The U.S. Food and Drug Administration announced on April 7, 2011 that it has received several reports of methemoglobinemia. This is a rare but serious blood disorder that is linked with pain relievers that contain benzocaine and form a major ingredient added to teething gels.
The agency stated that methemoglobinemia has been reported with all potency of benzocaine gels and liquids. This has been reported in concentrations that are as low as 7.5 percent. The cases involving low concentration products were mainly found in children ages 2 or younger who were treated with the benzocaine gel form for teething.
The FDA is advising health care professionals and parents to follow the teething guidelines for teething, which recommends giving a child a chilled teething ring or gently rubbing or massaging his gums with a finger. This is far more effective and safe than using benzocaine to relieve the discomfort that is associated with teething.
Methemoglobinemia is a serious blood disorder that reduces the amount of oxygen in the blood stream and in severe cases can lead to death and is especially dangerous in children.
Benzocaine gels and liquids are sold under the brand names Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase. It is sold in several different forms right from gels and liquids, to lozenges and spray solutions to treat a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.
The symptoms of methemoglobinemia include pale, gray or blue-colored skin, lips, and nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; and rapid heart rate.
For consumers who use benzocaine, the FDA has recommended that they use the smallest proportion possible in the least amount of potency. As far as possible, use the gels with it in it less frequently than they would otherwise use. At no instant should it be used more. The ADA is thinking of making health care professionals discuss the signs and symptoms of methemoglobinemia with patients and tell them to look for signs and symptoms when using benzocaine products. Patients need to look for medical attention immediately if they suspect methemoglobinemia. The FDA will continue to work on this safety alert.