Dear Doctor Letter (Rote-Hand-Brief) on modafinil: potential risk of severe congenital malformations
2019.05.09
Active substance: modafinil
In coordination with the Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of medicinal products containing modafinil inform about new findings related to the use of modafinil during pregnancy. It is suspected that the use of Modafinil during pregnancy can lead to severe congenital malformations. Modafinil should therefore not be used during pregnancy. Patients of childbearing age who are treated with Modafinil must use an effective method of contraception.
Risk information (available in German only)
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