PMID- 34259127
OWN - NLM
STAT- MEDLINE
DCOM- 20211103
LR  - 20220427
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 20
IP  - 11
DP  - 2021 Nov
TI  - Safety profile of D-penicillamine: a comprehensive pharmacovigilance analysis by 
      FDA adverse event reporting system.
PG  - 1443-1450
LID - 10.1080/14740338.2021.1956460 [doi]
AB  - BACKGROUND: D-penicillamine (D-pen) is a copper-chelating drug and has 
      immune-modulatory properties. D-pen is used to treat rheumatoid arthritis, 
      Wilson's disease, and kidney stones (cystinuria). However, associated adverse 
      events (AEs) of D-pen treatment are frequent and often serious. Therefore, a 
      comprehensive assessment of the safety profile of D-pen is urgently needed. 
      RESEARCH DESIGN AND METHODS: We identified and analyzed AEs associated with D-pen 
      between April-1970 to July-2020 from the U.S. Food and Drug Administration 
      Adverse Event Reporting System (FAERS) databases and calculated the reported odds 
      ratio (ROR) with 95% confidence intervals (CI) using the disproportionality 
      analysis. RESULTS: A total of 9,150,234 AEs related to drugs were reported in the 
      FAERS database, of which 542 were related to D-Pen. We report that D-pen was 
      associated with dystonia (ROR: 20.52; 95%CI: 12.46-33.80), drug hypersensitivity 
      (ROR: 5.42; 95%CI: 3.72-7.90), pancytopenia (ROR: 10.20; 95%CI: 5.61-18.56), 
      joint swelling (ROR: 9.07; 95%CI: 5.51-14.94), renal-impairment (ROR: 6.68; 
      95%CI: 3.67-12.15), dysphagia (ROR: 5.05; 95%CI: 2.76-8.89), aggravation of 
      condition (ROR: 4.16; 95%CI: 2.60-6.67), congestive cardiac failure (ROR: 4.04; 
      95%CI: 2.22-7.35), peripheral edema (ROR: 3.77; 95%CI: 2.17-6.55), tremor (ROR: 
      3.46; 95%CI: 2.00-6.01), pyrexia (ROR: 3.46; 95%CI: 2.00-6.01), and gait 
      disturbance (ROR: 2.41; 95%CI: 1.29-4.52). CONCLUSIONS: Patients taking D-pen 
      require close monitoring of renal function, blood counts, immunity, liver, 
      cardiac function, and neurological function. D-pen suppresses immune system which 
      maximizes the risk of infection.
FAU - Kumar, Vijay
AU  - Kumar V
AUID- ORCID: 0000-0002-8035-9181
AD  - Department of Biotechnology, Yeungnam University, Gyeongsan, Republic of Korea.
FAU - Singh, Anand Prakash
AU  - Singh AP
AUID- ORCID: 0000-0002-9409-1366
AD  - Division of Cardiovascular Disease, Department of Medicine, University of Alabama 
      at Birmingham School of Medicine, Birmingham, AL, USA.
FAU - Wheeler, Nicholas
AU  - Wheeler N
AD  - Department of Biology, Western Kentucky University, Bowling Green, KY, USA.
FAU - Galindo, Cristi L
AU  - Galindo CL
AD  - Department of Biology, Western Kentucky University, Bowling Green, KY, USA.
FAU - Kim, Jong-Joo
AU  - Kim JJ
AD  - Department of Biotechnology, Yeungnam University, Gyeongsan, Republic of Korea.
LA  - eng
PT  - Journal Article
DEP - 20210726
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Chelating Agents)
RN  - GNN1DV99GX (Penicillamine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Aged
MH  - Chelating Agents/*adverse effects
MH  - Databases, Factual
MH  - Drug Monitoring/methods
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Penicillamine/*adverse effects
MH  - Pharmacovigilance
MH  - Retrospective Studies
MH  - United States
MH  - United States Food and Drug Administration
MH  - Young Adult
OTO - NOTNLM
OT  - D-penicillamine
OT  - FAERS
OT  - Wilson's disease
OT  - cystinuria
OT  - pharmacovigilance analysis
OT  - rheumatoid arthritis
EDAT- 2021/07/15 06:00
MHDA- 2021/11/04 06:00
CRDT- 2021/07/14 08:43
PHST- 2021/07/15 06:00 [pubmed]
PHST- 2021/11/04 06:00 [medline]
PHST- 2021/07/14 08:43 [entrez]
AID - 10.1080/14740338.2021.1956460 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2021 Nov;20(11):1443-1450. doi: 
      10.1080/14740338.2021.1956460. Epub 2021 Jul 26.