Norethindrone (Estrostep)

Oral Contraceptive

Pregnancy

Oral contraceptives should not be used during pregnancy. Oral contraceptives are used to prevent pregnancy and should be stopped immediately if a pregnancy is detected. Use of oral contraceptives during the first trimester of pregnancy is associated with negative effects for the mother and the fetus.  

Category: X

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Breastfeeding

Excretion into human milk: Possible

There are no studies done on the risks of oral contraceptives for the baby if used when breastfeeding. 

Oral contraceptives should not be used in the first 3 weeks after giving birth because of an increased risk of blood clots. This is extended to 4 to 6 weeks for women with other risk factors for blood clots. 

Oral contraceptives may decrease the production of breast milk. Opinions vary on the period that women should not use oral contraceptives while breastfeeding from the first 4 weeks for the first 6 months after giving birth.

References
  1. Medlineplus.gov. (2018). Estrogen and Progestin (Oral contraceptives): MedlinePlus Drug Information. [online] Available at: https://medlineplus.gov/druginfo/meds/a601050.html.  [Accessed 4 June. 2018]
  2. PubmedHealth. (2018). Ethinyl Estradiol and Norethindrone (Oral route). [online] Avaliable at: https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0060082/. [Accessed 4 June. 2018]
  3. Toxnet.nlm.nih.gov. (2018). Oral contraceptives (combined). [online] Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~1inLKx:4. [Accessed 4 June. 2018].
  4. Uptodate.com. (2018). Ethinyl estradiol and Norethindrone. [online] Available at: https://www.uptodate.com/contents/ethinyl-estradiol-and-norethindrone-drug-information?search=norethindrone%20ethinyl%20estradiol&source=search_result&selectedTitle=1~19&usage_type=default&display_rank=1. [Accessed 4 June. 2018].
  5. Epocrates.com. (2018). Norethindrone/ ethinyl estradiol. [online] Available at: https://online.epocrates.com/drugs/2453/norethindrone-acetate-ethinyl-estradiol. [Accessed 4 June. 2018].