The pharmaceutical company Church & Dwight markets a line of Orajel products for mouth pain such as cold sores and canker sores. Until recently, Church & Dwight’s product line included oral pain relievers marketed to parents of teething babies. The company announced that it would stop distributing Baby Orajel products in response to a Food and Drug Administration (FDA) threat to ban those products because of the risk that the active ingredient — benzocaine — poses to babies.
The FDA acted after receiving hundreds of reports of patients developing a serious disease following their use of oral benzocaine. The disease is methemoglobinemia, a condition that reduces oxygen in the blood supply. Babies are particularly susceptible to the disease. “Blue baby syndrome” is often caused by methemoglobinemia.
Parents whose babies experienced cyanosis (skin that turns blue or gray) or other symptoms of methemoglobinemia after using an Orajel product should seek legal advice from a law firm that handles claims against drug companies. Many parents have started or joined lawsuits to recover compensation for harm suffered by their babies and infants after they used Baby Orajel for teething pain.
FDA Warns Parents Not to Use Medication for Teething Pain
According to the FDA, no medication helps children cope with teething pain. Teething is a normal part of growth. While parents hate to see their children experience any kind of discomfort, exposing a baby to oral medications for teething places a child at risk without providing a corresponding benefit.
The FDA advises parents that oral medications “are not useful for treating sore gums due to teething because they wash out of a baby’s mouth within minutes.” Yet drug companies have marketed teething products as if they are effective.
Parents who want to help their teething children should follow the advice of pediatricians by giving their child a teething ring made from firm rubber. Teething babies have an urge to chew, but should only use a teething ring when parents are present to avoid any risk of choking. If a baby’s gums are swollen and tender, parents can also provide temporary pain relief by massaging the gums.
Pediatricians warn against homeopathic teething tablets that contain the plant poison belladonna and gels with benzocaine. The FDA echoes that warning, and specifically identifies the following products containing benzocaine that should never be given to a baby:
- Baby Orajel
Grandparents, babysitters, and childcare workers should all be cautioned against using medications for teething pain.
Baby Orajel May Still Be on Store Shelves
Responsible pharmacies and supermarkets are removing Baby Orajel products from their shelves. Some stores are even offering a refund. Yet Church & Dwight’s announcement states only that it will stop distributing the product. While Church & Dwight has not publicized a recall, “confidential” documents suggest that Church & White has authorized stores and distributors to return Baby Orajel products to Church & White.
The documents indicate that Church & Dwight is no longer marketing the following Baby Orajel products:
- Orajel Medicated Daytime Teething Gel
- Orajel Medicated Nighttime Teething Gel
- Orajel Medicated Daytime and Nighttime Teething Gel
- Orajel Medicated Teething Swabs
Since the degree to which the any informal recall has been implemented is unclear, Baby Orajel products may still be on store shelves. Just as importantly, they may be in medicine cabinets of parents around the nation. Parents who purchased a Baby Orajel product should destroy it or return it to the store from which it was purchased.
Church & Dwight also markets several other Orajel products containing benzocaine. Many other companies also make oral benzocaine products for mouth pain. Those products pose a risk to adults, but benzocaine is associated with a heightened risk in children. Parents can avoid the health risks associated with oral benzocaine by not giving any product containing benzocaine to a child of any age.
Recognizing the Symptoms of Methemoglobinemia
Methemoglobinemia occurs when the body’s blood supply contains too much methemoglobin. While most hemoglobin (technically known as oxyhemoglobin) carries oxygen from the lungs to organs and tissues throughout the body, a form of hemoglobin known as methemoglobin is incapable of binding oxygen.
The body produces methemoglobin naturally (particularly after the consumption of food or water containing nitrates or nitrates), but methemoglobin does not usually exceed 1% or 2% of the blood supply. An enzyme that most people produce after the age of 6 months regulates the supply of methemoglobin by changing methemoglobin to hemoglobin.
Benzocaine causes some people to develop more methemoglobin than the body can regulate. When that happens, individuals (and particularly babies) are at risk of experiencing the life-threatening consequences of methemoglobinemia.
Cyanosis is usually the first symptom of methemoglobinemia. Parents should seek immediate treatment for a baby whose skin appears to be blue or slate gray. Cyanosis results from a lack of oxygen in the body’s tissues. Cyanosis and other symptoms can develop within seconds after the use of oral benzocaine products.
Other symptoms that may accompany or follow cyanosis include:
- Rapid heartbeat
- Difficulty in breathing
- Loss of consciousness
In its advanced stages, babies and adults can enter a coma or suffer from heart failure. Prolonged loss of oxygen can cause brain damage and impair other organs. In some cases, methemoglobinemia is fatal.
Baby Orajel Lawsuits
The link between oral benzocaine and methemoglobinemia has been known for years. Reports of benzocaine causing methemoglobinemia in pediatric populations have appeared in medical literature since at least 1987. The FDA began to warn consumers about the link between benzocaine and methemoglobinemia in 2006 and has repeatedly issued cautions and health advisories about oral benzocaine.
Church & Dwight nevertheless continued to market Baby Orajel products, and did so without warning consumers that using oral benzocaine can cause a deadly disease. Only this year, after the FDA threatened to ban products containing benzocaine that are marketed as relieving teething pain, did Church & Dwight withdraw Baby Orajel products from the market and begin including warnings about methemoglobinemia with regard to its other Orajel products.
Parents of children who became ill after Baby Orajel was administered for teething pain are bringing lawsuits against Church & Dwight for its failure to warn them of the risks they were taking. Lawsuits seek compensation for medical expenses, for any disability caused by methemoglobinemia, and for their pain and suffering. Lawsuits may also seek punitive damages to hold Church & Dwight accountable for concealing a known health risk from consumers.
Lawsuits are an important means of assuring corporate accountability while compensating injury victims for harms caused by drug companies that put profits ahead of people. Given the FDA’s warning that pain relievers for teething are generally ineffective, the need to hold Church & Dwight accountable for marketing a dangerous product is particularly strong.
While strict time limits apply to lawsuits, those time limits are often extended when injury victims are children. Obtaining prompt legal advice is nevertheless the best way for parents to protect the opportunity for their children to obtain compensation for a serious illness that could have been avoided by removing Baby Orajel from the market decades ago, when the link between oral benzocaine and methemoglobinemia became clear.
Advocate Law Group represents patients who are suffering, or have suffered, from Methemoglobinemia in claims against the manufacturers and distributors of products containing oral benzocaine. You may be entitled to compensation if you have suffered harm, but you should contact Advocate Law Group promptly to avoid losing your right to seek a legal remedy for your or a loved one’s condition.