FDA: Baby Orajel (Benzocaine) Causes Fatal Blood Disease

March 23, 2018:  The Federal Drug Administration (FDA) released a new warning regarding Benzocaine (also known as Orajel, Baby Orajel, Anbesol, Hurricane and other brands) which are marketed as a pain reliever in teething babies:

[Benzocaine and Orajel products] carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething. Benzocaine, a local anesthetic, can cause a condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, can be life-threatening and result in death.

The FDA states these over the counter (OTC) medications should not be used by parents on children under 2 due to the serious – and sometimes fatal – risks. The FDA released previous warnings in 2011.

Baby Orajel

“Baby Orajel” is a Benzocaine OTC product found in stores all over the United States.  The product name and the image of a baby on the box demonstrate the company’s specific marketing of its product to children under 2 years old.  Baby Orajel was specifically listed in the FDA’s 2011 and 2018 warnings for causing methemoglobinemia and the 2018 warning against its use in children under 2 years of age.  The FDA language suggests the product may be removed from the market completely as this product and others are marketed specifically for use in infants and toddlers.

Benzocaine

Benzocaine is a painkiller, sold under the brand name Orajel, designed to be used locally on the affected skin or tissue to reduce pain. It can be found in other products such as ear drops designed to relieve ear pain, or in cough drops.

In baby products, it is used for its local anesthesia affect, however the FDA warns that the product is not useful as the effects wear off in the mouth quickly as the chemical is washed away by saliva.

Alternatives to Benzocaine include teething rings, which the FDA recommends be placed into a fridge to provide cooling relief. Parents can also simply rub or swab the gums without any product to offer their child relief from teething symptoms.

Infant Death from Baby Orajel Benzocaine

The FDA warns that Baby Orajel and other products may cause blood disease even if used once and even when used with low concentration formulas.  As stated in the FDA warning:

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.

What is Methemoglobinemia?

Methemoglobinemia is a blood disease diagnosed by the percentage of methemoglobin in the blood.  At high levels, methemoglobin can cause a reduction of oxygen carrying capacity in red blood cells, resulting in tissue hypoxia or lack of oxygen to tissue.

Symptoms of severe methemoglobinemia include seizures, coma and death. Symptoms may also include headache, fatigue, shortness of breath and dizziness. The FDA adds these additional warnings to monitor if Baby Orajel was used:

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.

Baby Orajel Injury Lawyer

Contact us for a free consultation. We will investigate any instance of infant injury caused by Orajel or other products. Reach us by calling us at (415) 426-3000, emailing info@levinsimes.com, or starting a web chat.

Additional Links:

• FDA 05/23/2018 Warning: Potentially Fatal Blood Disorder
• FDA 05/23/2018 Safety Announcement: FDA action on oral anesthesia
• FDA 04/07/2011 Safety Announcement: Baby Orajel causes fatal blood condition