Our Philadelphia benzocaine drug injury lawyers are evaluating cases from people who suffered serious injuries after using over-the-counter (OTC) oral benzocaine products for toothache, canker sore, teething, and other gum and mouth pain. Benzocaine is a local topical anesthetic (substance used to numb a particular part of the body) contained in many non-prescription / OTC products for relief of mouth pain in children, infants / babies, and adults.

Benzocaine OTC oral pain products have been associated with a serious and sometimes deadly condition known as methemoglobinemia, which leads to a dangerous lowering of oxygen levels in the blood. The reduction in blood oxygen is caused by an increased amount of methemoglobin in the blood. Methemoglobinemia may result in:

  • gray, abnormally pale, or bluish skin, lips, and / or nail beds
  • confusion
  • lightheadedness and shortness of breath
  • rapid heartbeat
  • unusual fatigue
  • headache
  • seizures
  • coma
  • death

According to a U.S. Food & Drug Administration (FDA) pharmacist, symptoms of methemoglobinemia can occur within minutes to hours after use and can occur after the very first use of a benzocaine drug.

These products come in several forms, including gels, ointments, liquids, lozenges, and sprays. Users of all forms and strengths of benzocaine pain products have been diagnosed with methemoglobinemia. Oral benzocaine products that may lead to methemoglobinemia include:

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

FDA Benzocaine Warnings

Beginning in 2006, the U.S. Food and Drug Administration (FDA) warned about the potential danger of methemoglobinemia from use of benzocaine products. On April 7, 2011, the FDA issued updated FDA Drug Safety Communications about the dangerous methemoglobinemia side effect of benzocaine. The 2011 warnings stated that the FDA had received and continued to receive reports of a “rare, but serious and potentially fatal adverse effect” with the use of:

  • over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth, and
  • benzocaine sprays for medical procedures

On May 23, 2018, the FDA issued another updated warning that significantly strengthened the earlier cautions. The May 2018 warning states that oral OTC benzocaine products “should not” be used to treat infants and children younger than 2 years old and “should only” be used for adults and children older than 2 years of age if manufacturers:

  • change product labels to add warnings about methemoglobinemia
  • add contraindications to labels, warning parents not to use the products in children under 2, and
  • revise product directions to tell parents not to use the products in children under 2

After noting that these products do little or nothing to ease oral pain, the FDA announced:

“Due to the significant safety risk of methemoglobinemia, we have urged manufacturers that they should stop marketing OTC oral drug products for treating teething in infants and children younger than 2 years. If companies do not comply, we will take action to remove these products from the market.”

Benzocaine Oral Numbing Product Lawsuits

Lawsuits commenced by Philadelphia benzocaine drug injury lawyers may allege that the manufacturers of oral benzocaine numbing gels and other products:

  • produced, distributed, and marketed unreasonably dangerous products
  • misrepresented the safety of these products
  • failed to warn consumers about the severe dangers associated with these products
  • caused serious injury and death to users of these products

Contact our Philadelphia Benzocaine Drug Injury Lawyers

If you or your child sustained serious injury or death from methemoglobinemia after using a benzocaine over-the-counter (OTC) oral pain numbing product, let us help you obtain the justice you deserve. Contact our Philadelphia benzocaine drug injury lawyers, today, for a free evaluation of your case.