Preliminary Data Raises Concerns About Modalert Use in Pregnancy

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Modalert Use and Birth Defects

A new study published this week in JAMA Psychiatry raises concerns about the wake-promoting drug Modalert 200mg and its possible links to birth defects. The Danish researchers analyzed data from healthcare registries on pregnancies where women received modafinil or the similar stimulant armodafinil in the first trimester of pregnancy. They compared the results with data from nearly 830,000 pregnancies that did not receive either drug. The authors found that infants born to mothers who took Modalert had a 2.6% higher risk of malformation than those babies who did not. This is about twice as high as the risk observed in earlier studies of narcolepsy and MS-related fatigue but is lower than the reported risks for pregnant women who take other prescription drugs such as metformin and tetracycline.

The authors also looked at individual cases of major congenital defects that occurred in the offspring of mothers who took modafinil or armodafinil, such as cleft palate and omphalocele, both of which can cause deformities of the face and body. They also looked at genital defects such as hypospadias, which occur when the opening of the urethra does not form properly and isn’t at the tip of the penis. They found that none of these cases was linked to the mother’s use of modafinil or armodafinil, but three were linked with maternal exposure to the stimulant methylphenidate.

Health Canada has already issued a warning for Canadian women who may be taking Provigil or Nuvigil after discovering they are pregnant. This was based on a review of animal data showing reproductive toxicity with the drug, as well as reports from a registry that was established in 2010 to characterize pregnancy and fetal outcomes associated with Provigil and Nuvigil exposure (the U.S. FDA has a Nuvigil/Provigil Pregnancy Registry). The MHRA statement advised healthcare professionals to discuss the risks with female patients of childbearing potential and to ensure that they use effective contraception during treatment and for two months after stopping the medication.

It also said that Modalert 200mg can decrease the effectiveness of hormonal contraceptives, so patients should not stop using their pill until they are sure that they do not intend to become pregnant. It advised those who do not want to get pregnant to consider long-term contraception methods such as the copper intrauterine device or levonorgestrel-releasing intrauterine system.

Modalert Use and Microcephaly

The manufacturer of Provigil and Nuvigil, Teva Canada Innovation, has recently released data from a pregnancy registry that shows there is a 15% risk of major congenital malformations in children born to mothers who took the drug in utero. These findings were based on a registry of pregnant women who used the Modalert medication to treat narcolepsy and other sleep disorders. They were compared with pregnancies of women who were given methylphenidate, a medication used to treat attention deficit hyperactivity disorder (ADHD) and which is not associated with congenital malformations.

The most serious birth defects caused by Provigil and Nuvigil use are microcephaly. This condition causes the child’s head to be smaller than it should be and can lead to severe developmental issues. Children with this defect may suffer seizures, difficulty walking or sitting, and trouble eating or hearing.

Other complications include problems with the urethra or urinary tract. Specifically, the opening of the urethra can form on the shaft of the penis (sub coronal), near where the penis meets the scrotum (pen scrotal), or at the top of the urethra where it attaches to the bladder (transverse urethral). This can cause problems with urinating and can also lead to infertility later in life.

There are also reports of a link between Provigil and Vilafinil use in pregnancy and hypospadias, which is a condition where the urethral opening forms in the place where the penis and scrotum join (transverse urethral). This is typically treated with surgery.

In addition to these issues, there are concerns that Modalert and Vilafinil use in a woman’s first trimester can increase the risk of heart defects in her baby. This was based on a retrospective study using Danish national health registries that looked at women who were exposed to Vilafinil in the first trimester of their pregnancy and compared them with a group that was not exposed to the drug.

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