Medicines and Healthcare products Regulatory Agency (MHRA) issued warning to women using modafinil during pregnancy as increased risk of birth defects is identified with the drug.
Modafinil is a prescription-only medicine that is licensed only for the treatment of narcolepsy, a chronic disorder associated with sudden sleep that can cause serious disturbances to a patient’s quality of life.
As per MHRA press release:
- Modafinil (Provigil) causes an approximate 15% likelihood of birth defects when taken during pregnancy; this compares with 3% in the general population
- Evidence that modafinil also reduces effectiveness of oral contraception
- Healthcare professionals treating narcolepsy with modafinil are also being reminded of the need to ensure patients are taking effective measures to prevent pregnancy
This new advice is based on reports from a US study (of 61 babies exposed to modafinil in pregnancy) which showed that use of modafinil during pregnancy by women with narcolepsy possibly caused congenital malformations (including congenital heart defects, hypospadias, and orofacial clefts) in affected children.
Other side affects associated with modafinil are psychiatric disorders (depression, suicidal behaviours, and psychosis) serious skin reactions and cardiovascular disorders.
In United States, off label use of Modafinil includes brain booster, Military personnel, truck drivers, students, entrepreneurs, reported using the drug to sleep less and produce more.
2019, Health Canada issued a safety alert that modafinil use was contraindicated in women who are pregnant or may become pregnant due to the drug’s association with major fetal congenital malformations, including congenital cardiac abnormalities.
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