PMID- 35401230
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230904
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 13
DP  - 2022
TI  - Adverse Event Profiles of PARP Inhibitors: Analysis of Spontaneous Reports 
      Submitted to FAERS.
PG  - 851246
LID - 10.3389/fphar.2022.851246 [doi]
LID - 851246
AB  - Background: Several poly ADP ribose polymerase inhibitors (PARPis) are currently 
      approved for the treatment of a variety of cancers. The safety profile of PARPis 
      has not yet been systemically analyzed in the real world. We conducted this 
      pharmacovigilance analysis using the US FDA's Adverse Event Reporting System 
      (FAERS) database to explore the difference in adverse events (AEs) among PARPis. 
      Methods: FAERS data (December 2014 to October 2021) were searched for reports of 
      all FDA-approved PARPis across all indications. We used the standardized MedDRA 
      query (SMQ) generalized search AEs on the preferred term (PT) level based on case 
      reports. After filtering duplicate reports, disproportionality analysis was used 
      to detect safety signals by calculating reporting odds ratios (ROR). Reports were 
      considered statistically significant if the 95% confidence interval did not 
      contain the null value. Results: Within the standardized MedDRA queries, 
      significant safety signals were found, including those for olaparib [blood 
      premalignant disorders (ROR = 17.06)], rucaparib [taste and smell disorders (ROR 
      = 9.17)], niraparib [hematopoietic throbocytopenia (ROR = 28.2)], and talazoparib 
      [hematopoietic erythropenia (ROR = 9.38)]. For AEs on the PT level, we found 
      several significant signals, including platelet count decreased with niraparib 
      (ROR = 52.78); red blood cell count decreased with niraparib (ROR = 70.47) and 
      rucaparib (ROR = 15.09); myelodysplastic syndrome with olaparib (ROR = 35.47); 
      acute myeloid leukaemia with olaparib (ROR = 25.14); blood pressure fluctuation 
      with niraparib (ROR = 20.54); lymphangioleiomyomatosis with niraparib (ROR = 
      471.20); photosensitivity reaction with niraparib (ROR = 21.77) and rucaparib 
      (ROR = 18.92); renal impairment with rucaparib (ROR = 33.32); and interstitial 
      lung disease with Olaparib (ROR = 11.31). All the detected safety signals were 
      confirmed using signals of disproportionality reporting methods. Conclusion: 
      PARPis differed in their safety profile reports. The analysis of the FAERS 
      database revealed significant safety signals that matched previously published 
      case reports, including serious gastrointestinal, blood and lymphatic system, 
      cardiovascular and respiratory complications, which require individualized drug 
      administration according to patients' conditions.
CI  - Copyright (c) 2022 Tian, Chen, Gai, He, Jiang and Zhang.
FAU - Tian, Xiaojiang
AU  - Tian X
AD  - Department of Pharmacy, Chongqing Health Center for Women and Children, 
      Chongqing, China.
FAU - Chen, Lin
AU  - Chen L
AD  - Department of Pharmacy, Chongqing Health Center for Women and Children, 
      Chongqing, China.
FAU - Gai, Di
AU  - Gai D
AD  - Department of Pharmacy, Beijing Obstetrics and Gynecology Hospital, Capital 
      Medical University, Beijing Maternal and Child Health Care Hospital, Beijing, 
      China.
FAU - He, Sijie
AU  - He S
AD  - Department of Pharmacy, Maternal and Child Health Hospital of Hubei Province, 
      Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 
      China.
FAU - Jiang, Xuan
AU  - Jiang X
AD  - Department of Oncology, The Second Affiliated Hospital of Chongqing Medical 
      University, Chongqing, China.
FAU - Zhang, Ni
AU  - Zhang N
AD  - Department of Oncology, The Second Affiliated Hospital of Chongqing Medical 
      University, Chongqing, China.
LA  - eng
PT  - Journal Article
DEP - 20220325
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
CIN - Front Pharmacol. 2023 Aug 16;14:1241524. PMID: 37663271
PMC - PMC8990839
OTO - NOTNLM
OT  - FDA adverse events reporting system
OT  - PARP inhibitors
OT  - adverse events
OT  - reporting odds ratios
OT  - signal detection
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- 2022/04/12 06:00
MHDA- 2022/04/12 06:01
PMCR- 2022/03/25
CRDT- 2022/04/11 05:27
PHST- 2022/01/09 00:00 [received]
PHST- 2022/02/28 00:00 [accepted]
PHST- 2022/04/11 05:27 [entrez]
PHST- 2022/04/12 06:00 [pubmed]
PHST- 2022/04/12 06:01 [medline]
PHST- 2022/03/25 00:00 [pmc-release]
AID - 851246 [pii]
AID - 10.3389/fphar.2022.851246 [doi]
PST - epublish
SO  - Front Pharmacol. 2022 Mar 25;13:851246. doi: 10.3389/fphar.2022.851246. 
      eCollection 2022.