The FDA recently issued a warning to the public about the use of over-the-counter products containing benzocaine, a local anesthetic used to relieve pain in the mouth and gums. The product is commonly used for pain associated with teething, canker sores, and irritation of the mouth and gums. The FDA became concerned about products containing benzocaine because they may cause a rare but serious and possibly fatal condition where oxygen in the blood stream is greatly reduced. This condition is called methemoglobinemia. In the most serious cases, this condition can result in death. Benzocaine products do not currently carry any warnings regarding methemoglobinemia, therefore, the FDA is concerned that consumers might not be aware of the danger or know what to look for when using these products.
Signs and symptoms of methemoglobinemia include pale, gray or blue colored skin, lips and nail beds, shortness of breath, fatigue, confusion, headache, lightheadedness, and rapid heart rate. The FDA is particularly concerned about the use of benzocaine products in children under two years of age. There have been 21 reported cases of methemoglobinemia after using benzocaine gels and liquids. Eleven of the 21 cases occurred in children under age two.
If while using benzocaine products any of the symptoms of methemoglobinemia appear, persons should stop using the product immediately and call 911. If left untreated, serious cases may lead to permanent injury to the brain and body tissues, and even death. Parents are cautioned not to use this product on children less than two years of age unless it is given under the advice and supervision of a healthcare professional. These products should always be kept out of reach of children. The American Academy of Pediatrics recommends that for teething problems in children, safer alternatives such as chilled teething rings or gentle massage to the gums using a cloth or your finger are preferred over benzocaine products. For a list of products containing benzocaine, visit the FDA’s website. If you need additional information, contact Danielle Mason, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Danielle.Mason@beasleyallen.com.
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