Parents will generally use products with benzocaine to alleviate pain associated with growing teeth and sore gums in infants, toddlers, and children. Benzocaine is a topical anesthetic (numbing medication), which is the main ingredient in oral sprays, gels, and other products that help relieve canker sores, sore throats, and irritation of the mouth and gums. Until recently, it has been popular in over-the-counter medications used to treat pain associated with teething in infants. 

Orajel is one of the teething products that contain benzocaine. It works by blocking nerve signals in the body. When used to relieve teething pain, Orajel numbs the surfaces or skin inside the mouth. This product can also be used for temporary relief of sore gums resulting from sprouting teeth in children 2 years and older. However, the U.S. Food Drug Administration (FDA) has issued warnings against the used of these products in children below the 2 years. Adults have also been warned about the fatal side effect, methemoglobinemia, which is a life-threatening blood disorder that tends to reduce the amount of oxygen delivered to cells in the body.

Based on the FDA reports, infants are particularly vulnerable to the potential risks of Orajel. While benzocaine usually causes methemoglobinemia in cases involving a drug overdose, even small amounts of Orajel can be dangerous to infants. At least 4 individuals, including an infant, have died from methemoglobinemia following treatment with medications containing benzocaine.

Orajel and other benzocaine-based teething products have not only been found to be dangerous but ineffective because the medication can easily rinse out of the mouth before it even does what it’s intended to do. Children have limited abilities to communicate explain symptoms or discomfort, which makes it difficult to use these medications.

FDA Teething Warning

Twenty-seven years after Orajel was approved by the FDA as a mild, over-the-counter oral painkiller, the agency is reversing its stance. On May 23, 2018, the FDA issued a safety bulletin regarding over-the-counter benzocaine products used for mouth and teething pain. The bulletin also covered prescriptions local anesthetics such as chloroprocaine, bupivacaine, articaine, prilocaine, mepivacaine, tetracaine, and ropivacaine. In the warning against the use of OTC benzocaine teething products, the FDA cited serious safety concerns and a lack of effectiveness in relieve teething pain.

The FDA also noted that benzocaine products can cause methemoglobinemia. This warning is an update to a statement made by the agency in 2006. Back then, the agency had received 319 reports of methemoglobinemia, which shows that the FDA was well aware of this particular complication. These reports were not limited to children, and 72 of them occurred between 2006 and 2011. In that particular statement, the agency stated that it planned to monitor products made with benzocaine and would update advisories.

In 2011, the agency warned the consumers about benzocaine and its association with methemoglobinemia. Medical journals and FDA reports estimate that more than 400 cases of methemoglobinemia were related to Orajel since 1971. In 2016, the FDA issued another warning to parents and caregivers not to use teething gels or tablets to relieve pain. It was discovered that they posed an augmented risk of seizure, lethargy, breathing difficulties, flushed skin, muscle weakness, difficulty urinating, constipation, agitation, or excessive sleepiness. Homeopathic treatments aren’t assessed by the FDA.

In a letter to companies that sell Orajel and other benzocaine teething products, the FDA asked them to discontinue any lines marketed for teething relief. As stated in the letter, benzocaine products marketed to adults, including Orajel, are still considered safe, but the manufacturer must include two additional warnings: one informing consumers about the risks of methemoglobinemia and another telling consumers that Orajel should not be used for children younger than 2, or for teething.

Even before the FDA issued these warnings, the American Academy of Pediatrics didn’t approve of these types of teething painkillers because the tiny baby bodies can effortlessly swallow too much of a teething gel.  The FDA directed all manufacturers of over-the-counter oral benzocaine products to include warnings to their label regarding methemoglobinemia. FDA insisted on label changes that further directed the products not fit for teething or for any other reason in children below 2 years old. Manufacturers were also directed to stop promoting benzocaine products for use in infants.

Orajel Teething Products Recalled

Companies involved in the manufacture of benzocaine products acted swiftly to adhere to the FDA’s requirements. Church & Dwight, Inc., the sales and marketing company for Orajel, issued a press release stating the immediate discontinuation of the following products:

  • Orajel Medicated Daytime & Nighttime Teething Twin Park
  • Orajel Medicated Nighttime Teething Gel
  • Orajel Medicated Teething Swabs
  • Orajel Medicated Teething Gel

For the voluntarily recall of Orajel teething products, the company said that the safety of consumers was their highest priority. In addition to the recall, the company plans to update its Drug Facts Labels on other healthcare products. Healthcare professionals and consumers are encouraged to report any adverse effects of Orajel through the FDA MedWatch program.

Understanding Methemoglobinemia: A Rare but Deadly Blood Disorder

The blood uses a process that employs hemoglobin, a protein in red blood cells, to carry oxygen to the cells in the body. As the blood carries oxygen through the bloodstream, hemoglobin releases that oxygen to the cells. However, one type of hemoglobin, known as methemoglobin, does not release oxygen. So, when the blood has too much methemoglobin, the cells in the body don’t receive enough oxygen.

In 2007, researchers documented how a patient with cystic fibrosis developed the low-oxygen blood condition following a double-lung transplant. The patient suffered complications, and doctors needed to thread an instrument down the through to examine his lungs. The doctors sprayed benzocaine in the patient to ease discomfort caused by the bronchoscope.

After about 20 minutes, the patient’s skin became bluish, and he started having breathing difficulties. These are 2 of the major symptoms of methemoglobinemia. Another thing they observed is that the patient’s blood sample appeared to be chocolate-brown in color. His methemoglobinemia level was more than 20%. A chemical known as methylene blue was administered to cure blood disorder. The patient’s skin color turned back to normal about 20 minutes later, and tests affirmed that the level of methemoglobin in his blood returned to normal.

A Study by the FDA Links Methemoglobinemia to Benzocaine

Benzocaine is one of the most common causes of acquired methemoglobinemia, which is the kind of disorder that is not present at birth, as compared to congenital methemoglobinemia, a type that is present at birth. A study by the FDA compares the ability of benzocaine and lidocaine (another local anesthetic) to make methemoglobin. The findings revealed that benzocaine produced much more methemoglobin compared to lidocaine. In 2018, the FDA said that it had successfully evaluated 119 cases of methemoglobinemia associated with benzocaine. The cases were reported to the agency and recognized in the medical literature in 2017. Of those cases:

  • 11 occurred in children younger than 2,
  • 22 were patients under 18, and
  • 4 involved patients who died, including an infant.

Study Calls Orajel and other Benzocaine Products Health Hazards for Children

Researchers in a different study scrutinized records of the California Poison Control System for all calls made between January 2004 and December 2014. During that period, the center obtained 157 reports of benzocaine exposure in children. According to the 2017 study in the Western Journal of Emergency Medicine, the majority of the cases were triggered by unintentional exposures linked to exploratory behavior in toddlers. In most incidents, the child was not injured, but four children sustained major effects. They were treated with methylene blue and other supplemental oxygen treatments.

The researchers concluded that this large case series of benzocaine exposure suggests the wide availability of topical benzocaine products, made for pediatric-age population, continues to cause harm and pose a child health hazard.

Symptoms of Low Blood Oxygen

After using benzocaine, symptoms of methemoglobinemia may manifest within minutes and can also take up to 2 hours in some cases. The FDA states that symptoms may appear after the first- time use of Orajel or after a number of uses. It can also occur with or without benzocaine overdose. The most common symptoms of methemoglobinemia symptoms are cyanosis and chocolate brown-colored blood. Cyanosis refers to a bluish color of the skin, especially showing in the fingers and lips. Cyanosis is the reason why this blood disorder is sometimes called ‘blue baby syndrome.”

According to a 2006 study in Pediatrics, this disorder was discovered in a three-year-old boy who underwent an endoscopic procedure without any complications. The boy developed methemoglobinemia resulting from benzocaine spray used before the procedure. The study revealed that his altered mental status and cyanosis rapidly resolved following an intravenous administration of methylene blue. Other symptoms that may manifest when there’s a rise in blood levels of methemoglobin include:

  • Nausea
  • Rapid heart rate
  • Shortness of breath
  • Headache
  • Coma
  • Lightheadedness
  • Fatigue
  • Excessive saliva
  • Confusion or stupor
  • Loss of consciousness
  • Death

Risk Factors for Adults Using Benzocaine

While children are more at risk for methemoglobinemia with benzocaine use, adults can also be affected. Certain conditions put adults at greater risk for methemoglobinemia, including smoking, having heart disease, and having breathing problems such as asthma, emphysema, or bronchitis. This increased risk should be included in the warning labels of oral benzocaine products such as Orajel. Hospitalization may be required as part of the treatment of methemoglobinemia. If this blood disorder left untreated or treatment is delayed, it may cause permanent injuries to the brain and body tissues. A severe case can lead to death.

Common Side Effects of Orajel

Other than methemoglobinemia, Orajel teething products carry a number of other side effects, including:

  • Irritability
  • Bluish color of the fingernails, skin, lips, nail beds, and palms
  • Sore throat
  • Red, sore eyes
  • Burning or stinging of the skin
  • Fever
  • Swelling of the skin
  • Blistering, flaking skin

If you or a loved one develops any of the aforementioned side effects, make sure that you discuss them with your doctor.

Some individuals may experience an allergic reaction to benzocaine. If this occurs, emergency medical help should be sought immediately. Typical symptoms of an allergic reaction to benzocaine include:

  • Breathing difficulty
  • Hives
  • Swelling of the face, tongue, lips, throat

Alternative Options for Teething Pain

According to the FDA, the risks of using Orajel to relieve teething pain in children younger than 2 years greatly outweigh its potential benefits. The FDA recommends that parents and caregivers stick to the American Academy of Pediatrics (AAP) guidelines instead.  As an alternative to over-the-counter teething discomfort medications, the AAP advises a parent or caregiver to gently massage or rub the child’s gun with a finger, or give the child a teething ring made of hard rubber.  The AAP advises against frozen teething rings because they become too hard and pose more harm than good to the child. It also recommends against the use of teething tablets containing the plant belladonna because it’s poisonous.

Alternative Treatment for Adults

Alternative treatments for adults experiencing mouth pain include OTC pain relief medications and dilute salt water mouth rinse. The agency urges adult to adhere to the recommendations for mouth sores and spots by the American Dental Association, including:

  • Avoid all tobacco products
  • Schedule regular oral health checkups
  • Consult your dentist if you notice any change in your mouth
  • Keep a diary of what you eat and drink
  • If you drink alcoholic beverages, ensure you moderate
  • Keep a list of oral hygiene products you’ve been using

Public Citizen Lawsuit and FDA warnings

In 2017, the advocacy group Public Citizen filed a lawsuit against the FDA, seeking to compel the agency to take action on a petition the group had filed back in 2014 concerning the uses and warnings of benzocaine. The petition requested the agency to eliminate infant teething pain as one of the approved benzocaine uses. The advocacy group asked the FDA to advise against the use of products that contain this chemical for infant teething pain. Public Citizen further requested warnings concerning the risk of methemoglobinemia on oral products containing benzocaine.

This lawsuit states that the FDA has been aware of the link between benzocaine and methemoglobinemia as far back as 1991. However, for more than 25 years, the public was not warned about the risk. According to the lawsuit, the FDA classified benzocaine as an OTC anesthetic and analgesic. It also highlighted that such products were not useful or necessary to treat teething pain because they tend to wash off the gums within minutes. According to Public Citizen, the advisory review panel that took part in the classification of teething products such as Orajel identified the link to methemoglobinemia. The panel was also aware that infants were more vulnerable to the condition. The FDA issued safety announcements concerning the risk of methemoglobinemia on several occasions between 2003 and 2014.

In 2014, the agency was reported to have told manufacturers of OTC, oral health products that it wouldn’t object if a warning regarding the blood disorder was added to their product labels. Until May 23, 2018, a day before responding to the Public Citizen’s petition and a lawsuit, the agency did not obligate drug manufacturers to include the warning on the labels.

Orajel Lawsuits

After the FDA announcement and Church & Dwight, Inc. voluntary recall of the Orajel teething products, lawyers countrywide started preparing benzocaine lawsuits again manufacturers on behalf of adults, children, and infants who have suffered from severe blood disorder methemoglobinemia and other health conditions after using Orajel.  

By definition, a corporation is profit-seeking and is not under obligation to act morally. This is one of the reasons why we frequently see dangerous devices, drugs, and products marketed and sold to consumers. The large corporations that manufacture and sell dangerous products give priority to profit over people. There would be no lawsuits if the same corporations were to properly and adequately warn consumers of these risks. Lawyers are pursuing Orajel lawsuits on behalf of those who were not warned of the risk of injury from the use of benzocaine.

Orajel Mass Tort Lawsuit

It’s common for injured people to refer to their case as a “class action” because it was combined with other cases filed by people injured by the same product. This is not always the case. In most cases involving dangerous drugs, lawsuits are referred to as a mass tort because they are grouped together to allow attorneys and judges to address common issues.

A mass tort is a civil action that involves many plaintiffs against one or a few defendants. These lawsuits are typically handled in multidistrict litigations (MDL), which is a procedural tool used when individuals have suffered injuries from products manufactured by the same defendant(s). The number of damages that may obtain as compensation in a mass tort often vary from one plaintiff to the other, depending on the circumstances of the case and the extent of damages.

Pursuing a Lawsuit for Damages

Orajel teething products have a harmful side effect, and using them may result in serious health conditions. With Orajel, the manufacturing company failed to inform its’ consumers about these dangers appropriately. As a plaintiff, you may get compensated for any injuries caused by dangerous drugs under legal theories of breach of warranty, strict liability, negligence, or misrepresentation. Each of these theories requires proof of various aspects, but generally, you have to show:

  • That the drug was dangerously defective,
  • that you sustained injuries,
  • the injuries were caused by the defect, and
  • you incurred damages.

Proving a drug defect can be done in two ways. A plaintiff may demonstrate that the drug failed to work as safely as an ordinary consumer would anticipate when used as intended. Alternatively, a plaintiff can show that the product’s design was the main cause of the injury, and the risk of dangers outweighs the benefits. Marketing defects refer to errors in the instructions or warnings that come with the drug. Cases involving marketing defects usually turn on a failure to provide proper warnings about the dangerous side effects of a drug. In a negligence action, the plaintiff has to prove that the defendant failed to use reasonable care in the design, manufacture, and marketing of the drug. This includes failing to disclose information to the FDA, failing to provide appropriate warnings, and concealing information about adverse events linked to the drug.

The FDA has continued its investigation into whether Orajel and other benzocaine products pose fatal risks. Those injured as a result of administering these teething products can file personal injury claims to seek compensation. Since medicines and medical issues are highly complex, it’s almost always important to work with an attorney and other health professionals who can help evaluate your claim and collect important evidence to back the claim your injury was caused by the drug.

While Church & Dwight, Inc. pulled several teething products from the market, it is still liable for injuries sustained by plaintiffs because they failed to warn consumers about the dangers of the product adequately. Plaintiffs in Orajel lawsuits claim that the manufacturer marketed the teething products as effective remedies to help alleviate the pain and discomfort of teething in babies and children. The plaintiffs also claim that defendants provided misleading information about the safety of their products.

Find Help for an Orajel Mass Tort Near Me

The interest in Orajel Mass Torts follows the release of a warning by the FDA regarding the dangers of benzocaine products. Mass Torts involving dangerous drugs such as Orajel are often highly complex, especially when it comes to establishing liability. Such cases require the assistance of medical experts, investigators, and expert witnesses.

If you or your child has been injured by Orajel, the legal experts at Consumer Alert Now can help you seek justice for all your injuries and losses. We stand ready to listen to your story and help determine the best course of action against the pharmaceutical company.  We can link you with experienced mass tort attorneys who can help you get the justice you deserve. Use our online contact form below or call us at 800-511-0747 to arrange a free consultation. We operate nationwide.