Does Taking Primolut-Nop in Early Pregnancy Affect Fetal Health? - Pharmacology

Share to:

Taking Primolut-N (norethisterone) during early pregnancy may affect fetal health. It is important to consult with a healthcare provider for personalized advice and to discuss potential risks and benefits?


Hello, my partner unknowingly took Primolut-Nop to delay her menstrual period.
Today, we went to the gynecology clinic and found out she is approximately four weeks pregnant.
She took the medication during the second to third week of pregnancy for a total of eight days.
The doctor mentioned that we will need to monitor the embryo's development to decide whether to proceed with a medical abortion, but also reassured us that we shouldn't worry too much, as the embryo may not necessarily have issues.
I would like to ask if Primolut-Nop could have any adverse effects on the early development of the embryo, and what the extent of those effects might be.
Thank you for your response!

JouAnn, 30~39 year old female. Ask Date: 2006/07/19

Dr. Lin Meili reply Pharmacology


JouAnn: The medication your wife is taking is known as Primolut-Nor, which contains the active ingredient Norethisterone acetate.
In the United States, the Food and Drug Administration (FDA) classifies medications for use during pregnancy into five categories: A, B, C, D, and X (please refer to the definitions below).
This particular ingredient falls under category X.
Current research indicates that Norethisterone can lead to malformations of the external genitalia and urinary organs in the fetus.

FDA Pregnancy Category Definitions:
- A: Adequate and well-controlled studies in pregnant women have not shown a risk to the fetus in any trimester.
- B: Animal reproduction studies have not demonstrated a fetal risk but there are no adequate and well-controlled studies in pregnant women; or animal studies have shown an adverse effect but adequate studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
- C: Animal studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans; or there are no animal studies and no adequate studies in pregnant women.
- D: There is evidence of human fetal risk, but the benefits of the drug may outweigh the risks in certain situations.
- X: Studies in animals or humans have demonstrated fetal abnormalities, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Pharmacist Lin Mei-Li

Reply Date: 2006/07/19

More Info


Taking Primolut-Nop (which contains Norethisterone acetate) during early pregnancy raises valid concerns regarding its potential effects on fetal health. As you've mentioned, your partner unknowingly took this medication during the early weeks of pregnancy, specifically from the second to the third week, which is a critical period for fetal development.

Primolut-Nop is classified as a Category X medication by the FDA. This classification indicates that studies in animals or humans have demonstrated fetal abnormalities, and the risks involved in using the drug in pregnant women clearly outweigh any potential benefits. The primary concerns associated with Norethisterone acetate include the possibility of causing malformations in the external genitalia and urinary tract of the developing fetus.
Research has shown that exposure to Norethisterone during the first trimester can lead to various developmental issues, particularly affecting the reproductive system. However, it is essential to note that the actual risk of significant harm can vary based on several factors, including the dosage taken, the duration of exposure, and individual patient factors.

In your case, since the medication was taken for about eight days during a very early stage of pregnancy, the potential for serious effects may be less than if the exposure had been prolonged or at higher doses. The fact that your healthcare provider has advised monitoring the embryo's development is a prudent approach. They will likely perform ultrasounds and other assessments to evaluate the embryo's growth and development, which can provide more information on whether any interventions are necessary.

It's also important to remember that not all exposures to Category X medications result in adverse outcomes. Many pregnancies proceed without complications despite early exposure to potentially harmful substances. The body has mechanisms to mitigate some risks, and many factors contribute to fetal health, including maternal health, genetics, and environmental influences.

In summary, while there is a potential risk associated with taking Primolut-Nop during early pregnancy, the actual impact on fetal health can vary. Continuous monitoring and follow-up with your healthcare provider are crucial to ensure the best possible outcome. If there are any concerns or signs of complications, your healthcare provider will guide you on the appropriate steps to take. It is always best to discuss any worries or questions with your doctor, who can provide personalized advice based on the latest medical guidelines and your specific situation.

Similar Q&A

Does Taking Priligy During Pregnancy Affect Child's Health?

Taking Priligy (dapoxetine) during pregnancy may have potential effects on the health of the child. It is essential to consult with a healthcare professional for personalized advice, as they can provide guidance based on the latest research and individual circumstances. Generally...


Dr. Xu Wencang reply Urology
I cannot.

[Read More] Does Taking Priligy During Pregnancy Affect Child's Health?


Effects of PRIMPERAN on Fetal Development During Early Pregnancy

Hello Doctor: I am currently seven weeks pregnant and experiencing symptoms of morning sickness, including headaches, dizziness, drowsiness, and nausea. Yesterday, I visited an obstetrician, and the doctor prescribed me PRIMPERAN (metoclopramide) to prevent vomiting. However, I c...


Dr. Wu Huiling reply Pharmacology
An anxious pregnant woman: Hello! According to Micromedex 2004, Primperan is classified as a Category B medication by the FDA for use during pregnancy in the United States. This means that human studies have shown no risk, and it has been proven effective in treating vomiting in ...

[Read More] Effects of PRIMPERAN on Fetal Development During Early Pregnancy


Impact of Early Pregnancy Medications on Fetal Health: What to Know

Due to a relapse of depression, I have been taking medication continuously for nearly two years. At the end of August, I learned that I was unexpectedly pregnant. Although I stopped taking the medication immediately upon finding out, I am extremely worried about the potential sig...


Dr. Hou Fangmin reply Pharmacology
Hello: Every prospective mother should be very cautious about the medications she takes, which is very important. Medications during pregnancy are classified into five categories as follows: A - No evidence of risk in the first trimester. B - Animal studies show no harm, but ...

[Read More] Impact of Early Pregnancy Medications on Fetal Health: What to Know


Early Pregnancy: Dietary Concerns and Medication Safety

Hello Dr. Chuang: The first day of my last menstrual period was April 8, and I am currently about four weeks pregnant. During this time, I took an allergy medication that contained: Decadolone 0.5 mg, Tellwell, AlOH 334 mg, Prinate 3 mg, and Buclizine 25 mg. Will this affect my f...


Dr. Zhuang Zhijian reply Obstetrics and Gynecology
1. Taking it only once should not cause significant issues; it is recommended to minimize usage during this period. 2. It should be fine. 3. Currently, there are no research reports indicating that it is necessary to "stay away from the computer."

[Read More] Early Pregnancy: Dietary Concerns and Medication Safety


Related FAQ

Medications During Pregnancy

(Pharmacology)

Drug Side Effects

(Obstetrics and Gynecology)

Medication For Pregnant Women

(Obstetrics and Gynecology)

Early Pregnancy

(Obstetrics and Gynecology)

Prolactin

(Obstetrics and Gynecology)

Drug Interactions

(Obstetrics and Gynecology)

Contraceptive Pills

(Pharmacology)

Menstrual Regulation Medication

(Obstetrics and Gynecology)

During Pregnancy

(Family Medicine)

Medication To Delay Menstruation

(Obstetrics and Gynecology)