A list of the pregnancy registries and large databases is provided below. • Based on post-marketing reports from the US Nuvigil and Provigil Pregnancy Registry and other spontaneous sources, use of modafinil during pregnancy is suspected to cause congenital malformations (including congenital heart defects, hypospadias, and orofacial clefts) • Of the 78 prospective pregnancy cases identified within the registry, 61 cases reported a live birth outcome, 9 of … In the unexposed group, the rate of major malformations was 2.1 percent. Summary . Pregnancy Registry: There is a registry for women who become pregnant during treatment with PROVIGIL. FDA does not endorse any registry … To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. A total of 45 distinct registries were identified. Three modafinil-exposed infants were diagnosed with a major malformation, for a prevalence rate of 2.6 percent and a crude risk ratio of 1.06 (95 percent confidence interval, 0.35 to 3.26). Large birth registry study conducted in Norway and Sweden did not show link to major malformationsFRIDAY, Sept. 11, 2020 (HealthDay News) -- Modafinil use during early pregnancy is not associated with significantly increased risk for major malformations in exposed infants, according to a research letter published online Sept. 1 in the Carolyn E. Cesta, Ph.D., from the Karolinska Institutet in Stockholm, and colleagues identified all singleton pregnancies resulting in live births in nationwide medical birth registers in Norway and Sweden to examine the association between modafinil use in early pregnancy and major malformations in exposed infants.Overall, 133 of the 1,917,605 pregnancies were exposed to modafinil during early pregnancy. The researchers found that pregnant women who had taken modafinil were more often overweight or obese and had higher rates of smoking and diagnoses of narcolepsy, multiple sclerosis, and attention-deficit/hyperactivity disorder. There are two known cases of intrauterine growth retardation with the use of modafinil in pregnancy. Modafinil use during early pregnancy is not associated with significantly increased risk for major malformations in exposed infants, according to a research letter published online Sept. 1 in the Journal of the American Medical Association. Contact the registry as soon as you learn that you are pregnant, or ask your doctor to contact the registry for you. There is a registry for women who become pregnant during treatment with PROVIGIL. As far as I know, the FDA has not issued a specific warning regarding the use of modafinil during pregnancy.
The researchers found that pregnant women who had taken modafinil were more often overweight or obese and had higher rates of smoking and diagnoses of narcolepsy, multiple sclerosis, and attention-deficit/hyperactivity disorder. Modafinil in Early Pregnancy Not Tied to Congenital Malformations. In the unexposed group, the rate of major malformations was 2.1 percent. Large birth registry study conducted in Norway and Sweden did not show link to major malformations. On restriction to filled prescriptions during the first trimester, 75 pregnancies were exposed and one major malformation was identified in a modafinil-exposed infant (risk ratio, 0.44; 95 percent confidence interval, 0.06 to 3.10).
FRIDAY, Sept. 11, 2020 (HealthDay News) -- Modafinil use during early pregnancy is not associated with significantly increased risk for major malformations in exposed infants, according to a research letter published online Sept. 1 in the Carolyn E. Cesta, Ph.D., from the Karolinska Institutet in Stockholm, and colleagues identified all singleton pregnancies resulting in live births in nationwide medical birth registers in Norway and Sweden to examine the association between modafinil use in early pregnancy and major malformations in exposed infants.Overall, 133 of the 1,917,605 pregnancies were exposed to modafinil during early pregnancy. Modafinil in Early Pregnancy Not Tied to Congenital Malformations Last Updated: September 11, 2020. To discover more about the potential risks of modafinil use during pregnancy, researchers at Karolinska Institutet in Sweden and the Norwegian Institute of Public Health have now conducted a much larger study using data from each country's health registries.
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