Question:
“Hi there. I am a women’s health NP. I work independently. Recently I saw a 44 yr. old new patient who is on combined oral contraceptives and also on norethindrone day 10 to 21 of her cycle. She stated her previous gyn prescribed the additional progesterone for anxiety in that phase of her cycle. She has been on this regime for about 3 years. I recommended she stop the norethindrone to see how she does without it as I had concerns about taking that much progesterone as well as off label use. She got quite angry and refused. I told her we could consider SSRIs but she doesn’t want to hear it. Do you feel this is safe long term until menopause? She has no co morbidities.”
Answer:
I agree with you, and I would have advised the same. For one, progestins are not usually thought to decrease anxiety, so I find it curious she was prescribed additional progestin for this reason, although at much higher doses progesterone can be associated with some somnolence. If she suffers from premenstrual anxiety, there is evidence that combined pills with Ethinyl estradiol and Drospirenone improve symptoms, and consequently these pills have FDA approval for premenstrual dysphoric disorder. Other pills may also be effective but have not been as well studied. So, depending on what combined pill she is taking, a formulation with these hormones may be tried instead.
I am curious which birth control pill she is on. If she is adding norethindrone, presumably it is in the form of the progestin-only pill, at a dose of 0.35mg. The combination pills that have norethindrone have doses that range from 0.4mg to 1.5 mg of norethindrone per pill, so there is a wide range of doses of the hormone considered safe. Her total dosage may well be in this range, in which case there should be no additional safety concerns if she wants to continue this regimen. It is off label, but off-label usage is acceptable for practice. According to the FDA website “once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.” I hope this is reassuring but feel free to write more with additional questions, or information about her formulation of birth control pills, or the dosage of norethindrone.
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