PMID- 37375814
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230701
IS  - 1424-8247 (Print)
IS  - 1424-8247 (Electronic)
IS  - 1424-8247 (Linking)
VI  - 16
IP  - 6
DP  - 2023 Jun 12
TI  - Uncovering Knowledge Gaps in the Safety Profile of Antiangiogenic Drugs in Cancer 
      Patients: Insights from Spontaneous Reporting Systems Studies.
LID - 10.3390/ph16060867 [doi]
LID - 867
AB  - Global repositories of postmarketing safety reports improve understanding of 
      real-life drug toxicities, often not observed in clinical trials. The aim of this 
      scoping review was to map the evidence from spontaneous reporting systems studies 
      (SRSs) of antiangiogenic drugs (AADs) in cancer patients and highlight if the 
      found disproportionality signals of adverse events (AEs) were validated and thus 
      mentioned in the respective Summary of product Characteristics (SmPC). This 
      scoping review was conducted according to PRISMA guidelines for scoping reviews. 
      A knowledge gap on the safety of AADs was found: firstly, several cardiovascular 
      AEs were not mentioned in the SmPCs and no pharmacovigilance studies were 
      conducted despite the well-known safety concerns about these drugs on the 
      cardiovascular system. Second, a disproportionality signal (not validated through 
      causality assessment) of pericardial disease was found in the literature for 
      axitinib with no mention in SmPC of the drug. Despite the exclusion of 
      pharmacoepidemiological studies, we believe that this scoping review, which 
      focuses on an entire class of drugs, could be considered as a novel approach to 
      highlight possible safety concerns of drugs and as a guide for the conduction of 
      a target postmarketing surveillance on AADs.
FAU - Ciccone, Valerio
AU  - Ciccone V
AUID- ORCID: 0000-0002-5374-9694
AD  - Department of Life Sciences, University of Siena, Via Aldo Moro 2, 53100 Siena, 
      Italy.
FAU - Ziche, Marina
AU  - Ziche M
AUID- ORCID: 0000-0002-9564-214X
AD  - Department of Medicine Surgery and Neuroscience, University of Siena, Viale Mario 
      Bracci 16, 53100 Siena, Italy.
FAU - Spini, Andrea
AU  - Spini A
AUID- ORCID: 0000-0001-7496-5575
AD  - Department of Medicine Surgery and Neuroscience, University of Siena, Viale Mario 
      Bracci 16, 53100 Siena, Italy.
AD  - Azienda Ospedaliera Universitaria Senese, Viale Mario Bracci 16, 53100 Siena, 
      Italy.
FAU - Donnini, Sandra
AU  - Donnini S
AUID- ORCID: 0000-0001-6617-1644
AD  - Department of Life Sciences, University of Siena, Via Aldo Moro 2, 53100 Siena, 
      Italy.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20230612
PL  - Switzerland
TA  - Pharmaceuticals (Basel)
JT  - Pharmaceuticals (Basel, Switzerland)
JID - 101238453
PMC - PMC10302288
OTO - NOTNLM
OT  - VEGF
OT  - adverse drug reaction
OT  - angiogenesis
OT  - disproportionality analysis
OT  - postmarketing surveillance
OT  - spontaneous reporting systems
COIS- The authors declare no conflict of interest.
EDAT- 2023/06/28 06:42
MHDA- 2023/06/28 06:43
PMCR- 2023/06/12
CRDT- 2023/06/28 01:35
PHST- 2023/05/13 00:00 [received]
PHST- 2023/06/08 00:00 [revised]
PHST- 2023/06/09 00:00 [accepted]
PHST- 2023/06/28 06:43 [medline]
PHST- 2023/06/28 06:42 [pubmed]
PHST- 2023/06/28 01:35 [entrez]
PHST- 2023/06/12 00:00 [pmc-release]
AID - ph16060867 [pii]
AID - pharmaceuticals-16-00867 [pii]
AID - 10.3390/ph16060867 [doi]
PST - epublish
SO  - Pharmaceuticals (Basel). 2023 Jun 12;16(6):867. doi: 10.3390/ph16060867.