Information to Recommend Elevated Danger of Malformations




As quickly as we revealed this text on the usage of modafinil throughout being pregnant, one other examine was revealed which included knowledge 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 knowledge from ladies uncovered to modafinil and/or armodafinil inside 6 weeks previous to conception or throughout being pregnant.  Collected info is assessed as potential if enrollment happens earlier than data of the being pregnant consequence or detection of a congenital malformation via prenatal testing.  

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

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

These findings are much like these noticed in a Danish examine revealed in January of this yr which demonstrated a serious malformation price of 12% (n = 6) in 49 modafinil-exposed pregnancies.  Nevertheless, these knowledge and the present examine aren’t in line with a more moderen report from Sweden and Norway, which demonstrated an general threat of main malformations of two.3% (Three out of 133 uncovered pregnancies).  There may be not a selected sample of malformations related to publicity to modafinil, though it’s notable that Four of the 13 infants within the present examine had congenital torticollis, which is comparatively uncommon within the basic inhabitants and is a malformation not usually reported in these publicity research.  

Primarily based on these findings, we might not advocate the usage of modafinil or armodafinil throughout being pregnant.  Ideally we wish to have knowledge from 600-700 exposures to get a greater estimate of threat; basing selections relating to security on small pattern sizes can result in miscalculations of threat in both course.  Nonetheless, within the absence of sufficient knowledge, it might be clever to train warning when utilizing modafinil in ladies of reproductive age, on condition that half of all pregnancies are unplanned. In these conditions the place the usage of modafinil is indicated in a girl of reproductive age, efficient contraception is crucial.

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