Benzocaine, the active ingredient in Orajel and many other topical oral pain relievers, has been linked to methemoglobinemia, a life-threatening disorder that causes oxygen levels in the blood to drop.
Benzocaine is a topical local anesthetic used to relieve pain and/or itching caused by teething, poison ivy, minor burns, and more. It is sold over-the-counter (OTC) in the form of ointments, sprays, gels, creams, and lozenges.
Benzocain blocks nerve signals that cause pain when applied to the skin or gums.
Side effects associated with the use of benzocaine may include:
Benzocaine is the active ingredient in many OTC drugs used to relieve mouth, gum, and teething pain, including:
In May 2018, the FDA urged the manufacturers of Orajel and and other OTC benzocaine-based teething remedies to stop marketing their products for use in children under 2 because of a potential association with methemoglobinemia. The agency also requested that the makers of other benzocaine-containing oral medications modify their product labels to warn of this potential risk.
Parents and caregivers have been advised not to administer benzocaine-based teething remedies to children under the age of 2.
“We have been closely monitoring the risk of methemoglobinemia with the use of OTC and prescription local anesthetics and previously communicated about this risk in 2014, 2011, and 2006,” the FDA stated in a Drug Safety Communication dated May 23, 2018. “We estimate that more than 400 cases of benzocaine-associated methemoglobinemia have been reported to FDA* or published in the medical literature since 1971. There are likely additional cases about which we are unaware.”
Methemoglobinemia is a dangerous condition that causes blood oxygen levels to drop significantly. The disorder can lead to death if not treated in a timely manner.
Methemoglobinemia can either be congenital – present at birth – or it may be acquired following exposure to certain drugs, chemicals, or foods. Babies are especially susceptible to acquired methemoglobinemia.
Initial symptoms of acquired methemoglobinemia may include:
As the condition progresses, patients may experience:
Methylene blue is used to treat severe cases of methemoglobinemia. Doctors may also prescribe ascorbic acid to reduce the level of methemoglobin in the blood.
People with severe methemoglobinemia may require a blood transfusion or exchange transfusion. Oxygen therapy might also be needed.
Get the latest news and litigation updates about this case by following us on Facebook. Click the "Like" button below.