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South Carolina Dangerous Drug Lawyers Representing Victims of Benzocaine (Tooth Numbing Medication) Related Illnesses

Fighting for the health of children exposed to harmful products

The U.S. Food and Drug Administration (FDA) recently issued a warning to consumers to stop using over-the-counter oral drug products that contain benzocaine on children younger than two years old. Typically these products are used for infants who are teething. The FDA also sent letters to manufacturers asking that they stop selling the product.

Although many parents use Over-the-Counter (“OTC”) teething gels to temporarily relieve their child’s teething pain, the FDA is warning these topical medications may pose a serious health risk to infants and children. The warning also notes that these products often aren’t effective, as they are topical and usually wash out of the mouth quickly.

Benzocaine products are sold as gels, ointments, sprays, lozenges, and solutions under the brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel, and Topex. The FDA warning also includes store brands and generics. Brands marketed to adults can stay on the market, but may need to change their label information.

Benzocaine and oxygen levels in the blood

The risk this dangerous drug poses concerns a condition known as methemoglobinemia, a potentially fatal process where the oxygen level in the blood dips extremely low. Symptoms include rapid heart rate, lightheadedness, difficulties breathing, headache, sleepiness, pale skin, and nail beds that are blue or gray. Usually, symptoms manifest minutes after the product is used or up to one to two hours later. If an infant exhibits these symptoms, the child should get medical attention immediately.

In its warning, the FDA notified companies that if they don’t stop selling benzocaine products, they will take regulatory action to remove the products from stores. In a statement provided to CNN, FDA Commissioner Dr. Scott Gottlieb said, “Because of the lack of efficacy for teething and the serious safety concerns we’ve seen with over-the-counter benzocaine oral health products, the FDA is taking steps to stop use of these products in young children and raise awareness of the risks associated with other uses of benzocaine oral health products. The FDA is committed to protecting the American public from products that pose serious safety risks, especially those with no demonstrated benefit.”

The FDA will also require that any prescription local anesthetics for teething children update their product warnings to inform parents that those medications also carry the risk of methemoglobinemia.

The American Academy of Pediatrics recommends using hard rubber teething rings and avoid frozen teething toys, as they can injure a child’s mouth and cause further pain. They also recommend rubbing your child’s gums to provide immediate relief.

Previous teething product warnings

This is not the first time the FDA has issued a warning about benzocaine. In 2011, they warned consumers about the connection between the products and methemoglobinemia. They estimated at that time there were more than 400 benzocaine-related methemoglobinemia cases reported to the FDA, or noted in medical literature since 1971. These are only documented cases, and there are likely more that went unreported.

Manufacturers should be aware of and act upon FDA warnings about their products. The FDA only issues warnings after injuries have already occurred and innocent people or children have already suffered harm. These products are supposed to make your child feel better—not give them a potentially fatal condition. We can help you if you or anyone in your family has suffered harm due to use of benzocaine products.

South Carolina dangerous drug attorneys provide skilled representation

At McGowan, Hood & Felder, LLC, we fight negligent drug manufacturers on behalf of children who can’t fight for themselves. It’s important to hold these companies responsible for their actions, and it’s important you and your family obtain compensation for your injuries. Let us help. Talk to our South Carolina dangerous drug attorneys today by calling 803-327-7800 or filling out our contact form and scheduling an appointment. We are based in South Carolina, but have helped people throughout the country seek justice. We maintain offices in South Carolina in the cities of Columbia, Anderson, Rock Hill, Sumter, Charleston, and Georgetown.