FDA Issues Safety Alert on Benzocaine: What Consumers Need to Know

If you’ve ever used an over-the-counter oral pain reliever like Anbesol, Orajel, or Baby Orajel, there’s a good chance you’ve come across benzocaine—a common topical anesthetic used to numb mouth and gum pain. But now, the U.S. Food and Drug Administration (FDA) is warning consumers and manufacturers alike: benzocaine can be dangerous, especially for children.

At Nelson, Bryan, and Cross, we stay up to date on FDA drug safety communications to ensure our Alabama clients know their rights and stay informed. Here’s what the recent alert means and what you should do if you or a loved one may have been harmed.

What Is Benzocaine and Why Is It Used?

Benzocaine is found in many oral pain relievers and teething gels. It works by numbing the area where it’s applied, providing short-term relief from:

• Toothaches

• Sore gums

• Canker sores

• Teething pain in infants and toddlers

Common brand names include:

• Orajel

• Anbesol

• Orabase

• Hurricaine

• Generic benzocaine gels or sprays

The FDA’s Safety Concerns

In its Drug Safety Communication, the FDA warned that benzocaine can cause a rare but serious condition called methemoglobinemia. This blood disorder limits the amount of oxygen carried through the bloodstream and can be life-threatening, especially in children under two years old.

Symptoms of methemoglobinemia may include:

• Pale or gray/blue-colored skin, lips, or fingernails

• Shortness of breath

• Fatigue or confusion

• Rapid heart rate

• Headache or dizziness

These symptoms can appear minutes to hours after using benzocaine and may require immediate emergency care.

What the FDA Is Recommending

The FDA is calling for:

• No use of benzocaine products in children under 2

• Label updates and stronger warnings for adult products

• Increased awareness among healthcare providers and consumers

They’ve also urged companies to stop marketing products for infant teething pain that contain benzocaine.

What If You’ve Already Used Benzocaine?

If you or your child has used a benzocaine-containing product and experienced any of the symptoms listed above, seek medical attention immediately. Methemoglobinemia can be diagnosed with a blood test and requires prompt treatment.

You should also:

• Stop using the product

• Report the adverse effect to the FDA’s MedWatch program

• Document all medical care and prescriptions

• Save the product packaging if possible

Do You Have Legal Options in Alabama?

Yes. If you or a loved one suffered serious side effects from benzocaine—especially if it involved hospitalization or long-term injury—you may have grounds for a:

• Product liability claim

• Failure to warn lawsuit

• Dangerous drug injury case

Under Alabama product liability laws, drug manufacturers have a duty to:

• Warn of known risks

• Remove dangerous products from the market

• Avoid targeting children with unsafe formulations

Let Nelson, Bryan, and Cross Protect Your Family’s Rights

When major drug companies put profits over safety, the consequences can be devastating. At Nelson, Bryan, and Cross, we represent families throughout Alabama in cases involving:

• Dangerous over-the-counter products

• Inadequate warnings and labeling

• FDA-recalled drugs and devices

If you believe benzocaine caused harm to you or a loved one, don’t wait. Contact us today for a free, confidential consultation. We’ll review your case and help you understand your legal options.