[Posted 04/07/2011] ISSUE: FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.
BACKGROUND: 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. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine 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. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.
RECOMMENDATIONS:
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.
Read the two Drug Safety Communications below for other specific recommendations for Healthcare Professionals, for Consumers and Caregivers and the Data Summary which supports these recommendations.
FDA is continuing to evaluate the safety of benzocaine products and the Agency will update the public when it has additional information. FDA will take appropriate regulatory actions as warranted.
For more information visit the FDA website at: [Web] and [Web].
This medicine is only for use in the outer ear canal. Do not take by mouth. Follow the directions carefully. Wash hands before and after use. Lie on your side or tilt head so that the ear is up. Pull the earlobe up and back (for adults), or down and back (for children), and instill the prescribed number of drops. Avoid touching the ear with the dropper tip. Keep head tilted for about 5 minutes to help the drops stay in the ear canal. A small piece of cotton may be gently inserted at the ear opening to prevent the solution from running out. Replace the cotton at least once a day. Do not use more, or more often than recommended.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.
What may interact with this medicine?
Interactions are not expected. Do not use any other ear products without asking your doctor or health care professional.
What should I watch for while using this medicine?
This medicine is not for long-term use. Do not use for more than one week without checking with your doctor or health care professional. Do not use if there is any discharge from the ear. Contact your doctor or health care professional if your condition does not start to get better within a few days or if you notice burning, redness, itching or swelling.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
