Orajel Dangerous to Children Warns FDA

Orajel Lawsuit News

FDA Issues Orajel WarningThe FDA issued a warning about benzocaine, the active ingredient in oral pain medications such as Orajel on April 7, 2011. The FDA warns that benzocaine use has the potential to induce a potentially fatal side effect whereby the blood carries significantly lower amounts of oxygen. This condition, known as methemoglobinemia, can in rare cases cause death or brain injury and damage to the body tissues. The potential for life-threatening or long-term damages from methemoglobinemia due to benzocaine is further compounded in very young children.

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Benzocaine products do not currently contain warnings of methemoglobinemia, which the FDA stated as a grave cause for concern since consumers, parents and caregivers are in most likelihood not aware of this potential side effect and as such very unlikely to be monitoring for the possible side effect. Methemoglobinemia induced by benzocaine use may require treatment with medications and/or admission to a hospital. The FDA recommends that anyone experiencing pale, gray or blue colored skin lips and/or nail beds, shortness of breath, fatigue, confusion, headache, lightheadedness or rapid heartbeat after taking a medication with benzocaine such as Orajel immediately call 911. Benzocaine-induced methemoglobinemia may occur after the first application or even after using the medication multiple times without incident.

The following Orajel products were listed in the FDA Benzocaine Warning for Liquid and gel over the counter medications containing benzocaine:

  • Baby Orajel
  • Baby Orajel PM
  • Orajel Maximum Strenth
  • Orajel Medicated Toothache
  • Orajel Mouth Sore
  • Orajel PM
  • Orajel Ultra Mouth Sore
  • Orajel Denture Plus

Orajel Side Effects

The FDA has warned of potential fatal side effects from Orajel usage, all stemming from benzocaine-induced methemoglobinemia, but even side effects that are not fatal may have life-long debilitating consequences should the brain and organs become oxygen-starved for a prolonged period, such as delayed brain development, seizures and even mental retardation.

Initial symptoms of Orajel methemoglobinemia may include the following:

  • Decreased Alertness
  • Fatigue or Lack of Energy
  • Increased Salivation
  • Loss of Conciousness
  • Convulsions
  • Cyanosis - Skin, Lips and Fingernails May Turn Blue (see Blue Baby Syndrome below)

The initial symptoms may seem to indicate that the Orajel medication is working, providing a teething child with relief after hours of crying, when it is possible that a life-threatening event is taking place. This, coupled with the fact that most parents are completely unaware that this danger from using Orajel exists has created what the FDA calls "grave cause for concern". In adults, these symptoms will also include headache, rapid heart rate and shortness breath, which give a much greater indicator that something has gone wrong and the user is experiencing severe Orajel side effects that require immediate medical attention.

Orajel Lawsuits from Injury to Children

Baby Orajel WarningMethemeoglobinemia is often referred to as "blue baby syndrome" when it occurs in infants, due to the fact that the baby may have a blue tint to the skin as oxygen is deprived. The FDA Benzocaine Warning specifically referenced the dangers of using products containing benzocaine, such as Baby Orajel, for teething in children of ages two and younger. Eleven of the 21 deaths reported after using an OTC benzocaine gel or liquid were children just two years old or less, who were given the benzocaine medication for teething. The FDA has recommended that OTC medications containing benzocaine, such as Baby Orajel, not be given to children under the age of two except under the advice and supervision of a healthcare professional. The FDA also warns that methomoglobinemia symptoms may not always be evident and even if the child has not had a reaction to previous benzocaine uses, this life-threatening condition could still occur after subsequent dosages. Methemoglobinemia after using a product with benzocaine can also occur in adults.

Deaths Attributed to SIDS May Have Been Benzocaine Induced Methemoglobinemia

Medical studies have questioned if methemoglobinemia deaths were being attributed to other causes since the mid-1980's. Methemoglobin levels are known to rise after death, and thus elevated methemoglobin levels have been ingnored in many cases. A 2005 death of an infant was attributed to SIDS but later determined to be methemoglobinemia induced by an over the counter benzocaine-based medication.

Orajel Lawsuit Options - Orajel Lawsuit Information

If you or a loved one believes you may have suffered from methemoglobinemia after using a benzocaine-based oral or liquid product such as Baby Orajel, Orajel Maximum Strenth, Orajel Medicated Toothache, Orajel Mouth Sore, Orajel PM, Orajel Ultra Mouth Sore or Orajel Denture Plus, please contact our lawyers handling Orajel and other benzocaine OTC medications cases. You have legal options and rights and we're here to help.

Orajel LawyersOnder, Shelton, O'Leary & Peterson, LLC is a law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. Onder, Shelton, O'Leary & Peterson has represented clients throughout the United States, and other firms throughout the nation often seek its experience and expertise on complex litigation. The Onder Law Firm is a recognized leader in window blind cord strangulation and vigorously litigates those and other child safety cases in an effort to force manufacturers of dangerous products to improve their safety standards. The Onder Law Firm represents cases such as Orajel methemoglobinemia on a contingency basis.


Other Over the Counter Medications with Benzocaine That May Be Dangerous to Children
  • Americaine
  • Americaine Hemorrhoidal
  • Anbesol
  • Anbesol Baby
  • Anbesol Cold Sore Therapy
  • Anbesol Jr.
  • Anbesol Maximum Strength
  • Banadyne
  • Benzocaine Burn Spray
  • Benzodent
  • Boil Ease Maximum Strength
  • Cepacol Sore Throat
  • Cetacaine
  • Chiggerex
  • Comfort Caine
  • Dentapaine
  • Dent’s Extra Strength Toothache
  • Dent’s Maxi-Strength Toothache
  • Dermoplast Antibacterial
  • Dermoplast Painrelieving
  • Detane
  • Dry Socket Remedy
  • Exactacain
  • Foille
  • Freez Eez
  • HDA Toothache
  • Hurricaine
  • Ivy-Rid
  • Kanka Soft Brush
  • Lanacane
  • Lanacane Maximum Strength
  • Mycinettes
  • Navogan
  • Orabase with Benzocaine
  • Oticaine
  • Otocain
  • Outgro
  • Red Cross Canker Sore
  • Rid-A-Pain Dental Drops
  • Skeeter Stik
  • Sting-Kill
  • Tanac
  • Thorets
  • Topicale Xtra
  • Trocaine
  • Walgreens Oral Anesthetic Paste
  • Walgreens Zilactin-B
  • Zilactin Toothache and Gum Pain