Benzocaine sprays, gels, and liquids, used as anesthesia during medical procedures and as a treatment for tooth and gum pain, have been associated with a serious and potentially fatal blood disorder called methemoglobinemia. Benzocaine sprays are marketed under different brand names such as Hurricaine, Cetacaine, Exactacain, and Topex. Benzocaine gels and liquids are sold under the names Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands. In April 2011, the U.S. Food & Drug Administration (FDA) issued a safety alert about this risk, but benzocaine product labels do not currently contain a warning about their association with methemoglobinemia. Methemoglobinemia is a disorder characterized by the presence of a higher than normal level of methemoglobin (metHb) in the blood.
If you or a loved one were diagnosed with methemoglobinemia following use of a benzocaine product, you may be entitled to compensation. Our benzocaine injury lawyers are offering free lawsuit evaluations to anyone who suffered this blood disorder because of one of these products. To find out how we can help, please contact one of our benzocaine injury lawyers today.
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.
The FDA first warned about methemoglobinemia associated with the use of benzocaine sprays in 2006. In the alert issued in April 2011, the FDA said it had received 72 new cases of methemoglobinemia, including three resulting in death, associated with the use of benzocaine sprays, bringing the total to 319 cases.
According to the FDA, methemoglobinemia involving benzocaine gels and liquids occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
According to the FDA, this side effect does not appear to be dose-related, because many reported cases occurred after administration of a single benzocaine spray. With liquids and gels, methemoglobinemia may occur after a single application or multiple applications, and can begin within minutes or hours of application. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, including concentrations as low as 7.5%.
In its health alert, the FDA advised the following:
- Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
- Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label. Consumers should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.