PMID- 37795911
OWN - NLM
STAT- MEDLINE
DCOM- 20240308
LR  - 20240308
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 23
IP  - 3
DP  - 2024 Mar
TI  - Characteristics of adverse drug reactions induced by flutamide and bicalutamide: 
      a real-world pharmacovigilance study using FAERS.
PG  - 305-311
LID - 10.1080/14740338.2023.2267978 [doi]
AB  - BACKGROUND: Flutamide and bicalutamide are indicated for the management of 
      prostate metastatic carcinoma. The current study evaluated the adverse drug 
      reactions related to flutamide and bicalutamide in a real-world setting. METHODS: 
      To quantify the signals of flutamide and bicalutamide associated adverse events 
      (AEs), we used the US Food and Drug Administration Adverse Event Reporting System 
      (FAERS) for this pharmacovigilance study using established pharmacovigilance 
      methods. RESULTS: A total of 2711 AEs of flutamide were investigated as the 
      primary suspected; 522 AEs were related to prostate cancer. A total of 4459 AEs 
      were investigated as the primary suspected for bicalutamide; 2251 AEs were 
      related to prostate cancer. The analysis demonstrated 29 signals for flutamide 
      and 84 for bicalutamide. Liver function test was the most common AEs for 
      flutamide, and malignant neoplasm progression was the most common for 
      bicalutamide. The signal strength of Dementia Alzheimer's type was 26.53 
      (17.89-39.35) and 26.33 (607.34), which had the highest strength for flutamide. 
      Anti-androgen withdrawal syndrome exhibited the strongest signal for 
      bicalutamide. Generating awareness of rare AEs that were not listed on the label 
      is critical. CONCLUSIONS: The analysis of the AE signals may provide support for 
      prescribing flutamide and bicalutamide.
FAU - Sun, Yu
AU  - Sun Y
AUID- ORCID: 0000-0001-5006-4852
AD  - Department of Pharmacy, The First Affiliated Hospital of Ningbo University, 
      Ningbo, China.
FAU - Xu, Tao
AU  - Xu T
AUID- ORCID: 0000-0001-5613-5287
AD  - Department of Pharmacy, The First Affiliated Hospital of Ningbo University, 
      Ningbo, China.
FAU - Zhu, Suyan
AU  - Zhu S
AUID- ORCID: 0000-0001-6704-3193
AD  - Department of Pharmacy, The First Affiliated Hospital of Ningbo University, 
      Ningbo, China.
FAU - Xu, Hongbin
AU  - Xu H
AUID- ORCID: 0000-0002-8406-9827
AD  - Department of Pharmacy, The First Affiliated Hospital of Ningbo University, 
      Ningbo, China.
LA  - eng
PT  - Journal Article
DEP - 20231016
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 76W6J0943E (Flutamide)
RN  - A0Z3NAU9DP (bicalutamide)
RN  - 0 (Anilides)
RN  - 0 (Nitriles)
RN  - 0 (Tosyl Compounds)
SB  - IM
MH  - Male
MH  - United States
MH  - Humans
MH  - Flutamide/adverse effects
MH  - Pharmacovigilance
MH  - United States Food and Drug Administration
MH  - *Prostatic Neoplasms/drug therapy/pathology
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - *Anilides
MH  - *Nitriles
MH  - *Tosyl Compounds
OTO - NOTNLM
OT  - FAERS
OT  - Flutamide
OT  - adverse events
OT  - bicalutamide
OT  - signal detection
EDAT- 2023/10/05 12:42
MHDA- 2024/03/08 06:43
CRDT- 2023/10/05 08:13
PHST- 2024/03/08 06:43 [medline]
PHST- 2023/10/05 12:42 [pubmed]
PHST- 2023/10/05 08:13 [entrez]
AID - 10.1080/14740338.2023.2267978 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2024 Mar;23(3):305-311. doi: 10.1080/14740338.2023.2267978. 
      Epub 2023 Oct 16.