Benzocaine Lawsuit

A benzocaine lawsuit may be an option if you or someone you love was diagnosed with methemoglobinemia following administration of Orajel or another benzocaine-based oral pain medication.

Contact a Benzocaine Lawyer Today

Bernstein Liebhard LLP is investigating legal claims on behalf of individuals who were diagnosed with methemoglobinemia following treatment with an over-the-counter benzocaine medication. To contact an experienced benzocaine attorney for a free legal review, please call (888) 994-5118.

FDA Warning for OTC Benzocaine Medications

Benzocaine is the active ingredient in many drugs used to treat mouth pain, including the following OTC remedies:

  • Anbesol and Baby Anbesol
  • Benzodent
  • Cepacol Lozenges
  • Cetacaine
  • Exactacain
  • HurriCaine
  • Instant Pain Relief Maximum Strength
  • Orabase
  • Orabrite Oral Pain Reliever
  • Orajel and Baby Orajel
  • Topex
  • Dozens of store-brand medications

In May 2016, the U.S. Food & Drug Administration (FDA) asked the manufacturers of benzocaine-based teething medications to stop marketing the products for use in children under the age of 2, after benzocaine was linked to hundreds of cases of methemoglobinemia, a potentially deadly blood disorder.

The agency also asked the makers of other benzocaine-containing oral pain medications to modify their product labels to warn of this potential risk.

“We estimate that more than 400 cases of benzocaine-associated methemoglobinemia have been reported to FDA* or published in the medical literature since 1971,” the FDA state. “There are likely additional cases about which we are unaware.”

What is Methemoglobinemia?

People with methemoglobinemia experience a dangerous drop in blood oxygen levels. The potentially life-threatening disorder can be triggered by certain medications, toxins, and foods.

Babies are especially susceptible to methemoglobinemia. Patients who have breathing problems such as asthma, bronchitis, or emphysema; heart disease; the elderly; and those who smoke are at greater risk for complications if they develop the disorder.

Signs and Symptoms of Methemoglobinemia

Early methemoglobinemia symptoms may include:

  • Cyanosis (a bluish color in the skin, especially the lips and fingers)
  • Chocolate-brown colored blood

As their condition worsens, patients may experience:

  • Headache
  • Shortness of breath
  • Nausea
  • Rapid heart rate
  • Fatigue and lethargy
  • Confusion or stupor
  • Loss of consciousness

Signs and symptoms of methemoglobinemia may appear within minutes to one to two hours after exposure to benzocaine. Symptoms may occur after using benzocaine for the first time, as well as after prior uses.

Without timely treatment, severe methemoglobinemia can result in death.

What Should Parents and Caregivers Do?

According to the FDA:

  • Benzocaine or other local anesthetics should not be used to treat teething pain in infants and children under the age of 2.
  • Over-the-counter (OTC) benzocaine products should be used sparingly and only as needed in adults and children 2 years and older. Do not use the product more than four times a day.
  • People using benzocaine products to treat mouth pain should seek medical attention immediately if they experience any signs and symptoms of methemoglobinemia.

Learn More About Filing a Benzocaine Lawsuit

You may be entitled to compensation if you or someone you love were diagnosed with methemoglobinemia following exposure to a benzocaine-based oral pain medication. To learn more about filing a benzocaine lawsuit, please call (888) 994-5118.

  1. FDA (2018) “FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit” https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325.htm
  2. FDA (2018)” Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics” https://www.fda.gov/Drugs/DrugSafety/ucm608265.htm
  3. MedicalNewsToday (2017) “What is methemoglobinemia?” https://www.medicalnewstoday.com/articles/320396.php
Last Modified: August 8, 2018

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