Our Philadelphia Orabase drug injury lawyers offer representation to people injured by Orabase oral pain products. Orabase is a non-prescription (over-the-counter, or OTC) medication manufactured by Colgate Oral Pharmaceuticals, Inc. to treat mouth and gum pain in adults, babies / infants, and children. Orabase oral pain drugs, which contain benzocaine, have been linked to a severe and sometimes fatal condition called methemoglobinemia.
Methemoglobinemia leads to a life-threatening decrease in oxygen levels in the blood brought on by the ingestion (swallowing) of benzocaine. Signs, symptoms, and effects of methemoglobinemia in adults, infants, or children can include:
- pale skin and / or changes in skin color (blue or gray)
- increased heartrate
- head pain
- shortness of breath
Symptoms of methemoglobinemia can become apparent within hours or even minutes of the first use of Orabase or another benzocaine oral product, according to the U.S. Food & Drug Administration (FDA).
Orabase and other Benzocaine Oral Products that May Result in Methemoglobinemia
Orabase and other oral benzocaine products are designed to numb pain or discomfort caused by teething, canker sores, dentures, and other mouth injuries. The medications / drugs are sold as:
- sprays, and
Orabase products that may lead to the development of methemoglobinemia include:
- Colgate Orabase Maximum Strength Oral Pain Reliever (Canker and Mouth Sores)
- Orabase-B Gel
- Orabase Protective Paste for Mouth and Stoma Care
- Orabase Soothe-N-Seal Liquid
- Orabase Gel
Additional benzocaine products that may cause methemoglobinemia include:
- Anbesol products
- Orajel products (see Philadephia Orajel / Baby Orajel Drug Injury Lawyers)
- HurriCaine products
For more information on benzocaine products and methemoglobinemia, see Philadelphia Benzocaine Drug Injury Lawyers.
Orabase FDA Warnings
In 2006, the FDA warned that using Orabase or other oral benzocaine pain numbing products poses a serious risk of methemoglobinemia. The FDA issued additional warnings in 2011 of the serious and potentially fatal side effect from OTC benzocaine gels and liquids used on the mouth or gums and from sprays used in medical procedures.
On May 23, 2018, the FDA released a safety announcement informing of the risk of a “serious and potentially fatal blood disorder” (methemoglobinemia) from Orabase and other benzocaine oral products. The FDA warned parents and caregivers to cease using Orabase and other benzocaine products on infants and children below two years of age. The agency also:
- warned consumers of the dangers of using these products on adults and children over the age of two without specific label warnings and product instructions related to the risk and effects of methemoglobinemia from benzocaine oral products, and
- cautioned manufacturers of Orabase and other benzocaine-containing products that benzocaine products will be removed from the market unless manufacturers stop marketing them for use by children under two
Lawsuits brought by Philadelphia Orabase drug injury lawyers may allege that Orabase manufacturer Colgate Oral Pharmaceuticals, Inc.:
- designed and manufactured a defective / unreasonably dangerous drug / medication
- made deceptive claims about the safety and effectiveness of Orabase products
- failed to provide consumers with adequate warnings of the risks of adverse side effects from Orabase use
- caused methemoglobinemia and resultant serious injury and / or death to Orabase users
Contact our Philadelphia Orabase Drug Injury Lawyers
Orabase oral pain products can lead to serious illness or death in babies, children, and adults. If you or a loved one developed methemoglobinemia after using Orabase for mouth or gum pain, you may be entitled to compensation through legal action. Contact our Philadelphia Orabase drug injury lawyers, today, for a free evaluation of your case.