 10 were considered life-threatening. Meanwhile, the FDA also has received more than 300 reports of methemoglobinemia associated with the use of benzocaine sprays to numb the mucous membranes of the mouth and throat, including 32 cases that were categorized as life-threatening. Three deaths have been reported. The agency issued a separate safety announcement related to those products, which include Hurricaine, Cetacaine, Exactacain and Topex.
The risks associated with methemoglobinemia and benzocaine are not yet included on the labels of any benzocaine products, according to the FDA.
The following is a list of OTC products containing benzocaine*:
|Americaine||Dent’s Maxi-Strength Toothache||Orajel Medicated Toothache|
|Americaine Hemorrhoidal||Dermoplast Antibacterial||Orajel Mouth Sore|
|Anbesol||Dermoplast Painrelieving||Orajel Multi-Action Cold Sore|
|Anbesol Baby||Detane||Orajel PM|
|Anbesol Cold Sore Therapy||Dry Socket Remedy||Orajel Ultra Mouth Sore|
|Anbesol Maximum Strength||Foille||Otocain|
|Baby Orajel||Freez Eez||Outgro|
|Banadyne||HDA Toothache||Red Cross Canker Sore|
|Benzocaine Burn Spray||Hurricaine||Rid-A-Pain Dental Drops|
|Boil Ease Maximum Strength||Kanka Soft Brush||Sting-Kill|
|Cepacol Sore Throat||Lanacane||Tanac|
|Cetacaine||Lanacane Maximum Strength||Thorets|
|Comfort Caine||Orabase with Benzocaine||Walgreens Oral Anesthetic Paste|
|Dentapaine||Orajel Denture Plus||Walgreens Zilactin-B|
|Dent’s Extra Strength Toothache||Orajel Maximum Strength||Zilactin Toothache and Gum Pain|
*This list is not all-inclusive
Reference: American Academy of Family Practice, FDA