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Epidemiology and Population Health

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

International Journal of Obesity volume 44, pages 1021–1027 (2020)Cite this article

Subjects

Abstract

Aims

Over the past several decades, many antiobesity drugs have been withdrawn from the market due to unanticipated adverse events, often involving cardiotoxicity.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.

Methods

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).

Results

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 drugs were associated with a safety signal for valvulopathy, PH, or other cardiovascular events.

Conclusions

Our analyses revealed a signal for valvular disorders with lorcaserin and did not detect a safety signal for other cardiovascular events with recently approved antiobesity drugs. Further research is needed to explore and validate this signal.

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Fig. 1: Forest plot of ROR of valvulopathy with the use of lorcaserin and phentermine/–topiramate.
Fig. 2: Forest plot of ROR of PH with the use of lorcaserin and phentermine/–topiramate.
Fig. 3: Forest plot of ROR of CV ADEs with the use of lorcaserin, phentermine/–topiramate and naltrexone–bupropion.
Fig. 4: ROR and 95% CI over the time of valvulopathy in lorcaserin cases versus all other drugs in the FAERS between January 2013 and December 2018.

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Authors and Affiliations

  1. Division of Clinical Pharmacy, Faculty of Medicine, School of Pharmacy, The Institute for Drug Research, The Hebrew University of Jerusalem, Jerusalem, Israel

    Einat Gorelik, Reem Masarwa, Amichai Perlman, Bruria Hirsh-Raccah & Ilan Matok

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  1. Einat Gorelik
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Correspondence to Ilan Matok.

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Gorelik, E., Gorelik, B., Masarwa, R. et al. The cardiovascular safety of antiobesity drugs—analysis of signals in the FDA Adverse Event Report System Database. Int J Obes 44, 1021–1027 (2020). https://doi.org/10.1038/s41366-020-0544-4

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