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June 27, 2019
This is an important alert for pregnant women and women capable of childbearing who are taking or have recently taken the stimulant drugs modafinil (PROVIGIL) or armodafinil (NUVIGIL).
Earlier this month, drug regulators in Canada (Health Canada)[1] and Ireland (Health Products Regulatory Authority)[2] issued notices to health care professionals regarding evidence of an increased risk of congenital birth defects associated with use of modafinil and armodafinil.
The...
June 27, 2019
This is an important alert for pregnant women and women capable of childbearing who are taking or have recently taken the stimulant drugs modafinil (PROVIGIL) or armodafinil (NUVIGIL).
Earlier this month, drug regulators in Canada (Health Canada)[1] and Ireland (Health Products Regulatory Authority)[2] issued notices to health care professionals regarding evidence of an increased risk of congenital birth defects associated with use of modafinil and armodafinil.
The notices warned that modafinil should never be used by women who are or may become pregnant. They also emphasized the need for a negative pregnancy test within one week of starting modafinil and for effective contraception during treatment with the drug and for two months after stopping it.
Importantly, the notices also warned that modafinil may reduce the effectiveness of oral contraceptives. Therefore, alternative or additional contraceptive methods are required for women during treatment with modafinil and for two months after stopping the drug.
Modafinil and armodafinil are stimulant drugs with nearly identical chemical makeups. Both are approved by the Food and Drug Administration (FDA) for improving wakefulness in adults with excessive sleeping associated with narcolepsy (a neurological condition characterized by an extreme uncontrollable tendency to fall asleep during the day), obstructive sleep apnea (repeated blocking of the upper airway during sleep) and shift work disorder (excessive sleepiness and insomnia in people who work shifts or irregular schedules during the typical sleep period).[3],[4]
The Canadian and Irish regulators issued their notices after Teva, the maker of these drugs, informed them of the most recent results from an ongoing U.S. registry study that was created to monitor for birth defects in children of mothers who used either drug during pregnancy. The registry was established at the request of the FDA because of prior evidence of fetal toxicity in animal studies of modafinil and armodafinil.[5]
The most recent results from the armodafinil and modafinil registry documented cases of spontaneous abortion and major birth defects, including heart defects in the fetuses of women taking these drugs.[6] Specifically, major congenital birth defects occurred in the fetuses of 17% of the women in this registry compared with 3% of those of pregnant women in the general population. In addition, heart defects occurred in the fetuses of 4% of the pregnant women in this registry, compared with 1% of those of pregnant women in the general population. Notably, other reports have linked these drugs to low fetal growth and poor physical development among babies of women who used the drugs during pregnancy.
The warnings in these notices were limited to modafinil because armodafinil is not marketed in Canada or the European Union. However, the restrictions on modafinil also apply to armodafinil.
At press time, the FDA has not yet issued similar warnings about these drugs to U.S. health care professionals. The current labeling of modafinil and armodafinil only include a general warning that animal data suggest that these drugs may cause fetal harm.
What You Can Do
Do not use modafinil or armodafinil if you are a woman who is currently pregnant or may become pregnant. Women capable of childbearing who opt to use these drugs should use effective contraception (other than or in addition to oral contraceptives, if applicable) when taking these drugs and for two months after stopping them.
To see announcement by Health Canada, visit the following link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70201a-eng.php.
To see the announcement by the Irish Health Products Regulatory Authority, visit the following link: https://www.hpra.ie/homepage/medicines/safety-notices/item?t=/modafinil---important-safety-information-from-teva-pharmaceuticals-ireland-clonmel-healthcare-ltd-and-fannin-limited-as-approved-by-hpra&id=ad170c26-9782-6eee-9b55-ff00008c97d0.
References
[1] Health Canada. Recalls and safety alerts: ALERTEC (modafinil) and the risk of congenital anomalies. June 20, 2019. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70201a-eng.php. Accessed June 27, 2019.
[2] Health Products Regulatory Authority. Modafinil - Important safety information from Teva Pharmaceuticals Ireland, Clonmel Healthcare Ltd and Fannin Limited as approved by HPRA. June 11, 2019. https://www.hpra.ie/homepage/medicines/safety-notices/item?t=/modafinil---important-safety-information-from-teva-pharmaceuticals-ireland-clonmel-healthcare-ltd-and-fannin-limited-as-approved-by-hpra&id=ad170c26-9782-6eee-9b55-ff00008c97d0. Accessed June 27, 2019.
[3] Cephalon, Inc. Label: armodafinil (NUVIGIL). November 2018. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d878aed0-ddbf-8fa1-abf7-d3e480260845&type=display. Accessed June 27, 2019.
[4] Cephalon, Inc. Label: modafinil (PROVIGIL). November 2018. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e16c26ad-7bc2-d155-3a5d-da83ad6492c8&type=display. Accessed June 27, 2019.
[5] Teva Pharmaceuticals. NUVIGIL pregnancy registry. http://www.nuvigilpregnancyregistry.com/. Accessed June 27, 2019.
[6] Health Canada. Recalls and safety alerts: ALERTEC (modafinil) and the risk of congenital anomalies. June 20, 2019. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70201a-eng.php. Accessed June 27, 2019.
