Prometrium Side Effects

Question

I have read over the internet that the use of Prometrium cooperatively timed with the menstrual cycle (peak +3 through peak +12) while using NFP may relieve bleeding and menstrual pain. Your site seems to state this also.
However, the manufacturer of Prometrium (Solvay) has the following statement listed on their internet site under side effects:

http://www.solvaypharmaceuticals-us.com/Products/Womens_Health/PROMETRIUM/Safety/Contraindications and Side Effects

* Patients who may be allergic to or have known sesitivities to peanuts should not take Prometriumr Capsules.

* Transient dizziness may occur in some patients; they should use caution when driving a motor vehicle or operating machinery. A small percentage of women may experience extreme dizziness and/or drowsiness during initial therapy. For these women, bedtime dosing is advised.

* Common side effects of PROMETRIUMR Capsules when given alone for secondary amenorrhea are dizziness, abdominal cramping, headache and breast pain. The most frequently occurring adverse events in women taking estrogen(0.625mg/d) and cyclic Prometrium Capsules( 200mg/d for 12d/mo) are: breast tenderness, dizziness, abdominal bloating, vaginal discharge, chest pain and diarrhea.

* PROMETRIUMR Capsules is not recommended for patients with known or suspected pregnancy, current or past history of thrombotic disorders, severe liver dysfunction or disease, known or suspected malignancy of breast or reproductive organs, undiagnosed vaginal bleeding, missed abortion, or as a diagnostic test for pregnancy.

* PROMETRIUMR Capsules is rated Pregnancy Category B.

I have highlighted the pertinent text above that concerns me (… not recommended for patients with known or suspected pregnancy, …missed abortion, …Pregnancy Category B). These warnings seem to indicate a concern with taking such medication if the patient was pregnant. What is the concern here… abortive, birth defects, or other? If abortive, this medication would seem to be in violation to the desired moral principle. Please explain what the side effects listed above mean exactly, and answer whether an abortive effect is increased at all by use of this medication.

Thanks, Joe

Answer

Last Updated: June 14, 2013
Prometrium in the latter part of the menstrual cycle can help with heavy bleeding due to progesterone deficiency. It does not specifically help menstrual pain, except that sometimes pain is due to the passage of large clots, and reduction of bleeding can reduce pain. Prometrium is identical to progesterone, which is produced in large quantities in normal pregnancies. It has never been shown to be harmful to any fetus. Progesterone in its various forms is used liberally by fertility physicians to prevent miscarriage and has many other uses during pregnancy. There is no abortive effect. Prometrium is category B because some artificial progesterone derivatives have undesirable effects (not shared by progesterone), and the manufacturer has not gone through the massive testing to exempt Prometrium from this general category. The “dizziness” is really similar to the fatigue or relaxation some women feel in early pregnancy. This is minimized by taking the medication at bedtime. Similarly, the other symptoms are like early pregnancy symptoms. These symptoms can be lessened by using a vaginal preparation of progesterone rather than an oral one.

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