Benzocaine Teething Gel Side Effects Elicit Warning from Virginia Mom

Published on October 31, 2018 by Laurie Villanueva

A Virginia woman is working to raise awareness about the side effects potentially associated with benzocaine-containing teething remedies, following a harrowing experience with an Orajel product.

“She became limp and stopped breathing,” Danielle Kapetanovic wrote in a  Facebook post earlier this year.. “She turned blue. I grabbed her and put her against my body, hitting her back trying to wake her up, but no response.”

Daughter Unresponsive After Receiving “Pea Sized” Amount of Orajel

Little Chloe was just 15 months old when Kapetanovic purchased Orajel Medicated Nighttime Teething Gel to relieve her daughter’s pain.

The little girl became unresponsive on the evening of February 26th, just second after her mother applied a “pea sized” amount of Orajel to her aching gums.

“I was screaming. It’s the scariest thing that’s ever happened to me,” she told People in March. “I was trying to do everything I could to get her back. It was like she was gone. I picked her up and she was just dangling there. It was absolutely horrifying.”

Kapetanovic administered CPR to Chloe, while her husband called 911.

Fortunately, their daughter regained consciousness and is doing well.

Orajel Marketing Led Mom to Believe it Was Safe for Infants

In an interview with GoodHousekeeping.com, Kapetanovic acknowledged that the packaging for the Orajel product she used on Chloe did advise parents to consult with a doctor before administering it to a child under the age of 2. But she feels misled because of the way in which the drug was marketed.

“I found it in the baby aisle at my local grocery store, right next to other products like baby food and baby wash, so I naturally assumed it was intended for babies,” she said. “This product is intended for children 24 months and older, why does it feature what appears to be a baby on the package?”

What’s more, the websites for several major retailers stated that Orajel Nighttime Teething Gel was recommended for “babies ages 4 months and up” when Kapetanovic made her purchase.

“[The websites] feature disclaimers stating that this product information is provided by the manufacturer,” she says. “In my opinion, Church & Dwight’s advertising of this product directly conflicts with the statement they have provided.”

FDA Urges Manufacturers to Stop Marketing OTC Benzocaine-Based Infant Teething Drugs

Just months after Kapetanovic went public with her experience, the U.S. Food & Drug Administration (FDA) asked manufacturers to discontinue marketing over-the-counter benzocaine teething remedies for infants and children under the age of 2.

The agency acted after a review of adverse event reports and published literature uncovered 400 instances of methemoglobinemia among infants and others treated with benzocaine oral medications. Four of those cases had fatal outcomes, including one that resulted in the death of an infant.

The FDA also requested the following label revisions for over-the-counter benzocaine oral drugs marketed for adults and older children:

  • Addition of a methemoglobinemia warning.
  • Addition a of new contraindications – the strongest warning possible – directing parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years
  • Revised directions informing parents and caregivers not to use the product in infants and children younger than 2 years.

What Should Parents Know About Benzocaine and Methemoglobinemia?

While anyone can develop acquired methemoglobinemia following exposure to certain drugs, foods, or chemicals, babies are especially vulnerable.

For this reason, the  FDA has warned parents and caregivers not to use benzocaine to treat teething pain in infants and children younger than 2. Oral benzocaine treatments should be used be sparingly – not more than 4-times per day – in adults or older children.

Seek medical attention immediately at the first sign or symptom of methemoglobinemia, including:

  • Cyanosis (a bluish color in the skin, especially the lips and fingers)
  • Chocolate-brown colored blood
  • Headache
  • Shortness of breath
  • Nausea
  • Rapid heart rate
  • Fatigue and lethargy
  • Confusion or stupor
  • Loss of consciousness

Infants and children under the age of 2 who experience teething pain should be treated in accordance with recommendations published by the American Academy of Pediatrics..

Get the latest news and litigation updates about this case by following us on Facebook. Click the "Like" button below.

 
 
 

Follow Us

RXInjuryHelp.com on Google+  RXInjuryHelp.com on Facebook  RXInjuryHelp.com on LinkedIn  RXInjuryHelp.com on Twitter  RXInjuryHelp.com on YouTube  RXInjuryHelp.com on Pinterest