Updated: Jul 21
Pregnant women can use oragel while pregnant only if the benefits outweigh the risks. The reason is because oragel, which is made of benzocaine is a pregnancy category C drug.
Table of Contents:
What are pregnancy risk categories?
The pregnancy risk categories is a FDA guideline for the relative safety of medications to be used during pregnancy and lactation. They have been in use and guiding doctors since 1979. There are a total of five different categories (taken from this study):
Category A: No risk in human studies (studies in pregnant women have not demonstrated a risk to the fetus during the first trimester).
Category B: No risk in animal studies (there are no adequate studies in humans, but animal studies did not demonstrate a risk to the fetus).
Category C: Risk cannot be ruled out. There are no satisfactory studies in pregnant women, but animal studies demonstrated a risk to the fetus; potential benefits of the drug may outweigh the risks.
Category D: Evidence of risk (studies in pregnant women have demonstrated a risk to the fetus; potential benefits of the drug may outweigh the risks).
Category X: Contraindicated (studies in pregnant women have demonstrated a risk to the fetus, and/or human or animal studies have shown fetal abnormalities; risks of the drug outweigh the potential benefits).
What does the pregnancy risk category for oragel mean?
Oragel, whose main ingredient is benzocaine, is classified as a category C medication and that means the risk cannot be ruled out. This category is a little bit ambiguous since animal studies have demonstrated risk to the fetus but there have been no satisfactory human studies on pregnant women
Ultimately, what that means is that the risks are possible but we are currently unsure if there is a 100% correlation.
The main concern over whether or not to use oragel lies in the fact that studies have shown that it may induce methemoglobinemia in infants. This condition results in insufficient oxygen being carried by your red blood cells to the rest of your body. A dire consequence would be cyanosis, where your skin, lips, and fingers start turning blue due to lack of oxygen.
There was one other study which showed that a single spray of benzocaine may induce methemoglobinemia.
Therefore, the recommendation is to avoid using oragel if there are alternatives or if the situation does not call for it. However, it may still be used if it is absolutely necessary and it may bring benefits to the pregnant mother.
When do the benefits outweigh the risks?
Overall, it IS permissible to use oragel while pregnant IF the situation requires it such as an emergency or a life threatening situation. All other situations which are not emergent nor urgent, should try to find an alternative medication if possible. That would be in the best interest of the pregnant woman.
Here are some examples of emergencies where the benefits outweigh the risks:
Major surgery required due to an accident like a car collision
Emergency where there is a lot of active blood loss
When the benefits do not outweigh the risks - using oragel is not advisable
Aside from situations similar to those above, all elective surgical procedures would not qualify because it is not worth the risk. For elective procedures, those can always wait until after giving birth.
Here are some examples of elective procedures where the benefits do not outweigh the risks, basically anything that is cosmetic would fit the criteria.
Small cavity filling
Getting a mouth full of dental veneers
Cosmetic dermatology procedure
You have a toothache and want to use it to numb the tooth.
That last point should be paid close attention to because if you're having a toothache, you shouldn't use oragel. The reason is because the oragel does not address the source of the tooth pain but merely offers palliative effects. This means that once the oragel wears off, the pregnant woman will be in pain again. The best thng to do in this case would be to see a dentist to have the situation fixed immediately.
It is definitely not healthy for a pregnant woman to be constantly using oragel to try to alleviate their toothache. In fact, oragel doesn't even numb your tooth for that long, at most it would be 20 minutes so its much better to just go to the dentist.
While pregnant women can use oragel, it is typically advisable not to use it if it is not absolutely necessary because it may pose a risk to the unborn child. The reason is because it is a category C drug, which means that animals studies have demonstrated risk. However, due to insufficient human studies, oragel may still be used if the benefits outweigh the risks.
Author: Written by Dr David Chen, a long island city dentist.