The Medicines and Healthcare products Regulatory Agency (MHRA) in conjunction with Nadine Dorries, the Minister for Patient Safety, Suicide Prevention and Mental Health issued a warning to women using Modafinil, a drug used for sleep disorders, of an increased risk of birth defects associated with the drug's use during pregnancy.
The warning published on the MHRA website explains that Modafinil (Provigil) causes an approximate 15 per cent likelihood of birth defects when taken during pregnancy. This compares with a three per cent risk in the general population.
There is also evidence that Modafinil also reduces effectiveness of oral contraception.
Teva Pharmaceuticals, Ireland first made a direct communication to healthcare professionals in June 2019 that an interim analysis of post marketing surveillance data detected major malformations as set out above. The communication confirmed that:
- Modafinil should not be used during pregnancy
- Women of childbearing potential must use effective contraception during treatment with, and for two months after stopping Modafinil
- All female patients of childbearing potential should be informed of and fully understand the above
- The need to discuss other treatment options with a doctor if planning a pregnancy before stopping contraception
- Non-pharmacological treatment options including behaviour modifying measures, sleep hygiene, and scheduled daytime naps should be preferred during pregnancy
This advice about the drug is based on reports from a US study of 61 babies exposed to Modafinil in pregnancy which showed that use of the drug during pregnancy by women with narcolepsy possibly caused congenital malformations including congenital heart defects, hypospadias, and orofacial clefts in affected children.
The Patient Information Leaflet, from June 2019 which should be provided with the drug, confirms the above.
Dr Sarah Branch, director of MHRA's Vigilance and Risk Management of Medicines division said:
"It is important that women are aware of the increased risk of congenital malformations associated with taking modafinil during pregnancy."
She went on to confirm that "patient safety is our highest priority. We strongly encourage anyone to report any side effects, from this or any medicine, to our Yellow Card scheme."
Currently the regulator, the MHRA can be months behind in putting warnings on their website about the safety concerns surrounding drugs or medical devices. Healthcare professionals and patients are being advised to regularly check the Patient Information Leaflets or the BNF prescribing guidelines to ensure that the potential adverse side-effects of the medicines being prescribed are relayed to a patient as soon as possible.
Leigh Day consumer and product safety lawyer, Zahra Nanji said:
"The problems highlighted by the MHRA are reminiscent of the concerns raised with the notorious Thalodomide and Sodium Valproate (Epilim) an epilepsy drug, which can also cause congenital birth defects when taken during pregnancy and begs the question how can another teratogenic drug have with been allowed on the market without sufficient warnings.
"The risks of taking the drug do not outweigh the benefits especially where there are safer alternative therapies for sleep disorders on the market. Those that been affected by the drug are therefore entitled to compensation if they have not had proper counselling and consenting as to the most appropriate drug for them and their circumstances."
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