There’s a warning for parents of babies that are teething.

The Food and Drug Administration has issued a warning about benzocaine. That’s the numbing medication normally used in gel and liquid over-the-counter products like Anbesol and Baby Orajel.

Benzocaine has been linked to a rare condition called methemoglobinemia. That’s when the blood does not move oxygen through the body.

In the very worst cases it can be deadly.

The FDA is advising parents not to use products with benzocaine on kids under two, unless advised by a doctor.

THE FOLLOWING IS FROM THE FDA:

The U.S. Food and Drug Administration (FDA) is warning the public that the use of benzocaine, the main ingredient in over-the-counter (OTC) gels and liquids applied to the gums or mouth to reduce pain, is associated with a rare, but serious condition. This condition is called methemoglobinemia and results in the amount of oxygen carried through the blood stream being greatly reduced. In the most severe cases, methemoglobinemia can result in death.

Benzocaine gels and liquids are sold OTC under different brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands. Benzocaine is also sold in other forms such as lozenges and spray solutions. These products are used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, including concentrations as low as 7.5%. The cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. People who develop methemoglobinemia may experience pale, gray or blue colored skin, lips, and nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; and rapid heart rate.  In some cases, symptoms of methemoglobinemia may not always be evident or attributed to the condition. 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. If you or your child has any of these symptoms after taking benzocaine, seek medical attention immediately.

Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional. Healthcare professionals and consumers are advised to consider the American Academy of Pediatrics’ recommendations for treating teething pain instead of using the benzocaine teething products:

• Give the child a teething ring chilled in the refrigerator.
• Gently rub or massage the child’s gums with your finger to relieve the symptoms of teething in children.

If these methods do not provide relief from teething pain, consumers should talk to a healthcare professional to identify other treatments.

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.

Additional Information for Consumers and Caregivers

• Labels of marketed benzocaine products currently do not as of yet contain warnings about the risk of methemoglobinemia, even though the use of benzocaine can cause this serious condition.  
• Benzocaine products should not be used on children less than two (2) years of age, except under the advice and supervision of a healthcare professional.
• Store benzocaine products out of reach of children.
• If benzocaine products are used, watch for signs and symptoms of methemoglobinemia, including pale, gray or blue colored skin, lips, and nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; and rapid heart rate. If you or your child has any of these symptoms after taking benzocaine, seek medical attention immediately.
• Signs and symptoms of methemoglobinemia may appear within minutes to one or two hours after using benzocaine. Symptoms may occur after using benzocaine for the first time, as well as after several uses.
• The development of methemoglobinemia after treatment with benzocaine gels and liquids has been reported to occur following a single administration of the product.
• Benzocaine gels and liquids should be used sparingly and only when needed, but not more than four (4) times a day. If pain persists despite using the product as labeled, contact your healthcare professional for further evaluation and treatment recommendations.
• Report side effects or medication errors from the use of benzocaine to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

Additional Information for Healthcare Professionals

• Labels of marketed benzocaine products currently do not as of yet contain warnings about methemoglobinemia, although the use of benzocaine can cause this condition.    
• Advise patients and caregivers to use the smallest amount possible to relieve pain and not to apply the product more frequently than four (4) times daily.
• Before recommending benzocaine products, discuss the signs and symptoms of methemoglobinemia with your patients. Advise patients to monitor for signs and symptoms when using benzocaine products, and to seek medical attention immediately if they suspect methemoglobinemia.
• Recognize the signs and symptoms of methemoglobinemia, including pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and tachycardia. These indicate a moderate to severe level of methemoglobin and a marked reduction in the oxygen-carrying capacity of the blood. A characteristic color of the blood (chocolate-brown rather than blood red) may indicate methemoglobinemia, but this change is a late sign of the condition. 
• Symptoms may appear within minutes to one or two hours after using benzocaine. Symptoms may occur with the first or subsequent applications of benzocaine.
• Methemoglobinemia can cause unreliable oxygen saturation readings on a standard 2-wavelength pulse oximeter when used to assess the amount of oxygen bound to hemoglobin. If blood is drawn to check for methemoglobinemia, an FDA approved co-oximeter should be used to reliably measure methemoglobin. 
• Patients who have breathing problems such as asthma, bronchitis, or emphysema, patients with heart disease, and patients who smoke are at greater risk for complications related to methemoglobinemia.
• Infants less than four months of age, elderly patients, and patients with certain inborn defects such as glucose-6-phosphodiesterase deficiency, hemoglobin-M disease, NADH-methemoglobin reductase (diaphorase 1) deficiency, and pyruvate-kinase deficiency may also be at greater risk of developing methemoglobinemia.
• Medications, foods, and water containing nitrites and nitrates may also induce methemoglobin formation that will be additive to that formed by benzocaine products.^{3, 4}
• Report adverse events or medication errors involving benzocaine to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of this page.

FDA will continue to evaluate this safety issue and will take appropriate regulatory actions as warranted.

(YWN Desk – NYC)