FDA Adverse Event Reports on Use of Sibutramine: An Exploratory Analysis

Abstract

Objective:

To report the adverse events associated with sibutramine per the Adverse Event Reporting System (AERS) database.

Methods:

A retrospective database analysis of all domestic and foreign reports of adverse events associated with sibutramine use from September 1997 to March 2002 was conducted. Outcome measures included the total numbers of reports (initial plus follow-up), the mean age of the uniquely identified cases or patients, the number of cases reported as a serious adverse event, the length of therapy prior to serious adverse event, and the mean dose for all outcomes reported.

Results:

There were 4,898 unique reports of adverse events associated with sibutramine use representing 4,749 patients between September 1997 and March 2002 in the AERS database. Of those unique reports, there were 12,081 different adverse events associated with sibutramine use during the 56-month period. The mean ± SD age was 44.39 y ± 12.56 years, while the majority of patients were female (4,153, 87.4%). Uniquely reported outcomes totaled 740 cases, 389 (52.6%) of which were termed serious as a result of the adverse event. Death was listed in 43 (7.8%) reports as the outcome. Twenty-two of those deaths were reported as due to myocardial infarction or cardiac arrest. Many of the adverse event reports were submitted by healthcare professionals (614, 8%), with the majority of reports being periodic (90%). Sibutramine was listed as the primary suspect of the adverse event in 4,433 (83.6%) cases. The average dose of sibutramine was 15 mg, while the median length of therapy was 30 days.

Conclusions:

Although valuable information comes from the AERS database, with so many other variables (risk factors, comorbid conditions, reporting bias, multiple medications) along with the number of persons taking sibutramine (>8 million worldwide), establishing a relationship between sibutramine consumption resulting in various adverse events is difficult. Because of the various limitations of the AERS database, caution must be taken when interpreting the cases reported to the database.