FDA Warns Public of Dangers of Over-the-Counter Benzocaine Products

 Posted on May 30, 2018 in Product Liability

The Food and Drug Administration (FDA) published a warning on May 23 that over-the-counter teething products containing benzocaine can cause harmful and potentially deadly side effects when used on children, especially those under two years of age. Benzocaine can be found in products such as Baby Orajel, which is commonly used on infants to soothe the pain of teething. If your child has been injured after using one of these types of products, it is important to understand your options for pursuing compensation through a product liability lawsuit.

Benzocaine Can Be Deadly to Children

The statement that the FDA published said that the use of benzocaine in products used on infants poses a serious risk to their health. Benzocaine can cause methemoglobinemia, a condition that causes dangerously low oxygen levels in the bloodstream. Symptoms of methemoglobinemia usually appear anywhere between 20 and 60 minutes after being given benzocaine and can include:

• Slight gray or blue tint to the skin;
• Weakness;
• Confusion;
• Palpitations;
• Abnormal heartbeat;
• Seizures;
• Coma;
• Sleepiness; and
• Difficulty breathing.

Severe cases of methemoglobinemia can cause death.

FDA Orders Products to be Pulled From Shelves

The FDA stated that benzocaine products should not be marketed for children any longer, and that companies are to pull their products from store shelves and discontinue manufacturing them. Benzocaine products are sold as gels, sprays, ointments, and lozenges under name brands such as Baby Orajel, Cepacol, HurriCaine, and Topex, but they are also sold under store brands and generic brands. Only the products intended for use by children are required to be pulled from shelves--adult medications can stay, but the FDA warns they may need new labeling stating the dangers of the medication.

Product Liability Laws in Illinois

The state of Illinois adheres to what is called a strict product liability theory. This means that it does not matter whether the company that manufactured the product was negligent or not, it just means that the company sold a dangerous product. These types of cases can involve one or more product defects:

• Manufacturing defects;
• Design defects; and
• Marketing defects.

In the case of benzocaine products, the products have marketing defects because they failed to warn the public of the dangers of benzocaine use in children.

Contact an Aurora Personal Injury Lawyer

Parents always want to do what is best for their children. When a company markets a product that does not have adequate warning labels on the packaging, it can pose unnecessary dangers to consumers. If your child has experienced any adverse side effects of benzocaine medication, you need the help and aid of an experienced Kane County product liability attorney. Contact Kinnally Flaherty Krentz Loran Hodge & Masur P.C. to discuss your options for obtaining the compensation you deserve. Call our office at 630-907-0909 to set up a free consultation.

Sources:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608325

https://www.cnn.com/2018/05/23/health/fda-benzocaine-teething-warning/index.html

http://www.illinoiscourts.gov/CircuitCourt/CivilJuryInstructions/400.00.pdf