Medication Consultation Before Pregnancy: Risks of Norina During Early Gestation - Pharmacology

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Preconception Medication Consultation


I started taking Norina 5mg on March 4 and March 11, each for three consecutive days, totaling 11 pills, and I have not had my period.
Today, I confirmed at Mackay Hospital that I am 5 weeks pregnant.
Does this medication pose any risks to the fetus? Can I continue with the pregnancy?

Ms. Chen, 30~39 year old female. Ask Date: 2016/03/24

Dr. Liao Lingmei reply Pharmacology


Hello: Norina must be used only in the absence of pregnancy (as noted in the attached package insert).
According to the U.S.
Food and Drug Administration (FDA), it is classified as Category X for pregnancy risk, which generally means that there is evidence from animal or human studies indicating teratogenic effects, or based on human experience, it poses a risk to the fetus.
Whether to continue a pregnancy should be discussed with a physician, who can provide guidance after considering all relevant factors and determining the best course of action or implementing close monitoring measures.
Wishing you health and happiness!

Reply Date: 2016/03/24

More Info


Norina, which contains the active ingredient norethisterone, is classified as a Category X medication by the U.S. Food and Drug Administration (FDA). This classification indicates that there is clear evidence from animal or human studies that the drug can cause fetal abnormalities or pose a risk to the fetus. Specifically, norethisterone has been associated with teratogenic effects, which means it can lead to malformations in the developing fetus. Given that you have confirmed a pregnancy of approximately five weeks after taking Norina, it is crucial to understand the implications of this medication on your pregnancy.

The use of Norina during early gestation raises significant concerns. The first trimester, particularly the first eight weeks, is a critical period for fetal development, as this is when major organs and systems are forming. Exposure to teratogenic substances during this time can lead to congenital anomalies. The risks associated with norethisterone include potential developmental issues related to the reproductive and urinary systems, as well as other organ systems.
Since you have already confirmed your pregnancy, it is essential to discontinue the use of Norina immediately. The sooner you stop taking the medication, the better the chances that any potential risks to the fetus can be minimized. If you have taken the medication within the first 20 days post-conception, the likelihood of causing significant harm is lower, but it is still not without risk.
Continuing the pregnancy after exposure to Norina is a decision that should be made in consultation with your healthcare provider. They will likely recommend close monitoring of the pregnancy, including ultrasounds and other assessments to evaluate fetal development. It is important to have open discussions with your healthcare provider about any concerns you may have regarding the health of your baby and the potential impacts of the medication.

In addition to immediate concerns regarding Norina, it is also advisable to discuss any other medications you may be taking or plan to take during your pregnancy. Some medications can have adverse effects on fetal development, and your healthcare provider can help you navigate these concerns by suggesting safer alternatives if necessary.

In summary, while Norina poses risks to the developing fetus, the decision to continue the pregnancy should be made with the guidance of a healthcare professional. They can provide the necessary support and monitoring to ensure the best possible outcome for both you and your baby. It is crucial to prioritize your health and the health of your unborn child by seeking professional medical advice and adhering to their recommendations.

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