Ireland Health authority, Health Products Regulatory Authority – HPRA has released a drug safety alert for modafinil association with congenital malformations (congenital heart defects, hypospadias and orofacial clefts) in foetus when exposed to a pregnant woman or to women of childbearing potential.

Modafinil is a wakefulness promoting medicinal product used in the treatment of too much of sleepiness which may happen with obstructive sleep apnea, narcolepsy, and shift work sleep disorders

Bluefish Pharmaceuticals, the marketing authorisation holder (MAH) for modafinil with the brand names Nuvigil® and Provigil® published a “Direct Healthcare Professional Communication (DHPC)” to all the relevant stakeholders, health authorities and health care professionals to alert on the potential risk of congenital malformation in the newly born babies when a women exposed to this medicinal product during pregnancy or product used by a women of childbearing potential. MAH identified this alert based on the review of safety evidence from the postmarketing case reports, pregnancy registries, spontaneous case reports having modafinil and its corresponding brand products as suspected medicinal product.

Significant information from pregnancy registries – Nuvigil® and Provigil®

This registry is a prospective, observational study conducted in the United States to characterize the outcomes of pregnancy and fetus following exposure with modafinil from six weeks prior to conception and/or during pregnancy. The primary endpoint for this registry is major birth defects (structural and functional birth defects) identified in the perinatal period through 12 months of life.

From the registry, major congenital malformations including congenital heart defects, hypospadias and orofacial clefts are reported with a causal relationship to modafinil. The annual registry report that the rate of major congenital malformations was approximately 15% compared to 3% in the general population.

Important information for health care professionals & patients:

  • Be aware of potential risk of congenital malformations to foetus associated with modafinil use during pregnancy.
  • Women of childbearing potential must use effective contraception during treatment with, and for 2 months after stopping, modafinil.
  • Do not use modafinil during pregnancy.
  • Modafinil reduces the effectiveness of oral contraception. Women of childbearing potential using modafinil are advised to use alternative methods of contraception.
  • Patients/patient care providers are advised to discuss all the relevant current medical conditions, medicines used prior/concomitantly for effective benefit risk analysis.

Voluntary ADR reporting

All health care professionals and consumers are encouraged to observe and monitor for safety outcomes of medicinal products used during pregnancy in order to accumulate safety evidence for medicinal products in these special population groups who are not included/studied during clinical trial period. If you experience any adverse reaction or event which is suspected to the use of any drug during pregnancy, report the same to Health Products Regulatory Authority – HPRA, via online voluntary ADR reporting page.

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