PMID- 37170890
OWN - NLM
STAT- MEDLINE
DCOM- 20230816
LR  - 20230820
IS  - 1365-2125 (Electronic)
IS  - 0306-5251 (Linking)
VI  - 89
IP  - 9
DP  - 2023 Sep
TI  - Post-marketing safety concerns with nirmatrelvir: A disproportionality analysis 
      of spontaneous reports submitted to the FDA Adverse Event Reporting System.
PG  - 2830-2842
LID - 10.1111/bcp.15783 [doi]
AB  - AIMS: Nirmatrelvir is an antiviral drug with a novel mechanism of action, 
      targeting the 3-CL protease, and is used in the treatment of COVID-19. However, 
      the potential side effects have not yet been fully studied. The aim of this study 
      was to identify potential safety signals of nirmatrelvir by analysing 
      post-marketing safety data based on the largest publicly available worldwide 
      pharmacovigilance database. METHODS: We analysed nirmatrelvir adverse events to 
      identify and characterize relevant safety signals based on the FDA Adverse Event 
      Reporting System database in 2022. The case/non-case approach was used to 
      estimate the reporting odds ratio (ROR) and information component (IC) with 
      relevant confidence intervals (95% CI) for adverse events (AEs) that numbered 4 
      or more. RESULTS: A total of 26 846 cases were included. Disease recurrence (ROR 
      [95% CI] = 413.2 [395.6-431.59]), dysgeusia (ROR [95% CI] = 110.84 
      [106.04-115.85]), anosmia (ROR [95% CI] = 15.21 [12.76-18.11]), ageusia (ROR [95% 
      CI] = 9.80 [8.50-11.3]) and urticaria (ROR [95% CI] = 1.91 [1.69-2.17]) were the 
      main safety signals. In addition, abdominal pain upper and skin toxicity were two 
      specific safety signals of nirmatrelvir. In the pregnant population, there was a 
      significant increased ROR for life-threatening conditions (ROR [95% CI] = 8.00 
      [1.77-36.20]). CONCLUSIONS: Our study identified that the main and specific 
      safety signals of nirmatrelvir were disease recurrence, dysgeusia, abdominal pain 
      upper and skin toxicity. Clinicians and pharmacists should be vigilant of these 
      AEs, although differentiating between COVID-19 symptoms and AEs can be 
      challenging. Notably, a potential safety concern of nirmatrelvir should be a 
      warning based on a small number of events in the pregnant population. However, 
      the available data are insufficient, and further continued pharmacovigilance and 
      surveillance is needed to fully understand this issue.
CI  - (c) 2023 British Pharmacological Society.
FAU - Zhuang, Wei
AU  - Zhuang W
AUID- ORCID: 0000-0002-1720-8882
AD  - Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen 
      University, Xiamen, China.
FAU - Xu, Jiabing
AU  - Xu J
AD  - School of Pharmaceutical, Fujian University of Traditional Chinese Medicine, 
      Fuzhou, China.
FAU - Wu, Ye
AU  - Wu Y
AD  - Department of Ultrasound, The First Affiliated Hospital of Xiamen University, 
      Xiamen, China.
FAU - Yang, Jianhui
AU  - Yang J
AD  - Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen 
      University, Xiamen, China.
FAU - Lin, Xiuxian
AU  - Lin X
AD  - Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen 
      University, Xiamen, China.
FAU - Liao, Yufang
AU  - Liao Y
AD  - Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen 
      University, Xiamen, China.
FAU - Wan, Jun
AU  - Wan J
AD  - Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen 
      University, Xiamen, China.
FAU - Weng, Lizhu
AU  - Weng L
AD  - Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen 
      University, Xiamen, China.
FAU - Lin, Wanlong
AU  - Lin W
AD  - Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen 
      University, Xiamen, China.
LA  - eng
PT  - Journal Article
DEP - 20230525
PL  - England
TA  - Br J Clin Pharmacol
JT  - British journal of clinical pharmacology
JID - 7503323
SB  - IM
MH  - Humans
MH  - United States/epidemiology
MH  - Dysgeusia
MH  - Adverse Drug Reaction Reporting Systems
MH  - *COVID-19
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Pharmacovigilance
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - COVID-19
OT  - FAERS
OT  - nirmatrelvir
OT  - pharmacovigilance
OT  - pregnancy
OT  - safety signal
OT  - side effect
EDAT- 2023/05/12 13:08
MHDA- 2023/08/16 06:43
CRDT- 2023/05/12 06:12
PHST- 2023/04/15 00:00 [revised]
PHST- 2023/02/09 00:00 [received]
PHST- 2023/05/04 00:00 [accepted]
PHST- 2023/08/16 06:43 [medline]
PHST- 2023/05/12 13:08 [pubmed]
PHST- 2023/05/12 06:12 [entrez]
AID - 10.1111/bcp.15783 [doi]
PST - ppublish
SO  - Br J Clin Pharmacol. 2023 Sep;89(9):2830-2842. doi: 10.1111/bcp.15783. Epub 2023 
      May 25.