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

Int J Obes (Lond). 2020 May;44(5):1021-1027. doi: 10.1038/s41366-020-0544-4. Epub 2020 Mar 9.


Aims: Over the past several decades, many antiobesity drugs have been withdrawn from the market due to unanticipated adverse events, often involving cardiotoxicity.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

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Aged
  • Anti-Obesity Agents / adverse effects*
  • Anti-Obesity Agents / therapeutic use
  • Benzazepines / adverse effects
  • Benzazepines / therapeutic use
  • Cardiovascular Diseases* / chemically induced
  • Cardiovascular Diseases* / epidemiology
  • Databases, Factual
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Naltrexone / adverse effects
  • Naltrexone / therapeutic use
  • Obesity / drug therapy
  • Phentermine / adverse effects
  • Phentermine / therapeutic use
  • United States
  • United States Food and Drug Administration


  • Anti-Obesity Agents
  • Benzazepines
  • Naltrexone
  • lorcaserin
  • Phentermine