Descriptive Analysis of Reported Adverse Events Associated with Antiobesity Medications Using FDA Adverse Event Reporting System (FAERS) Databases 2013-2020

Background Obesity is a globally growing health problem, and its treatment has been challenging. The usage of antiobesity medications (AOMs) has been associated with severe adverse events (AEs). Spontaneous reports of AOMs can present detailed information about AEs occurring after the time of marketing. Several AOMs have been withdrawn from the market owing to documented AEs. Objective To estimate and characterize the frequency of AEs attributable to the use of the AOMs between January 2013 and June 2020. Setting: US FDA Adverse Event Reporting System (FAERS) between January 01, 2013, and June 31, 2020, Methods A retrospective, descriptive analysis was conducted to analyze all major reported AEs including death, life-threatening, hospitalization, disability, and required intervention or congenital anomaly related to AOMs. The total numbers of AEs reports, cases, adverse reactions and outcomes were calculated for each medication, and patients' mean age and gender were reported. Results We found a total of 18,675 unique AEs reports associated with AOMs used for 15,143 patients. The mean age was 49.8 years [SD 1.83], while most patients were female adults (73.4 %). The main AEs of the safety reports were nausea, headache, cardiovascular diseases, dizziness, drug ineffectiveness, acute kidney failure/ kidney injury, and dry mouth. The FAERS database had 21,229 unique outcomes involving AOMs use, including 1,039 deaths (fatality ratio of 4.9% of all analyzed reports), 1,613 (7.6%) life-threatening events, 7,426 (35%) hospitalizations, and 1,249 (5.9%) disability cases. Phentermine/topiramate fatal cases represent 6% of the overall medication's reported AEs. The cardiovascular AEs were 542 reports (31%) for phentermine, 402 reports (23%) for liraglutide, 381 reports (22%) for phentermine/topiramate. Conclusion Although several AOMs have been withdrawn from the market and replaced with new ones, the utilization of the AOMs is widespread; the FAERS database's analysis revealed many serious AEs in the type of cardiovascular diseases and kidney complications attributable to the use of the AOMs. Therefore, it is necessary to continue and systematically monitor AOMs' safety to help optimize their use.