PMID- 34564826
OWN - NLM
STAT- MEDLINE
DCOM- 20220225
LR  - 20220225
IS  - 2210-7711 (Electronic)
VI  - 44
IP  - 1
DP  - 2022 Feb
TI  - Descriptive analysis of reported adverse events associated with anti-obesity 
      medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020.
PG  - 172-179
LID - 10.1007/s11096-021-01330-2 [doi]
AB  - Background Obesity is a globally growing health problem, and its treatment has 
      been challenging. The use of anti-obesity medications (AOMs) has been associated 
      with severe adverse events (AEs). Several AOMs have been withdrawn from the 
      market owing to documented AEs. Aim To describe, estimate and characterize the 
      frequency of AEs attributable to the use of the AOMs, and investigate previously 
      unreported potential AEs associated with AOMs. Method Using the US FDA Adverse 
      Event Reporting System (FAERS) between January 2013 and June 2020, a 
      retrospective, descriptive analysis was conducted to analyze all major reported 
      AEs and outcomes including death, life-threatening, hospitalization, disability, 
      and required intervention or congenital anomaly. The total numbers of AEs 
      reports, cases, adverse reactions and outcomes were calculated for each 
      medication. Results A total of 18,675 unique AEs reports associated with AOMs 
      used for 15,143 patients. The mean age was 49.8 years [SD 1.83], while most 
      patients were female adults (73.4%). The most frequently reported AEs were nausea 
      and vomiting, followed by dizziness and headache, drug ineffectiveness, 
      cardiovascular diseases, and kidney complications. There were 21,229 unique 
      outcomes, including 1039 deaths (fatality ratio of 4.9% of all analyzed reports), 
      1613 (7.6%) life-threatening events, 7426 (35%) hospitalizations, and 1249 (5.9%) 
      disability cases. Phentermine/topiramate fatal cases represent 6% of the overall 
      medication's reported AEs. Cardiovascular AEs represented 31%, 23%, and 22% of 
      phentermine, liraglutide, and phentermine/topiramate total AEs, respectively. 
      Conclusion The analysis of FAERS database revealed numerous serious AEs 
      associated with AOMs. These AEs can lead to serious cardiovascular and kidney 
      complications. It is necessary to continue and systematically monitor safety of 
      AOMs' to optimize patient anti-obesity therapy.
CI  - (c) 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - Alsuhibani, Abdulrahman
AU  - Alsuhibani A
AUID- ORCID: 0000-0003-4852-1166
AD  - James L. Winkle College of Pharmacy, University of Cincinnati Academic Health 
      Center, Cincinnati, OH, 45267, USA. alsuhian@mail.uc.edu.
AD  - Department of Pharmacy Practice, Unaizah College of Pharmacy, Qassim University, 
      Unaizah, Saudi Arabia. alsuhian@mail.uc.edu.
FAU - Alrasheed, Marwan
AU  - Alrasheed M
AD  - James L. Winkle College of Pharmacy, University of Cincinnati Academic Health 
      Center, Cincinnati, OH, 45267, USA.
AD  - Department of Clinical Pharmacy, King Saud University College of Pharmacy, 
      Riyadh, Saudi Arabia.
FAU - Gari, Musaab
AU  - Gari M
AD  - James L. Winkle College of Pharmacy, University of Cincinnati Academic Health 
      Center, Cincinnati, OH, 45267, USA.
FAU - Hincapie, Ana L
AU  - Hincapie AL
AD  - James L. Winkle College of Pharmacy, University of Cincinnati Academic Health 
      Center, Cincinnati, OH, 45267, USA.
FAU - Guo, Jeff Jianfei
AU  - Guo JJ
AD  - James L. Winkle College of Pharmacy, University of Cincinnati Academic Health 
      Center, Cincinnati, OH, 45267, USA.
LA  - eng
PT  - Journal Article
DEP - 20210926
PL  - Netherlands
TA  - Int J Clin Pharm
JT  - International journal of clinical pharmacy
JID - 101554912
RN  - 0 (Anti-Obesity Agents)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Anti-Obesity Agents/adverse effects
MH  - Databases, Factual
MH  - *Drug-Related Side Effects and Adverse Reactions/diagnosis/epidemiology
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Obesity/drug therapy/epidemiology
MH  - Retrospective Studies
MH  - United States/epidemiology
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - Adverse events
OT  - Adverse reactions
OT  - Anti-obesity medications
OT  - Cardiovascular disease
OT  - Drug safety
OT  - Drug utilization
OT  - FDA Adverse Events Reporting System
OT  - Obesity
EDAT- 2021/09/27 06:00
MHDA- 2022/02/26 06:00
CRDT- 2021/09/26 21:11
PHST- 2021/06/21 00:00 [received]
PHST- 2021/09/14 00:00 [accepted]
PHST- 2021/09/27 06:00 [pubmed]
PHST- 2022/02/26 06:00 [medline]
PHST- 2021/09/26 21:11 [entrez]
AID - 10.1007/s11096-021-01330-2 [pii]
AID - 10.1007/s11096-021-01330-2 [doi]
PST - ppublish
SO  - Int J Clin Pharm. 2022 Feb;44(1):172-179. doi: 10.1007/s11096-021-01330-2. Epub 
      2021 Sep 26.