Evidence map›Paper›PMID 34564826›Full record

ArticleInternational journal of clinical pharmacy2022

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020.

Abdulrahman Alsuhibani, Marwan Alrasheed, Musaab Gari, Ana L Hincapie, Jeff Jianfei Guo

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Article in International journal of clinical pharmacy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 2 countries.

Abdulrahman AlsuhibaniJames L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH, 45267, USA. alsuhian@mail.uc.edu.ORCID http://orcid.org/0000-0003-4852-1166
Marwan AlrasheedJames L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH, 45267, USA.
Musaab GariJames L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH, 45267, USA.
Ana L HincapieJames L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH, 45267, USA.
Jeff Jianfei GuoJames L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH, 45267, USA.
University of Cincinnati Medical Center · USKing Saud University · SAQassim University · SA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Anti-Obesity AgentsDrug-Related Side Effects and Adverse ReactionsAdultAdverse Drug Reaction Reporting SystemsDatabases, FactualFemaleHumansMiddle AgedObesityRetrospective StudiesUnited StatesUnited States Food and Drug AdministrationAnti-Obesity AgentsAdverse eventsAdverse reactionsAnti-obesity medicationsCardiovascular diseaseDrug safetyDrug utilizationFDA Adverse Events Reporting SystemObesity

Identifiers

PMID34564826
OpenAlexW3175042504

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.