Post-marketing safety of CGRP monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data - PubMed
4 hours ago
- #pharmacovigilance
- #CGRP inhibitors
- #drug safety
- CGRP inhibitors, including monoclonal antibodies (mAbs) and gepants, have transformed migraine treatment.
- Post-marketing surveillance is essential for understanding their real-world safety profile.
- Systematic review of 30 studies identified safety signals from databases like FAERS, VigiBase, and EudraVigilance.
- mAbs showed signals for injection site reactions, alopecia, constipation, and cardiovascular events.
- Gepants were linked to nausea, fatigue, and specific issues like dysgeusia for zavegepant.
- Rare but serious cerebrovascular events like RCVS and CeAD were associated with some mAbs but not gepants.
- Shared adverse effects across both subclasses include Raynaud's phenomenon and alopecia.
- Safety in pregnancy data is complex, warranting further dedicated studies.
- CGRP inhibitors have a manageable yet complex safety profile, requiring personalized risk assessment.