PMID- 35723868
OWN - NLM
STAT- MEDLINE
DCOM- 20220907
LR  - 20220908
IS  - 1179-6901 (Electronic)
IS  - 1174-5886 (Print)
IS  - 1174-5886 (Linking)
VI  - 22
IP  - 3
DP  - 2022 Sep
TI  - Analysis of the US Safety Data for Edaravone (Radicava((R))) From the Third Year 
      After Launch.
PG  - 205-211
LID - 10.1007/s40268-022-00391-6 [doi]
AB  - BACKGROUND: Amyotrophic lateral sclerosis (ALS) is a progressive and fatal 
      neuromuscular disease with no curative therapies. Edaravone (Radicava((R))) 
      (Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan), approved in the United 
      States (US) for ALS in adults in 2017, was shown in a clinical trial to slow the 
      rate of physical functional decline in ALS and is administered intravenously. The 
      aim of this paper is to summarize the observed safety profile from real-world 
      patient use during the first 3 years of edaravone availability in the US. 
      METHODS: Edaravone usage data were collected, and adverse events (AEs) were 
      identified from a postmarketing safety database from August 8, 2017 through 
      August 7, 2020 (cutoff date). RESULTS: As of October 3, 2020, 5207 ALS patients 
      had been treated with edaravone. As of August 7, 2020, the most commonly reported 
      AEs included death (not specified), drug ineffective, disease progression, 
      therapeutic response unexpected, fall, asthenia, fatigue, muscular weakness, gait 
      disturbance, and dyspnea. The most commonly reported serious AEs (SAEs) included 
      death (not specified), pneumonia, disease progression, ALS, fall, dyspnea, 
      respiratory failure, device-related infection, hospitalization, and 
      injection-site infection. There were 687 deaths, with 494 reported as death 
      without specifying the cause. Deaths were most commonly attributed to ALS, 
      disease progression, respiratory failure, or pneumonia. Review for 
      administration-site reactions revealed 95 AEs, including 34 site infections, with 
      22 SAEs (all non-fatal). Five non-fatal SAEs of anaphylaxis were reported. 
      CONCLUSION: In the postmarketing reporting to date, no new safety signals were 
      identified beyond those already known from the edaravone clinical trial program.
CI  - (c) 2022. The Author(s).
FAU - Genge, Angela
AU  - Genge A
AD  - Montreal Neurological Institute and Hospital, Montreal, Canada.
FAU - Brooks, Benjamin Rix
AU  - Brooks BR
AD  - Atrium Health Neurosciences Institute, Carolinas Medical Center, University of 
      North Carolina School of Medicine-Charlotte Campus, Charlotte, NC, USA.
FAU - Oskarsson, Bjorn
AU  - Oskarsson B
AD  - Mayo Clinic, Jacksonville, FL, USA.
FAU - Kalin, Alexander
AU  - Kalin A
AD  - Mitsubishi Tanabe Pharma Development America, Inc., Jersey City, NJ, USA.
FAU - Ji, Ming
AU  - Ji M
AD  - Mitsubishi Tanabe Pharma Development America, Inc., Jersey City, NJ, USA.
FAU - Apple, Stephen
AU  - Apple S
AUID- ORCID: 0000-0002-3051-3953
AD  - Mitsubishi Tanabe Pharma America, Inc., Jersey City, NJ, USA. 
      stephen_apple@mt-pharma-us.com.
FAU - Bower, Laura
AU  - Bower L
AD  - Mitsubishi Tanabe Pharma Development America, Inc., Jersey City, NJ, USA.
LA  - eng
PT  - Journal Article
DEP - 20220620
PL  - New Zealand
TA  - Drugs R D
JT  - Drugs in R&D
JID - 100883647
RN  - S798V6YJRP (Edaravone)
SB  - IM
MH  - Adult
MH  - *Amyotrophic Lateral Sclerosis/drug therapy
MH  - Disease Progression
MH  - Dyspnea/chemically induced
MH  - *Edaravone/adverse effects
MH  - Humans
MH  - Respiratory Insufficiency/chemically induced
MH  - United States
PMC - PMC9433633
COIS- AG, BRB, and BO are consultants for MTPA. BW, AK, MJ, and LB are employees of 
      Mitsubishi Tanabe Pharma Development America, Inc. SA is an employee of 
      Mitsubishi Tanabe Pharma America, Inc.
EDAT- 2022/06/21 06:00
MHDA- 2022/09/08 06:00
PMCR- 2022/06/20
CRDT- 2022/06/20 11:20
PHST- 2022/05/08 00:00 [accepted]
PHST- 2022/06/21 06:00 [pubmed]
PHST- 2022/09/08 06:00 [medline]
PHST- 2022/06/20 11:20 [entrez]
PHST- 2022/06/20 00:00 [pmc-release]
AID - 10.1007/s40268-022-00391-6 [pii]
AID - 391 [pii]
AID - 10.1007/s40268-022-00391-6 [doi]
PST - ppublish
SO  - Drugs R D. 2022 Sep;22(3):205-211. doi: 10.1007/s40268-022-00391-6. Epub 2022 Jun 
      20.