Pregnancy Safety: Concerns About Nasal Ointment and Sprays

Q: Pregnancy Safety: Concerns About Nasal Ointment and Sprays

Hello： The "Spersin Ointment" contains Neomycin, which is classified as Category D by the U.S. <br>Food and Drug Administration (FDA) for use during pregnancy. <br>This means that there is confirmed evidence of risk to human fetuses, but it may be used if absolutely necessary for

Pregnancy Medication: Nasal Ointment

I visited an otolaryngologist due to discomfort in my nose and informed the doctor that I am over four months pregnant.
The doctor first sprayed a nasal spray for an endoscopic examination and then applied a layer of "Spersin Ointment" (a broad-spectrum antibiotic ointment) inside my nasal cavity.
Additionally, I was given this ointment to take home.
However, upon reviewing the instructions at home, I noticed that it states it is not suitable for pregnant women, which has made me very concerned.

1.
The ingredients are Neomycin, Bacitracin, and Polynesian B1.
Could these ingredients harm the fetus?
2.
If they could cause harm, would applying it just once (the application done by the doctor) still have an impact?
3.
Furthermore, could the nasal spray that the doctor used (the ingredients of which I am unaware) also have any effects?

CC, 30~39 year old female. Ask Date: 2016/03/01

Dr. Liao Lingmei reply Pharmacology

Hello: The "Spersin Ointment" contains Neomycin, which is classified as Category D by the U.S.
Food and Drug Administration (FDA) for use during pregnancy.
This means that there is confirmed evidence of risk to human fetuses, but it may be used if absolutely necessary for the pregnant woman.
It is important to note that this classification refers to the safety and risks of oral administration of Neomycin.
Bacitracin is classified as Category C by the FDA, indicating that animal reproduction studies have shown an adverse effect on the fetus (teratogenic effects, embryonic death), but there are no controlled studies in pregnant women; or there are no observational studies in animals or humans.
Polymyxin B carries a pregnancy risk where fetal risk cannot be ruled out.
(Available evidence is inconclusive or inadequate for determining fetal risk when used in pregnant women or women of childbearing potential.
The potential benefits of drug treatment should be weighed against potential risks before prescribing this drug during pregnancy.) In general, this means that there is currently insufficient evidence to determine the harm to the fetus when used in pregnant women, and the efficacy (benefits) and risks of the medication should be considered.
Additionally, it is mentioned that the medical use of sprays may serve as a local anesthetic for the nasal mucosa, with minimal amounts being quickly eliminated from the body, thus posing no significant harm.
My personal conclusion is to recommend that you use the ointment as prescribed to avoid infection at the affected site.
While topical medications may have some degree of systemic absorption, in your case, it is not for long-term use, so please feel assured to follow your doctor's instructions.
Wishing you health and happiness!

Reply Date: 2016/03/01

More Info

When it comes to the safety of using nasal ointments and sprays during pregnancy, it is crucial to consider the specific ingredients and the potential risks associated with them. In your case, you mentioned that you were treated with Spersin Ointment, which contains Neomycin, Bacitracin, and Polymyxin B. Let's break down the safety of these components and address your concerns.

1. Neomycin: According to the FDA, Neomycin is classified as a Category D drug during pregnancy. This means that there is evidence of risk to the fetus based on human data, but it may be used in pregnant women if the benefits outweigh the risks. Neomycin is primarily known for its use in topical applications and is generally avoided in systemic use during pregnancy due to its potential ototoxicity and nephrotoxicity.

2. Bacitracin: This is classified as Category C by the FDA, indicating that animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. The use of Bacitracin should be approached with caution, especially during pregnancy.

3. Polymyxin B: This drug is also classified as Category C, meaning that the risk to the fetus cannot be ruled out. The available evidence is inconclusive, and the decision to use this medication should involve weighing the potential benefits against the risks.

Given that you were treated with these medications only once during your doctor's examination, the immediate risk to your fetus is likely minimal, especially if the application was localized and not systemic. However, it is essential to monitor for any unusual symptoms or reactions.

Regarding the nasal spray used during your examination, without knowing the specific ingredients, it is challenging to assess its safety. Many nasal sprays contain decongestants or corticosteroids, which can have varying effects during pregnancy. Generally, localized nasal sprays are considered safer than systemic medications, but it is always best to consult with your healthcare provider about the specific product used.

In summary, while there are concerns regarding the use of Neomycin, Bacitracin, and Polymyxin B during pregnancy, the one-time application you received is unlikely to cause significant harm. However, it is crucial to follow up with your healthcare provider for personalized advice and to discuss any ongoing symptoms you may be experiencing. They can provide guidance on safe alternatives for managing nasal discomfort during pregnancy, ensuring both your health and that of your developing baby. Always prioritize open communication with your healthcare team regarding any medications or treatments during this critical time.

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