UK Medicines Information
European Medicines Agency recommends measures to reduce risk of heart problems with ivabradine
Information type:
Safety alerts
Source:
European Medicines Agency
Specialities:
Cardiovascular system disorders
Summary
EMA has made recommendations aimed at reducing risk of cardiac problems with ivabradine. This follows review of final data from SIGNIFY study which showed small increase in combined risk of CV death/non-fatal MI compared with placebo in a subgroup with symptomatic angina.
UKMi comment
Following this EU decision, MHRA guidance may be issued in due course.
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