FDAcommunication

provide the following information when Risk of methemoglobinemia counseling patients and caregivers seek­ in the medicine cabinet ing products containing benzocaine: n Children younger than 2 years should not receive benzocaine products Patients need to know about benzocaine except under the advice and supervi­ sion of a health professional. Benzocaine-containing products may patients with a reported methemoglobin n Use alternative methods for reduc­ cause a rare but serious and possibly level of 30% to 55% or who were admin­ ing pain from teething. The Ameri­ fatal condition called methemoglobin­ istered methylene blue regardless of can Academy of Pediatrics recom­ emia. Methemoglobinemia is a condition the level of methemoglobin. One death mends using a teething ring chilled Bwhere too much of the hemoglobin in red was reported, but it is unclear from the in the refrigerator, gently rubbing blood cells becomes unable to bind and information provided whether the use of the child’s gums with your finger, carry oxygen. Labels of OTC benzocaine benzocaine gel contributed to the out­ or contacting a health professional products do not contain warnings about come. Most of the cases involved pediat­ to identify other treatments if these methemoglobinemia. FDA is particularly ric patients, particularly children aged 2 methods do not provide relief. concerned about the use of OTC benzo­ years or younger who were administered n Use benzocaine gels and liquids caine products in children for relief of benzocaine gel for teething pain. sparingly and only when needed— teething pain because parents or care­ In 2006, FDA issued a Public Health not more than four times a day. givers may not be aware of or watch for Advisory about methemoglobinemia n Keep benzocaine products out of the signs and symptoms of this condition with the use of benzocaine sprays dur­ reach of children. when using the products. ing medical procedures. Since then, FDA n Discuss the signs and symptoms of has received reports of 72 new cases of methemoglobinemia, including pale, Background methemoglobinemia associated with the gray, or blue-colored skin, lips, and Benzocaine is the main ingredient in use of benzocaine sprays, including 3 nail beds; headache; lightheaded­ many OTC gels and liquids applied to resulting in death, bringing the total to ness; shortness of breath; fatigue; the gums or mouth to relieve pain from 319 cases as of March 16, 2011. Of the and tachycardia. a variety of conditions, such as teething, 319 cases, 7 were deaths, 32 cases were n Symptoms may appear within min­ canker sores, and irritation of the mouth categorized as life threatening, and 216 utes to 1 or 2 hours after using ben­ and gums. Benzocaine gels and liquids were categorized as serious. zocaine. Symptoms may occur with are sold under different brand names A review of the 319 cases indicated the first or subsequent applications such as Anbesol, HurriCaine, Orajel, that the development of methemoglobin­ of benzocaine. Seek medical atten­ Baby Orajel, Orabase, and store brands. emia after treatment with benzocaine tion immediately if methemoglobin­ Benzocaine is also sold in other sprays may not be related to the amount emia is suspected. forms such as lozenges and spray solu­ applied. In many cases, methemoglobin­ n Patients who have breathing prob­ tions. The spray solutions are marketed emia was reported following the admin­ lems such as asthma, bronchitis, or under different brand names such as istration of a single benzocaine spray. emphysema, patients with heart dis­ HurriCaine, Cetacaine, Exactacain, and In other cases, methemoglobinemia ease, and patients who smoke are at Topex and are used during medical pro­ resulted after excessive amounts were greater risk for complications related cedures to numb the mucous membranes applied. to methemoglobinemia. of the mouth and throat. The amount of benzocaine contained Pharmacists are encouraged to in a single spray varies across the differ­ report adverse events related to the use FDA data ent products and depends on the concen­ of these products to FDA’s MedWatch A search of FDA’s Adverse Event Report­ tration of the solution, the amount of time Safety Information and Adverse Event ing System database through March 16, the actuator is depressed, the residual Reporting Program at www.fda.gov/ 2011, identified 21 cases of methemoglo­ volume in the can, and the spatial orienta­ MedWatch/report.htm. binemia associated with the use of OTC tion of the can during spraying. Symptoms For more information, visit http:// benzocaine gel or liquid products. Methe­ may appear within minutes to 1 or 2 hours apha.us/uQZOzp. moglobinemia has been reported across after using benzocaine. —Brenda J. Rose, PharmD a range of benzocaine gels and liquids, Contributing writer even at the lowest concentrations. Counseling tips Of the 21 cases, 10 were categorized As members of the health care team most Brenda J. rose, Pharmd, is a member of as life threatening, defined as those often available at the point of purchase, the Health Professional Liaison Program in the FDA Office of Special Health Issues. She patients with a reported methemoglobin pharmacists have an opportunity to help acknowledges the help of subject matter level greater than 55%. Six cases were patients and caregivers select an appro­ experts in the Center for Drug Evaluation and categorized as serious, defined as those priate OTC product. Pharmacists should Research, FDA.

58 Pharmacy Today • January 2012 www.pharmacytoday.org