FAERS reports involving anti-obesity medications

Abstract

There are numerous serious adverse events associated with anti-obesity medications (AOMs), according to the results of a study analysing cases in the USA’s FDA Adverse Event Reporting System (FAERS), reported in the International Journal of Clinical Pharmacy. The study involved 18 675 reports between January 2013 and June 2020 in 15 143 patients receiving major FDAapproved AOMs. The mean patient age was 49.8 years; 73.4% were female. The most commonly reported adverse event was nausea/vomiting (n=3691), followed by dizziness/headache (n=3540), drug ineffectiveness/weight increase (n=2647), cardiovascular disorders (n=1765) and acute kidney failure/kidney injury (n=1327). There were 1039 deaths (4.9%); other serious events resulted in life-threatening events (7.6%), hospitalisation (35%) or disability (5.9%). The incidence of cardiovascular disorders was higher in patients who received phentermine (31%), liraglutide (23%) or phentermine/topiramate (22%) compared with orlistat (10%) or locarserin (8%). The incidence of acute kidney failure/kidney injury was also relatively high (38%, 23% and 17%, respectively), as was the incidence of fatal or lifethreatening outcomes (12%, 14% and 15%). Since we did not limit our analysis to the only primary suspected medications , note the authors, the values only provide safety signals and do not denote a real risk . They add that it is essential to continue and systematically observe AOM’s safety to optimize their use .