FDA Demands Baby Orajel be Taken Off the Market

Recently, the Food and Drug Administration said that companies and other oral health care product providers must stop selling Baby Orajel. This post provides some information about this recent announcement and what parents need to know about it.

What is Baby Orajel?

Baby Orajel is one of many teething creams and gels that uses a popular numbing agent known as benzocaine. The product provides temporary relief of sore gums due to teething in infants and children. Baby Orajel is not the only product on the market using benzocaine as an active oral numbing agent. Other brands include Anbesol, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel, and Topex, as well as store brands and generics containing benzocaine as well.

Why Has Baby Orajel Been Recalled?

While rare, benzocaine has been known to cause deadly side effects in children, especially those under the age of 2. One such condition is methemoglobinemia, which results in elevated levels of methemoglobin in the blood causing the amount of oxygen carried through the blood to be greatly reduced. More than 400 cases of methemoglobinemia resulting from benzocaine have been reported to the Food and Drug Administration since 1971, and since 2006 the Food and Drug Administration has received 29 reports of benzocaine gel-related cases of methemoglobinemia, 19 of which occurred in children and 15 of which occurred in children under the age of 2.

Further, in making the announcement, the Food and Drug Administration stated that it found that there was a lack of efficacy of using benzocaine for teething infants, which contributed to its decision to direct companies and sellers of over-the-counter oral health products containing benzocaine to stop producing and selling the product. The Food and Drug Administration said that the products are not useful for treating sore gums resulting from teething because they wash out of a baby’s mouth within minutes of application.

Are These Risks New?

This is not the first time the Food and Drug Administration has warned about the issues associated with the use of benzocaine. In 2006 and 2011, the Food and Drug Administration warned about the potential dangers associated with benzocaine and has also previously stated that parents should not use products containing the ingredient in children under the age of 2.

What Are Symptoms of Methemoglobinemia?

According to the Food and Drug Administration, 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 symptoms can occur minutes to hours after benzocaine use, and can occur whether it is the first time the benzocaine has been used, or after several uses. If a child has any of these symptoms after using benzocaine, immediate medical attention should be sought by calling 911.

Has Your Child Been Affected by Baby Orajel?

If you used Baby Orajel on your child and your child suffered any of the symptoms associated with methemoglobinemia, contact the experienced attorneys at Scaffidi & Associates today. You and your child deserve safe products that will help them grow into happy, healthy, children who lead a full life. The personal injury attorneys at Scaffidi & Associates have extensive experience and knowledge of products liability issues, and they will help you determine your options.

Posted in: Personal Injury Law


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