This week the U.S. Food and Drug Administration notified health care professionals and patients that it continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with: •benzocaine gels and liquids sold over-the-counter for pain relief from teething, canker sores, and irritation of the mouth and gums. Benzocaine gels and liquids are sold over-the-counter under brand names like Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands. And; •benzocaine products used as a spray during medical procedures to numb the mucous membranes of the mouth and throat. These sprays are marketed under brand names like Hurricaine, Cetacaine, Exactacain, and Topex. According to the FDA, methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Cases have occurred mainly in children 2 years or younger who were treated with the gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. Dr. K.J.S. “Sunny” Anand is chief of Critical Care at Le Bonheur Children’s Hospital and The University of Tennessee Health Science Center. He is an internationally known expert in pain in infants and children. He had this to say about the warning: “Children are not little adults, and they respond differently to medicines. Because of their changing size and body structure, parents need to be careful about using drugs in children that are easily tolerated in adults. Benzocaine sprays and lozenges are another example of this. The warning from the FDA is timely and important - parents should be careful about using these OTC products in small infants and children.” The FDA says that these products should not be used on children younger than 2 years old unless under the advice and supervision of a health care professional. Ask your pediatrician if you have any questions or concerns.

This week the U.S. Food and Drug Administration notified health care professionals and patients that it continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with:

 •benzocaine gels and liquids sold over-the-counter for pain relief from teething, canker sores, and irritation of the mouth and gums. Benzocaine gels and liquids are sold over-the-counter under brand names like Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands.  And;

 •benzocaine products used as a spray during medical procedures to numb the mucous membranes of the mouth and throat.  These sprays are marketed under brand names like Hurricaine, Cetacaine, Exactacain, and Topex.

According to the FDA, methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate.

Cases have occurred mainly in children 2 years or younger who were treated with the gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use.

Dr. K.J.S. “Sunny” Anand is chief of Critical Care at Le Bonheur Children’s Hospital and The University of Tennessee Health Science Center.  He is an internationally known expert in pain in infants and children.  He had this to say about the warning:  “Children are not little adults, and they respond differently to medicines. Because of their changing size and body structure, parents need to be careful about using drugs in children that are easily tolerated in adults.  Benzocaine sprays and lozenges are another example of this.  The warning from the FDA is timely and important - parents should be careful about using these OTC products in small infants and children.”

The FDA says that these products should not be used on children younger than 2 years old unless under the advice and supervision of a health care professional.  Ask your pediatrician if you have any questions or concerns.