Weitz & Luxenberg is now accepting cases of infants, children, and adults harmed by over-the-counter (OTC) products containing benzocaine, typically used for teething and mouth pain, following a warning by the U.S. Food & Drug Administration (FDA).

On May 23, 2018, the FDA released a safety alert about the dangers of OTC benzocaine products, advising that they could cause a serious and potentially fatal blood condition, methemoglobinemia, and urging manufacturers to cease marketing of these products for children and infants younger than two.

Marketed Relief from Teething Pain and Mouth Pain

Benzocaine products used for teething are topical anesthetics that are often used in an attempt to temporarily numb pain associated with teething or toothaches, and provide relief for sore or irritated gums. Common OTC benzocaine products are Anbesol, Hurricaine, Orajel, Baby Orajel, Cetacaine, and Orabase. These products come in a variety of forms, including gels, sprays, ointments, solutions, and lozenges.

“Significant Safety Risk” with OTC Benzocaine Products

In its May 2018 safety alert, the FDA warned that OTC benzocaine products should not be used to treat infants and children younger than two years old because of a “significant safety risk.” The FDA warned these benzocaine-containing products can cause a condition called methemoglobinemia, which reduces the amount of oxygen in the blood and can be life-threatening or result in death.

In its warning, the FDA said that OTC benzocaine products provide few benefits to babies suffering from teething pain and cautioned use for adults and children over two, as well.

The FDA also notified the public of over 400 cases of methemoglobinemia occurring in people who had used benzocaine-containing products that have been reported to the agency via the FDA Adverse Event Reporting System (FAERS), or published in the medical literature since 1971.

FDA Urges Manufacturers to Stop Marketing OTC Benzocaine Products for Infants and Children, Add Warnings for Adult Use

Because of the serious health issues caused by these products, the FDA urged manufacturers to stop marketing OTC benzocaine products for infants and children younger than two. The agency warned that it will take action to remove the products marketed for babies and toddlers from shelves if companies do not take steps to cease marketing these products for children younger than two and add additional safety warnings to their labels.

The agency also recommended that product labels be updated to better alert adults and parents of children over the age of two about the risk of developing methemoglobinemia after using OTC benzocaine products.

Symptoms Associated with the Blood Condition Caused by Orally Ingested Benzocaine

The signs and symptoms associated with methemoglobinemia vary but can include discoloration of the skin and blood. In some cases, the blood turns a chocolate-brown color or patients may develop cyanosis, which is a bluish color of the skin, especially the lips and fingers. Other signs of the condition are shortness of breath, fatigue, headache, fast heart rate, and confusion. Patients may suffer seizures, coma, or death.

W&L Can Help Families Harmed by OTC Benzocaine Teething and Mouth Pain Products

Weitz & Luxenberg’s Drug and Medical Device Litigation Practice Group Co-Chair Ellen Relkin says the firm is interested in hearing from anyone whose child or infant was diagnosed with methemoglobinemia and was subsequently hospitalized or died after using an OTC benzocaine teething product, or adults who have used benzocaine products for mouth pain who developed methemoglobinemia and were hospitalized or died as a result of the use of these products.

Ms. Relkin has played a leading role in several major dangerous drug litigations and represented
families and children who suffered strokes after taking OTC cold medicines with phenylpropanolamine (PPA), a decongestant that was widely used until it was removed from the market.

“Far too often, we find that powerful and dangerous drugs are easily available over the counter with little indication to parents that they can cause significant health problems for their children,” said Ms. Relkin. “Just as with previous litigation over cold medicines containing PPA, these companies have known for years about the risks associated with their teething and oral pain products but continued to sell them. We must take action to prevent more people from being harmed and help those who have already suffered.”

Weitz & Luxenberg is ready to assist you, beginning with a free consultation. Contact us at (800) 476-6070 or by using the online form on this page to discuss your legal options.

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