VIEW MENU

Serious warnings issued about OTC infant teething gels


On Wednesday, June 23, 2018, the U.S. Food and Drug Administration (FDA) issued a warning that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years old. This is significant because many of the medications are marketed specifically for teething infants and toddlers.

Among the teething-relief products containing benzocaine are Orajel Medicated Teething Gel; Nighttime Orajel Medicated Teething Gel; Orajel Medicated Teething Swabs. Additionally, several adult-targeted tooth pain products, including Orajel, Ambesol and DenTek, contain benzocaine.

The FDA stated that the local anesthetic benzocaine can cause methemoglobinemia, a condition in which the amount of oxygen carried through the blood is greatly reduced. This condition can result in death.

Due to the significant safety risk of methemoglobinemia, the FDA has urged manufacturers that they should stop marketing OTC oral drug products containing benzocaine for treating teething in infants and children younger than 2 years old. In a statement on its website, the FDA added, “If companies do not comply, we will take action to remove these products from the market.”

The organization has also called on manufacturers of benzocaine oral drug products to add the warnings to the medication’s label:

  • A warning about methemoglobinemia;
  • 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.

In addition to the FDA’s actions regarding OTC benzocaine products, it has also required a standardized methemoglobinemia warning to be included in all prescription local anesthetics.

 

Share This Story On:

 

Enews Subscribe

Sign up for Central Penn Parent's Daily E-newsletter for the latest blog posts, contests and more.

Subscribe

PA School Finder

How does your child's school rank?

Find Out →

Event Calendar

Events Calendar

« January 2019 » loading...
S M T W T F S
30
31
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
1
2
Mon 21

The Star Barn Village Christmas Light Drive-Thru

December 7, 2018 @ 5:00 pm - January 26, 2019 @ 8:00 pm
Mon 21
Tue 22

Winter Story Time with Mrs. B.

January 22 @ 10:00 am - 12:00 pm
Tue 22

Munchkin Science – Snow

January 22 @ 1:00 pm - 2:00 pm
close
Don't miss our latest Winter stories
Snow day fun – crafts, recipes and experiments See All Stories →