Modafinil/Armodafinil - Birth Control and Pregnancy
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Modafinil (sometimes referred to by it's brand names Modavigil or Provigil ) and its derivative Armodafinil (also known as Nuvigil) are medications that promote wakefulness. They are prescribed to assist with excessive sleepiness associated with sleep disorders such as Narcolepsy, Idiopathic Hypersomnia and Sleep Apnea. They are also sometimes prescribed to combat fatigue in people who work shift work and also in other conditions such as multiple sclerosis. It is not known how modafinil/armodafinil promotes wakefulness. It appears to influence brain chemistry that increases wakefulness however the precise mechanism(s) is unknown. There are numerous side effects to these medications. Some more serious than others and some more likely than others. You can read about them in the TGA's product information: Modafinil or Armodafinil and also the consumer information leaflet Modafinil or Armodafinil. In this post we look specifically at modafinil/armodafinil and birth control and pregnancy. We hear from a number of women who are unaware of the potential failure of combined hormonal contraception, such as birth control pills, patches and implants when taken together with modafinil or armodafinil. Even more alarming are the number of doctors who also seem to be unaware of this information. Here are the facts: Contraception
A specific enzyme in the liver breaks down modafinil/armodafinil, which is then eliminated in the urine. The same enzyme that is responsible for clearing the body of modafinil/armodafinil also breaks down contraceptives. Studies have shown that, when taken together (contraceptives and either modafinil or armodafinil), the overall blood levels of contraceptives decrease by 18 percent, resulting in potentially significantly lower effectiveness of contraceptives . It is recommended that you should use an additional method of contraception while you are taking modafinil/armodafinil and for one month after discontinuing these medications. Pregnancy
Embryotoxic effects have been observed in some, but not all animal studies. There have never been adequate clinical trials in pregnant women to establish safety . This is from The Society for Women’s Health Research; "Like a lot of medications, modafinil (and armodafinil) is pregnancy category C, meaning animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled pregnancy outcome studies in humans. The potential benefits, though, may warrant use of the drug in pregnant women despite the potential harms . Therefore, it is important for both health care providers and women taking modafinil (or armodafinil) to avoid unplanned pregnancies while on the drug and to make an informed choice of continuing treatment only if the benefits outweigh the risks." While there have been no adequate clinical trials in humans, since writing this post TEVA Pharmaceuticals has recently reported on the results of the 2018 annual report of the ongoing Nuvigil/Provigil (modafinil) Pregnancy Registry in the United States. Please refer to the update below* Update 25/12/2018: A case study on the lack of significant transfer of modafinil from mum to baby via breastmilk was published in the Journal of Clinical Sleep Medicine in Dec 2018. “The relative infant dose was calculated to be 5.3%, below the threshold of concern for drug passage via breast milk.” Click here to read more. *Update 24/7/2019 URGENT ALERT REGARDING MODAFINIL AND PREGNANCY
TEVA Pharmaceuticals has recently reported on the results of the 2018 annual report of the ongoing Nuvigil/Provigil (modafinil) Pregnancy Registry in the United States. As a result French and Canadian health officials have recommended that pregnant women, and women who are trying to become pregnant, not take modafinil. The results suggested a higher rate of major congenital anomalies, and other adverse reactions, in children exposed to the drug in utero. This is from the Hypersomnia Foundation "According to our expert MAB member Prof. Arnulf, "they reported on 5 babies with abnormalities born from 75 women on modafinil. This is significantly larger than the usual 2% of spontaneous birth abnormalities without any drug. Despite the fact that some mothers were treated with combined drugs (which makes determination of specific causality difficult), and despite that the abnormal findings (not described in detail) were different from one baby to another, the French authorities last week firmly recommended stopping modafinil during pregnancy. Earlier data had been reassuring – the French database showed 60 prospective pregnancies on modafinil without any abnormalities, and the data from the German centers showed 28 pregnancies with no abnormal babies but some (not a statistically significant number) had smaller cranial perimeter. The French research center for teratogenicty (CRAT) indicates to be cautious with this new warning, but currently, it seems most prudent to stop using modafinil in current and future pregnancies." Health Canada has also recommended that women who are pregnant or who plan to become pregnant, not take modafinil. read more about the data and warning here. https://www.cbc.ca/news/health/alertec-modafinil-pregnancy-1.5183493 Always speak to your doctor about any concerns you have with your medications. And never purchase medications from anyone that isn't a registered pharmacist. Read our information "Beware of Rogue Online Drug Suppliers" here. Download a copy of our Factsheet HERE 1. Robertson P Jr1, Hellriegel ET, Arora S, Nelson M. Effect of modafinil on the pharmacokinetics of ethinyl estradiol and triazolam in healthy volunteers. Clin Pharmacol Ther. 2002 Jan;71(1):46-56.
2. Pregnancy and Medicine Fact Sheet: Office of Women’s Health https://www.womenshealth.gov/publications/our-publications/fact-sheet/pregnancy-medicines.html