Modafinil drug adverse events associated with an increased risk of birth defects and reduced contraceptive effectiveness


Posted September 23, 2021 by karlpark733

Women taking modafinil have been warned of the increased risk of birth defects associated with modafinil use during pregnancy.
 
Modafinil (Provigil) causes approximately 15% chance of birth defects when taken during pregnancy; this compared to 3% of the general population
Evidence that modafinil also reduces the effectiveness of oral contraceptives
Healthcare professionals who treat narcolepsy with modafinil are also reminded of the need to ensure that patients take effective contraceptive measures
This warning comes from Medicines and Healthcare products Regulatory Agency (MHRA) following a careful review of the risks. The drug can also reduce the effectiveness of oral contraceptives. Women taking modafinil should take effective contraceptive measures and discuss their contraceptive methods with their health care professional.

This new advice is based on reports from a US study (of 61 children exposed to modafinil in pregnancy) that showed that the use of modafinil during pregnancy by women with narcolepsy may cause birth defects (including heart failure, hypospadias, and spinal cord injury). -orofacial) in affected children.

Modafinil is the only licensed medication for the treatment of narcolepsy, an incurable disease associated with sudden sleep that can cause serious disruption to a patient’s quality of life. As with any medication, there may be side effects associated with its use, including modafinil disorders (depression, suicidal ideation, and psychosis) severe skin reactions and heart disorders.

Dr Sarah Branch, director of MHRA's Vigilance and Risk Management of Medicines division said:

It is important for women to be aware of the increased risk of birth defects associated with taking modafinil during pregnancy.

Modafinil can reduce the effectiveness of many hormonal contraceptives, including the pill. Women should discuss their options with their health care professional and continue using their contraceptive methods for two months after discontinuing modafinil.

If you have any concerns, you should talk to your health care provider.

Patient safety is very important to us. We strongly encourage anyone to report any side effects, from this or any other medication, to our Yellow Card program.

Minister for Women's Health and Patient Safety Nadine Dorries said:

It is important for everyone to be aware of the possible side effects of any medication you are taking.

Modafinil should only be taken when prescribed by a health care professional to treat narcolepsy and it is important that all women who use it are aware of the potential risks including reducing the effectiveness of oral contraceptives and possible birth defects.

I urge all those taking modafinil to educate themselves about the side effects and potential risks, and to consult a health care professional if they are concerned.

Website: https://allmodafinil.com/
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Last Updated September 23, 2021