The cardiovascular safety of antiobesity drugs-analysis of signals in the FDA Adverse Event Report System Database.

International Journal of Obesity : Journal of the International Association for the Study of Obesity
Einat GorelikIlan Matok

Abstract

Over the past several decades, many antiobesity drugs have been withdrawn from the market due to unanticipated adverse events, often involving cardiotoxicity. This study aimed to evaluate the presence of cardiovascular safety signals with currently marketed antiobesity drugs. We used the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and retrieved data from January 2013 through December 2018. We performed disproportionality analyses to detect cardiovascular safety signals with three antiobesity drugs recently approved for marketing: lorcaserin, naltrexone-bupropion, phentermine, and phentermine-topiramate. Three main cardiovascular outcomes were evaluated: valvular disorders, and pulmonary hypertension (PH) and other cardiovascular events (myocardial infarction, stroke, cardiovascular death, cardiac failure, and arrhythmia). During the evaluated period, a total of 6,787,840 adverse event reports were submitted to FAERS. Of these, 2687 involved lorcaserin, 3960 involved phentermine/phentermine-topiramate, and 2873 involved naltrexone-bupropion. Lorcaserin was associated with a significantly greater proportion of reports of valvular disorders (ROR = 4.39; 95% CI 2.72-5.07). None of the antiobesity...Continue Reading

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Citations

Jan 19, 2021·Journal of Ethnopharmacology·Seyid Ahmet Sargin
Aug 5, 2021·Current Atherosclerosis Reports·Sean J IwamotoMarc-Andre Cornier

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Software Mentioned

FAERS
pandas
CAMELLIA
statsmodels
orlistat
TIMI

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