Soroush Farsi
Background
Alvimopan is a peripherally acting μ-opioid receptor antagonist approved to accelerate gastrointestinal recovery following bowel resection surgery. Concerns regarding cardiovascular safety, including myocardial infarction, have been raised in post-marketing surveillance. This study aimed to characterize adverse events associated with alvimopan using the FDA data base.
Methods
Reports listing alvimopan (Entereg) as a primary suspect drug were extracted from the FDA Adverse Event Monitoring System (AEMS) and analyzed. Demographic characteristics, annual reporting trends, and reported adverse events were evaluated. Adverse events were categorized using Medical Dictionary for Regulatory Activities (MedDRA) preferred terms, and frequencies were calculated.
Results
A total of 233 FAERS reports involving alvimopan were identified, including 215 reports for Entereg and 18 reports for generic formulations. Males accounted for 39.9% of cases (n=93), females 35.6% (n=83), and sex was unspecified in 24.5% (n=57). Most reports involved patients ≥65 years of age (n=73), followed by patients aged 18–64 years (n=63).The most frequently reported adverse events were myocardial infarction (21 cases), abdominal pain (14), nausea (13), acute myocardial infarction (12), and anastomotic leak (11). Other commonly reported events included vomiting, diarrhea, tachycardia, and post-procedural complications. Reporting peaked in 2010 (52 cases) and 2011 (41 cases), with a decline observed after 2016.
Conclusion
Analysis of FAERS reports identified cardiovascular events, particularly myocardial infarction, among the most commonly reported adverse events associated with alvimopan. Gastrointestinal and postoperative complications were also frequently reported. These findings highlight the importance of continued pharmacovigilance when using alvimopan in surgical populations, particularly among older adults.
Authors
Soroush Farsi, Mayo Clinic, Rochester, USA