FDA Warns of Dangerous Drug in Popular Children’s Medication

The relatively unknown topical pain reliever, benzocaine,  has made headlines for the past week after the U.S. Food and Drug Administration (FDA) issued a warning about a potentially deadly condition caused by the drug on May 23. Benzocaine, a white, odorless powder used as a topical pain reliever, reduces pain by blocking nerve signals in your body. It is used as a topical treatment to alleviate discomfort from canker sores, gum pain and teething. Because the drug quickly washes away in the mouth, it is largely considered ineffective. Additionally, for almost 50 years the drug has been linked to a potentially fatal condition called methemoglobinemia. But, it is still a go-to for many parents with teething babies. You may be more familiar with benzocaine’s brand name: Baby Orajel.

Since 1971, the FDA’s Adverse Event Reporting System has received reports of infants from one month to 2 years suffering from acquired methemoglobinemia linked to products containing benzocaine. That means for 47 years the FDA has known about the link between benzocaine and methemoglobinemia and chose not to act. However, that all changed in May when the FDA ordered benzocaine manufacturers to stop marketing and selling the drug to children under 2 years.

In addition to Baby Orajel, there are several other products that contain benzocaine, including:

• Anbesol
• Cepacol
• Chloraseptic
• Hurricaine
• Orabase
• Orajel
• Topex
• Other store brands

Why did the FDA Issue a Benzocaine Warning?

After nearly 50 years of complaints, the FDA finally took action against over-the-counter teething gels containing benzocaine. Agency officials reviewed 119 cases of methemoglobinemia linked to benzocaine between 2009 and 2017—including four deaths—prior to issuing its 2018 warning. The FDA warned consumers on May 23 of the dangers of teething gels that contain benzocaine. Additionally, the agency sent a letter to companies urging them to no longer market or sell oral health products containing benzocaine to children under 2. The administration will issue regulatory action to remove these products from the market if companies do not comply.

The FDA’s warning comes after growing evidence showed a link between benzocaine products and methemoglobinemia, a potentially fatal condition in which oxygen levels in the blood dips to extremely low levels. Symptoms can start within minutes or up to two hours after administering the product. Contact a benzocaine lawyer right away if your child developed any of the following symptoms within 24 hours of benzocaine exposure:

• Pale, gray or blue colored skin
• Blue/grey nails
• Death
• Excessive sleepiness
• Lethargy
• SIDS

Babies given Baby Orajel or other medicines containing benzocaine who exhibit these symptoms should be treated by a medical professional immediately. The condition is particularly risky to children under two. The generally accepted reason behind the risks to children under two is because of an infant’s small size, their bodies absorb a high percentage of benzocaine. This high absorption rate leads to oxygen deficiency in the bloodstream. 

What are the new requirements under the new FDA Warning?

As part of the new warning, the FDA is requiring manufacturers of all FDA-approved prescription local anesthetics to standardize warning information on labels. The labels should include information about the risks of methemoglobinemia.

In addition to warning about methemoglobinemia, labels should also include:

• Adding contraindications, FDA’s strongest warnings, directing parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years; and
• Revising the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years.

FDA-approved prescription local anesthetic manufacturers will have 30 days to reply to the FDA’s letter regarding the new safety labeling changes

What has the FDA said about Benzocaine in the past?

The FDA’s new stance on over-the-counter benzocaine teething gels, such as Baby Orajel, is an update to an April 2011 warning.  While the FDA did not require manufacturers to do anything, it did warn parents of risks associated with the drug. At the time, it was estimated that more than 400 cases of benzocaine-related methemoglobinemia were reported to the FDA or published in medical literature since 1971. The 2011 safety announcement, primarily had instructions for parents, caregivers and healthcare professionals.

Additionally, the FDA issued warnings about teething products in 2006, 2011 and 2014. However, none of these announcements called for their removal from the market.

The Carlson Law Firm Can Help

Our legal team can provide you with answers you need if you’re wondering if a dangerous drug lawsuit is the right choice for you. We have a wide range of skills that our clients can use to their benefit. We have more than 40 years of experience in representing personal injury victims. A benzocaine lawyer from The Carlson Law Firm will fight for your child. We can help recover the damages your family deserves. Further, our staff will work tirelessly for your child’s benefit. Contact us today for a free consultation. We are available 24/7.