Serious adverse events reported for anti-obesity medicines: Post-marketing experiences from the EU adverse event reporting system EudraVigilance.

BACKGROUND: Use of anti-obesity 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 time of marketing. In Europe, information about AEs reported for anti-obesity medicines can be accessed in the EudraVigilance database (EV). Therefore, we aimed to identify and characterise adverse events (AEs) associated with use of anti-obesity medicines in Europe.

METHODS: AE reports submitted for anti-obesity medicines (Anatomical Therapeutic Chemical [ATC] group A08A) from 2007 to 2014 and located in EV 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 (SOC) 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 anti-obesity medicines in EV. 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 AE reporting differed from other sources with respect to share and seriousness of AEs, type of AEs (SOC) and medicines (ATC level 5).

CONCLUSIONS: Many serious AEs were found for anti-obesity 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 Although several products have been withdrawn from the market and new medicines are being marketed, the utilisation of anti-obesity medicines is widespread, and therefore systematic monitoring of the safety of these medicines is necessary.International Journal of Obesity accepted article preview online, 01 August 2016. doi:10.1038/ijo.2016.135.