The U.S. Food & Drug Administration (FDA) just issued a warning on some teething gels. These topical gels are frequently rubbed on the gums to help teething pain in infants and toddlers. It has been found that these teething gels can lead to a serious condition called methemoglobinemia that can lead to oxygen deprivation and even death.
Methemoglobinemia is a blood disorder where there is an abnormal amount of methemoglobin, a form of hemoglobin, in the blood. Hemoglobin is responsible for carrying oxygen to the rest of the body. If there is too much methemoglobin or methemoglobinemia, the hemoglobin is unable to release the oxygen and it could result in tissue or brain hypoxia.
The FDA warning is related to any of the over-the-counter (OTC) toothache or teething medications that contain benzocaine. Even though adults also use these topical gels for tooth pain, the risk is most significant in children under the age of two, which is when most of the teething process is taking place. To date, the FDA has received 29 reports of known benzocaine gel-related cases of methemoglobinemia with 19 of those cases occurring in children and 15 cases in children under 2 years of age.
Since these medications are over-the-counter the concern is that consumers or parents may not be able to recognize the signs and symptoms of methemoglobinemia. Symptoms can include pale, gray or blue colored (cyanotic) skin, lips or nail beds, shortness of breath, fatigue, lethargy, confusion, headache, light-headedness and a rapid heart rate. An arterial blood gas would have a chocolate-brown color instead of the normal bright red, oxygen rich, blood color.
If methemoglobinemia is diagnosed it must be treated right away with oxygen administration and methylene blue 1% solution. The Methylene blue helps to restore the iron in the hemoglobin to it's normal oxygen-carrying state. Any failure in a delay in diagnosing and treating methemoglobinemia can lead to permanent brain damage or even death.
The FDA is advising consumers and parents to not use OTC benzocaine teething products on children under the age of 2 except under the advice and supervision of a healthcare professional. If a benzocaine product is used, it must be used sparingly and not more than four times a day. The American Academy of Pediatrics (AAP) recommends using chilled teething rings or gently massage the baby's gum with your finger instead of using OTC benzocaine products. For a list of OTC benzocaine products you can visit the FDA's web site.
If you or your baby was injured due to OTC tooth pain or teething gel medications please feel free to contact one of our experienced dangerous drug lawyers, doctors or nurses at (215) 866-2424 for a strictly confidential and free consultation. Our nationally recognized pharmaceutical error attorneys at The Beasley Firm have successfully fought for individuals who have sustained illness or injury because of dangerous drugs. We have successfully obtained dozens of six, seven, and even eight figure settlements and verdicts on behalf of injured clients.