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Provigil And Fertility

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Posted by Aralmaran on 2023-02-15

Critical revision of the manuscript for important intellectual content: All authors.

After some small studies, the reproductive safety of Modafinil use during pregnancy remains unclear. In this study, researchers analyzed data from pregnancies exposed to modafinil (Provigil) or armodafinil (Nuvigil) which were prospectively.

This study uses pharmacoepidemiology data from Danish national health registries to examine the association between first-trimester exposure to modafinil and risk of major congenital malformations. Modafinil is a stimulant Provigil And Fertility used in the treatment of excessive daytime sleepiness associated with narcolepsy. Modafinil has been discouraged during pregnancy because of a lack of safety data.

We examined the association between first-trimester exposure to modafinil and risk of major congenital malformations. We identified all pregnancies from to using the Danish national health registries. Modafinil exposure was defined as any prescription overlapping with the first trimester first 91 days of pregnancy. Duration of treatment was calculated by dividing amount prescribed with the standard daily defined dose of mg. The primary comparison click with pregnancies exposed to Fertilitg active comparator, methylphenidate, which is not associated with congenital malformations and is used for similar indications.

A second comparator group was pregnancies unexposed to modafinil and methylphenidate 1 Provigil And Fertility prior to and during pregnancy. Major malformations were identified during pregnancy, at delivery, or during the first year of life using the EUROCAT classification of malformations. Logistic regression was used to calculate odds ratios ORsadjusting for diagnosis of diabetes and hypertension, Fertioity use of psychotropic drugs listed in the Tablematernal age, year of delivery, smoking status, and body mass index.

First-Trimester Pregnancy Exposure to Modafinil and Risk of Congenital Malformations

Stata release Registry-based studies are exempt from informed consent and ethical review in Denmark. The study was approved by the Danish Data Health Authority. There were 49 pregnancies 0.

The adjusted ORs were 3. Those who were methylphenidate exposed are also compared with those who were unexposed. In this nationwide study, first-trimester in utero exposure to modafinil compared with methylphenidate or no medication was significantly associated with an increased risk of congenital malformations. In 2 case series totaling patients with narcolepsy, Provigil And Fertility malformations among 13 modafinil-exposed pregnancies were reported.

There are several limitations. First, the potential for residual confounding exists. For example, baseline differences in psychiatric medications were adjusted for, but adjusting for psychiatric was not feasible.

Modafinil and Armodafinil During Pregnancy: Data to Suggest Increased Risk of Malformations

Although methylphenidate was used as an active comparator to address confounding by indication, methylphenidate is indicated for ADHD Fertklity well as narcolepsy. Second, prescription redemptions were a proxy for actual use. Third, the small numbers of exposed women and events reflect the rarity of the exposure and decrease the precision of the point estimates. Fourth, specific malformations were not identifiable. Although further research is needed, women contemplating pregnancy should currently avoid or discontinue modafinil.

Modafinil and Armodafinil During Pregnancy: Data to Suggest Increased Risk of Malformations

Published online Jan Author information Article notes Copyright and License information Disclaimer. Corresponding author. Received Sep 26; Accepted Nov Copyright American Provigio Association.

All Rights Reserved. This article has been cited by other articles in PMC. After adjusting for potential confounders, modafinil was associated with a significantly increased risk for malformation compared to methylphenidate or no exposure. In the most recent study, researchers used Swedish and Norwegian birth registers to identify women using modafinil in pregnancy.

All singleton pregnancies resulting in live births were identified in the nationwide medical birth registers from Norway and Sweden In this cohort of nearly 2 million pregnancies, researchers used national prescribed drug registries to identify pregnancies exposed to modafinil during early pregnancy. Compared to pregnant women who had not received modafinil, pregnant women using modafinil were more likely to be overweight or obese, had higher rates of smoking, and were more likely to be diagnosed Provigil And Fertility narcolepsy, multiple sclerosis, or ADHD.

Overall, the rate of major malformations in Provgiil unexposed group was 2. In the modafinil group, there were three infants diagnosed with a major malformation, resulting in a prevalence rate of 2. While the most Provigil And Fertility data from Sweden and Norway are reassuring regarding the use of modafinil during pregnancy, one cannot ignore the data from the previous two reports which demonstrated very high rates of malformations among the children born to women taking modafinil.

While we do not know how many pregnancies were included in the original registry report, Anx the two other studies gives us exposed pregnancies. Based on these findings, we would be reluctant to support the use of modafinil during pregnancy. Ideally we would like to have data from exposures to get a better estimate of risk; basing decisions regarding safety on small sample sizes can lead to miscalculations of risk in either direction. Health Canada has issued the following recommendations regarding the use of modafinil.

Hopefully over the next year, we will have more data from the registry or other resources to help guide our decision making.

Modafinil may reduce the effectiveness of steroidal contraceptives, including oral contraceptives, through the induction of CYP3A4/5. Will Modafinil affect my fertility? There are no clinical trials to investigate whether Modafinil can affect fertility in humans, but animal studies show that.

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