Drug Safety Monitoring—International Information

• Main Authors: E. V. Shubnikova, T. M. Bukatina, G. V. Kutekhova
• Format: Article
• Language: Russian
• Published: Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation 2020-12-01
• Series: Безопасность и риск фармакотерапии
• Subjects: adverse reactions; postmarketing studies; safety profile; drugs; patient information leaflet; pharmacovigilance
• Online Access: https://www.risksafety.ru/jour/article/view/204

Experts of the Department for Evaluation of Medicinal Products’ Safety of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on limiting the use of some medicinal products and/or the need to introduce changes in patient information leaflets due to changes in the medicines’ safety profiles. The analysis helped to identify 16 administrative decisions that contain information on the following medicines registered in Russia: duloxetine, sertraline, paroxetine, сitalopram, desvenlafaxine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, venlafaxine, vortioxetine, mirtazapine, risperidone, clozapine, aripiprazole, quetiapine, olanzapine, lacosamide, gabapentin, pregabalin.