Sleep disorder drug modafinil linked to increased risk of birth defects

'This new advice is based on reports from a study conducted in the US, which observed 61 babies that were exposed to modafinil during pregnancy'

From Health Europa website: The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning to people using the sleep disorder drug modafinil while pregnant, due to an association with increased risk of birth defects.

Modafinil is a prescription-only medicine that is licensed for the treatment of narcolepsy, a rare long-term brain condition that causes excessive daytime sleepiness, cataplexy (loss of muscle tone), and sleep disturbance. However, it is often used off-label as a study drug, as well as a treatment for conditions such ADHD, SAD and depression.

As with any drug, there can be side effects associated with modafinil, including psychiatric disorders, serious skin reactions and cardiovascular disorders.

This new advice is based on reports from a study conducted in the US, which observed 61 babies that were exposed to modafinil during pregnancy. Results indicated that modafinil possibly caused congenital malformations (including congenital heart defects, hypospadias, and orofacial clefts) in affected children. The likelihood of birth defects when modafinil was taken during pregnancy is approximately 15%, compared to 3% of the general population.

There is also evidence that modafinil may reduce the effectiveness of steroidal contraceptives, including oral contraceptives. Therefore, alternative, or concomitant methods of contraception are being recommended to women taking modafinil for narcolepsy treatment....