Information to Recommend Elevated Danger of Malformations




As quickly as we printed this text on using modafinil throughout being pregnant, one other research was printed which included information on the reproductive security of modafinil and armodafinil from the US Provigil/Nuvigil Being pregnant Registry.  

The US Provigil/Nuvigil Being pregnant Registry was established in February 2010 and has collected information from girls uncovered to modafinil and/or armodafinil inside 6 weeks previous to conception or throughout being pregnant.  Collected data is assessed as potential if enrollment happens earlier than data of the being pregnant end result or detection of a congenital malformation via prenatal testing.  

On this research, researchers analyzed information from 148 pregnancies uncovered to modafinil (Provigil) or armodafinil (Nuvigil) which had been prospectively adopted (n = 122) or retrospectively ascertained (n = 26).  On this cohort, 81 girls obtained modafinil, 67 obtained armodafinil, and one affected person obtained each medication. Narcolepsy was indicated in 70% of prescriptions.  

Amongst  the 97 potential dwell births with first trimester cepsore, 13% (n = 13) had main malformations, which is effectively above the prevalence of about 3%-4% noticed within the common inhabitants.  Of those dwell births with malformations, Four had congenital torticollis, 2 had hypospadias, and three had congenital coronary heart defects.  Including within the retrospective instances didn’t change the prevalence of malformations.  

These findings are much like these noticed in a Danish research printed in January of this yr which demonstrated a serious malformation fee of 12% (n = 6) in 49 modafinil-exposed pregnancies.  Nonetheless, these information and the present research will not be according to a newer report from Sweden and Norway, which demonstrated an general danger of main malformations of two.3% (Three out of 133 uncovered pregnancies).  There’s not a particular sample of malformations related to publicity to modafinil, though it’s notable that Four of the 13 infants within the present research had congenital torticollis, which is comparatively uncommon within the common inhabitants and is a malformation not usually reported in these publicity research.  

Based mostly on these findings, we’d not advocate using modafinil or armodafinil throughout being pregnant.  Ideally we want to have information from 600-700 exposures to get a greater estimate of danger; basing selections relating to security on small pattern sizes can result in miscalculations of danger in both route.  Nonetheless, within the absence of sufficient information, it could be smart to train warning when utilizing modafinil in girls of reproductive age, on condition that half of all pregnancies are unplanned. In these conditions the place using modafinil is indicated in a lady of reproductive age, efficient contraception is crucial.

Necessary Reminder: Modafinil and armodafinil are inducers of the CYP-3A4 hepatic enzymes and enhance the metabolism of hormonal contraceptives, thus they might lower the effectiveness of hormonal contraception, together with contraception capsules, injections, implants, transdermal patches, and vaginal rings.   Girls who plan to take modafinil or armodafinil ought to be endorsed to make use of an alternate, simpler, methodology of contraception, comparable to a barrier methodology or an IUD.

 

Ruta Nonacs, MD PhD

 

Kaplan S, Braverman DL, Frishman I, Bartov N.  Being pregnant and Fetal Outcomes Following Publicity to Modafinil and Armodafinil Throughout Being pregnant.  JAMA Intern Med. 2020 Oct 19.

ALERTEC (modafinil) and the Danger of Congenital Anomalies (Well being Canada)

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