Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance

• Published in: International Journal of Obesity 2016-11, Vol.40 (11), p.1742-1747
• Main Authors: Aagaard, L, Hallgreen, C E, Hansen, E H
• Format: Article
• Language: English
• Subjects: 692/499; 692/700/478/174; Adolescent; Adult; Adverse and side effects; Adverse Drug Reaction Reporting Systems; Adverse events; Age; Analysis; Anti-Obesity Agents - adverse effects; Cardiovascular Diseases - chemically induced; Cardiovascular Diseases - epidemiology; Child; Community Participation; Complications and side effects; Congenital diseases; Consumers; Databases, Factual; Denmark - epidemiology; Disorders; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drugs; Epidemiology; Female; Health aspects; Health Promotion and Disease Prevention; Health sciences; Heart; Humans; Internal Medicine; Male; Marketing; Medicine; Medicine & Public Health; Mental disorders; Metabolic Diseases; Middle Aged; Obesity - drug therapy; original-article; Pharmacovigilance; Psychoses, Substance-Induced - epidemiology; Public Health; Retrospective Studies; Sex; Weight reducing preparations; Young Adult
• ISSN: 0307-0565; 1476-5497
• DOI: 10.1038/ijo.2016.135

Background: Use of antiobesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after the time of marketing. In Europe, information about AEs reported for antiobesity medicines can be accessed in the EudraVigilance (EV) database. Therefore, we aimed to identify and characterise AEs associated with the use of antiobesity medicines in Europe. Methods: AE reports submitted for antiobesity medicines (Anatomical Therapeutic Chemical (ATC) group A08A) from 2007 to 2014 and located in the EV database were analysed. AE data were categorised with respect to time, age and sex of patient/consumer, type of reporter, category and seriousness of reported AEs and medicines. Consumer AE reports were compared with reports from other types of reporters with respect to age and sex of consumer, seriousness, system organ class and medicine. The unit of analysis was one AE and one AE report, respectively. Results: We located 4941 AE reports corresponding to 13 957 AEs for antiobesity medicines in the EV database. More than 90% of all AE cases were serious, including 159 deaths. The majority of AE cases were reported for female adults. The majority of serious AEs was reported for orlistat (37%) and rimonabant (22%). The largest share of serious AEs was of the type 'cardiac disorders’ (19%) and ‘psychiatric disorders’ (18%). Consumer AEs reporting differed from other sources with respect to share and seriousness of AEs, type of AEs (system organ class) and medicines (ATC level 5). Conclusions: Many serious AEs were found for antiobesity medicines in EV, and consumers contributed with a relatively high share of reports. Although several products have been withdrawn from the market and new medicines are being marketed, the utilisation of antiobesity medicines is widespread, and therefore systematic monitoring of the safety of these medicines is necessary.