PMID- 38264523
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240125
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 14
DP  - 2023
TI  - Adverse event reporting of four anti-Calcitonin gene-related peptide monoclonal 
      antibodies for migraine prevention: a real-world study based on the FDA adverse 
      event reporting system.
PG  - 1257282
LID - 10.3389/fphar.2023.1257282 [doi]
LID - 1257282
AB  - Background: Anti-Calcitonin gene-related peptide monoclonal antibodies (anti-CGRP 
      mAbs) have shown significant efficacy in preventing migraine. However, there have 
      been limited reports of adverse events (AEs) after marketing, particularly for 
      eptinezumab launched in 2020. The study aimed to mine and analyze the AE signals 
      with four anti-CGRP mAbs from the United States Food and Drug Administration 
      (FDA) Adverse Event Reporting System (FAERS) database to gain insights into the 
      safety profile of these medications post-marketing. Methods: All AE reports on 
      the four anti-CGRP mAbs (erenumab, galcanezumab, fremanezumab, and eptinezumab) 
      were retrieved from the FAERS database from the first quarter (Q1) of 2018 to Q1 
      of 2023. Disproportionality analysis was measured by reporting odd ratio (ROR) 
      and Bayesian confidence propagation neural network (BCPNN) to identify potential 
      AE signals. Comparisons were made between the four drugs in terms of AEs. 
      Results: A total of 38,515 reports of erenumab, 19,485 reports of galcanezumab, 
      5,332 reports of fremanezumab, and 2,460 reports of eptinezumab were obtained, 
      mostly reported in the second to third year after launch in the market. The 
      common AEs to erenumab included constipation (17.93%), injection site pain 
      (14.08%), and alopecia (7.23%). The AEs that occurred more frequently with 
      galcanezumab included injection site pain (24.37%), injection site erythema 
      (5.35%), and injection site haemorrhage (4.97%). Common AEs related to 
      fremanezumab were injection site pain (13.10%), injection site erythema (7.02%), 
      and injection site pruritus (5.47%). Fatigue (13.54%), throat irritation (9.02%), 
      and pruritus (8.20%) were the most common AEs with eptinezumab. In addition, 
      there are new AEs that were not listed in the drug instructions but occurred 
      concurrently with multiple drugs, such as Raynaud's phenomenon, weight increase, 
      menstrual disorders, throat tightness, and paraesthesia oral. Conclusion: Common 
      AE signals of the four anti-CGRP mAbs and new AE signals were found to provide a 
      reference for clinical drug selection in clinical practice.
CI  - Copyright (c) 2024 Sun, Li, Xia, Chen, Liu, Pang, Liu and Cheng.
FAU - Sun, Wenfang
AU  - Sun W
AD  - Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, 
      Beijing, China.
FAU - Li, Yali
AU  - Li Y
AD  - Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, 
      Beijing, China.
FAU - Xia, Binbin
AU  - Xia B
AD  - Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, 
      Beijing, China.
FAU - Chen, Jing
AU  - Chen J
AD  - Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, 
      Beijing, China.
FAU - Liu, Yang
AU  - Liu Y
AD  - Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, 
      Beijing, China.
FAU - Pang, Jingyao
AU  - Pang J
AD  - Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, 
      Beijing, China.
FAU - Liu, Fang
AU  - Liu F
AD  - Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, 
      Beijing, China.
FAU - Cheng, Hua
AU  - Cheng H
AD  - Department of Pharmacy, Beijing Luhe Hospital, Capital Medical University, 
      Beijing, China.
LA  - eng
PT  - Journal Article
DEP - 20240109
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC10803415
OTO - NOTNLM
OT  - Calcitonin gene-related peptide
OT  - FDA adverse events reporting system
OT  - adverse events
OT  - migraine
OT  - safety
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2024/01/24 06:42
MHDA- 2024/01/24 06:43
PMCR- 2024/01/09
CRDT- 2024/01/24 03:53
PHST- 2023/07/19 00:00 [received]
PHST- 2023/12/22 00:00 [accepted]
PHST- 2024/01/24 06:43 [medline]
PHST- 2024/01/24 06:42 [pubmed]
PHST- 2024/01/24 03:53 [entrez]
PHST- 2024/01/09 00:00 [pmc-release]
AID - 1257282 [pii]
AID - 10.3389/fphar.2023.1257282 [doi]
PST - epublish
SO  - Front Pharmacol. 2024 Jan 9;14:1257282. doi: 10.3389/fphar.2023.1257282. 
      eCollection 2023.