MHRA Drug Safety Update
June 2024
Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child. Harms included a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder in children of mothers taking topiramate during pregnancy.
Taking warfarin and tramadol together can cause harmful drug interactions, which can raise the International Normalised Ratio (INR), and result in severe bruising and bleeding, which in some patients could be fatal.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Drug Safety Update is a monthly newsletter from the Medicines and Healthcare products Regulatory Agency (MHRA) and its independent advisor the Commission on Human Medicines.
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