Our Philadelphia Orajel / Baby Orajel drug injury lawyers offer representation to adults, infants, and children who have suffered serious injury or death due to use of Orajel or Baby Orajel products. Orajel and Baby Orajel medications are gels, liquids, and other substances sold without a prescription (also known as over-the-counter, or OTC) to numb or lessen tooth, gum, and other mouth pain from:

  • teething
  • canker sores
  • toothache
  • dentures
  • other oral conditions

Orajel and Baby Orajel (manufactured and marketed by Church & Dwight Co.) have been linked to serious injury and death. Benzocaine, an ingredient contained in all Orajel and Baby Orajel products, can cause a life-threatening and sometimes fatal condition called methemoglobinemia. It does so by raising the level of methemoglobin in a product user’s blood, which leads to a serious drop in blood oxygen levels.

According to the U.S. Food & Drug Administration (FDA), oral benzocaine products such as Orajel and Baby Orajel provide little to no effectiveness in reducing mouth pain and create a significant risk of methemoglobinemia. The FDA considers the risk so severe that it:

  • urged manufacturers of Orajel, Baby Orajel, and other oral benzocaine products to cease marketing these products for use by children under two years of age, and
  • warned that it would take action to remove the products from the marketplace if manufacturers do not comply with the FDA’s request

Symptoms of Benzocaine-induced Methemoglobinemia

Symptoms of methemoglobinemia caused by Orajel, Baby Orajel, and other benzocaine products can occur after the first use of a product and appear within minutes or a few hours, according to the FDA. Methemoglobinemia signs, symptoms, and effects can include:

  • pale, gray or blue tinted lips, skin, and nail beds
  • fatigue and confusion
  • lightheadedness
  • headache
  • rapid heartbeat
  • shortness of breath
  • seizures
  • coma
  • death

Orajel and Baby Orajel Benzocaine Products

Orajel and Baby Orajel benzocaine-containing products that may cause methemoglobinemia have been sold under a variety of names, including:

  • Baby Orajel
  • Baby Orajel Medicated Daytime & Nighttime Teething Twin Pack
  • Baby Orajel Medicated Teething Gel
  • Baby Orajel Medicated Nighttime Teething Gel
  • Baby Orajel Medicated Teething Swabs
  • Orajel Maximum Strength
  • Orajel Medicated Toothache
  • Orajel Mouth Sore
  • Orajel PM
  • Orajel Ultra Mouth Sore
  • Orajel Denture Plus

Other Benzocaine Oral Pain Products

In addition to Orajel and Baby Orajel products, benzocaine oral pain medications that may cause methemoglobinemia include:

  • Anbesol
  • Anethesin
  • Cepacol
  • Cetacaine
  • Chloraseptic
  • HurriCaine Topical Anesthetic Gel
  • HurriCaine Gel
  • Lanacane
  • Orabase (see Philadelphia Orabase Drug Injury Lawyers)
  • Topex

See also Philadelphia Benzocaine Drug Injury Lawyers.

Orajel and Baby Orajel FDA Warnings

As early as 2006, the FDA issued warnings about the risk of methemoglobinemia from use of Orajel, Baby Orajel, and other products containing benzocaine. Five years later, in 2011, the FDA again issued a warning about the potentially fatal adverse effect linked to benzocaine oral products applied to the mouth or gums or used by health care providers during certain medical procedures.

The FDA further strengthened its warnings on May 23, 2018, cautioning parents and caregivers to never use Baby Orajel, Orajel, or other benzocaine oral products on children under the age of two. The FDA also stated that Orajel and other benzocaine products should not be used by adults or children over the age of two unless the products:

  • contain specific label warnings about the risk of methemoglobinemia with use of Baby Orajel, Orajel, and other benzocaine-containing oral products
  • contain label warnings as well as instructions / directions to parents not to use the products for children under two

Orajel and Baby Orajel Lawsuits

Lawsuits commenced by Philadelphia Orajel / Baby Orajel drug injury lawyers may allege that Orajel product manufacturer and marketer Church & Dwight Co.:

  • manufactured products that are unreasonably dangerous to infants, children, and adults who use them
  • misrepresented the effectiveness and safety of Orajel and Baby Orajel products
  • failed to provide adequate information and warnings to consumers about the dangers of Orajel and Baby Orajel products
  • caused serious injury to Orajel product users

Contact our Philadelphia Orajel / Baby Orajel Drug Injury Lawyers

Orajel benzocaine mouth pain products can cause severe injury and death. If you or one of your family members developed methemoglobinemia after use of an Orajel or Baby Orajel product, our Philadelphia Orajel / Baby Orajel drug injury lawyers can help you obtain the justice you deserve. Contact us, today, for a cost-free evaluation of your case.