Epilepsy
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EMA safety_alert · 2026-04-10Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2026
PRAC agreed to issue a communication to healthcare professionals about cases of severe liver injury linked to epilepsy medicines.
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EMA safety_alert · 2024-01-26Precautionary measures to address potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines
EMA safety precautionary measures advise restricting valproate use in men prior to conception due to possible risk of neurodevelopmental dis…
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EMA safety_alert · 2018-02-09PRAC recommends new measures to avoid valproate exposure in pregnancy
The PRAC recommends new measures to prevent valproate exposure during pregnancy due to risks of birth defects and developmental problems in …
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EMA safety_alert · 2017-07-11EMA seeks views of public during its safety review of valproate
EMA is seeking public input as part of its safety review of valproate, focusing on potential risks and safer use to protect patients, partic…
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CLINICAL_TRIALS safety_alert · 2016-11-25Clinical Trial Update: Risk of Urinary Retention With Retigabine
A terminated GlaxoSmithKline-sponsored trial evaluating retigabine in epilepsy has raised concerns about urinary retention. The update highl…
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EMA safety_alert · 2016-10-14EMA recommends measures to ensure safe use of Keppra oral solution
EMA recommends measures to ensure safe use of Keppra (levetiracetam) oral solution, addressing dosing and administration risks.
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CLINICAL_TRIALS safety_alert · 2014-10-01Clinical Trial Update: Birth Defects Associated With Exposure to Lamotrigine in Pregnancy (EUROCAT)
Clinical trial update noting birth defects associated with exposure to lamotrigine during pregnancy based on EUROCAT data.
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CLINICAL_TRIALS safety_alert · 2013-04-22Clinical Trial Update: Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures
Post-authorization safety study update assessing the safety of Vimpat (lacosamide) as add-on therapy in patients with partial-onset seizures…
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CLINICAL_TRIALS safety_alert · 2012-08-06Clinical Trial Update: WEUSKOP6166: Lamotrigine and Aseptic Meningitis
Clinical trial WEUSKOP6166 studying lamotrigine in epilepsy has an update related to aseptic meningitis risk. The safety signal centers on a…
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CLINICAL_TRIALS safety_alert · 2010-04-27Clinical Trial Update: A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures
This clinical trial update reports on the safety of topiramate when given in combination with other medications in adults and children with …