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Clinical Studies and Practice

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

International Journal of Obesity volume 40, pages 1742–1747 (2016)Cite this article

Subjects

Abstract

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 Although several products have been withdrawn from the market and new medicines are being marketed, the utilisation of antiobesity medicines is widespread, and therefore systematic monitoring of the safety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.

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Acknowledgements

We thank the European Medicines Agency for providing access to data (EMA/712166/2014).

Author contributions

EHH, LA, CEH conceived and designed the study; CEH, LA and EHH performed the experiments and LA, CEH and EHH analysed the data and wrote the final paper.

Author information

Authors and Affiliations

  1. Department of Public Health, Clinical Pharmacology and Pharmacy, Faculty of Health Sciences, University of Southern Denmark, Odense C, Denmark

    L Aagaard

  2. Danish Pharmacovigilance Research Project (DANPREP), University of Copenhagen, Copenhagen, Denmark

    L Aagaard & E H Hansen

  3. Department of Pharmacy, CORS, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

    C E Hallgreen

  4. Department of Pharmacy, Social and Clinical Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

    E H Hansen

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  1. L Aagaard
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Corresponding author

Correspondence to L Aagaard.

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The authors declare no conflict of interest.

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Aagaard, L., Hallgreen, C. & Hansen, E. Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance. Int J Obes 40, 1742–1747 (2016). https://doi.org/10.1038/ijo.2016.135

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