Skip to main content

Advertisement

SpringerLink
Log in

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013–2020

  • Research Article
  • Published:
International Journal of Clinical Pharmacy Aims and scope Submit manuscript

Abstract


Background Obesity is a globally growing health problem, and its treatment has been challenging. The use of anti-obesity medications (AOMs) has been associated with severe adverse events (AEs). Several AOMs have been withdrawn from the market owing to documented AEs. Aim To describe, estimate and characterize the frequency of AEs attributable to the use of the AOMs, and investigate previously unreported potential AEs associated with AOMs. Method Using the US FDA Adverse Event Reporting System (FAERS) between January 2013 and June 2020, a retrospective, descriptive analysis was conducted to analyze all major reported AEs and outcomes including death, life-threatening, hospitalization, disability, and required intervention or congenital anomaly. The total numbers of AEs reports, cases, adverse reactions and outcomes were calculated for each medication. Results 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 most frequently reported AEs were nausea and vomiting, followed by dizziness and headache, drug ineffectiveness, cardiovascular diseases, and kidney complications. There were 21,229 unique outcomes, including 1039 deaths (fatality ratio of 4.9% of all analyzed reports), 1613 (7.6%) life-threatening events, 7426 (35%) hospitalizations, and 1249 (5.9%) disability cases. Phentermine/topiramate fatal cases represent 6% of the overall medication's reported AEs. Cardiovascular AEs represented 31%, 23%, and 22% of phentermine, liraglutide, and phentermine/topiramate total AEs, respectively. Conclusion The analysis of FAERS database revealed numerous serious AEs associated with AOMs. These AEs can lead to serious cardiovascular and kidney complications. It is necessary to continue and systematically monitor safety of AOMs’ to optimize patient anti-obesity therapy.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. GHO | By category | Overweight / Obesity [Internet]. [cited 2021]. Available from: https://apps.who.int/gho/data/node.main.A896?lang=en.

  2. Products - Data Briefs - Number 360 - February 2020 [Internet]. [cited 2020]. Available from: https://www.cdc.gov/nchs/products/databriefs/db360.htm.

  3. The State of Obesity 2020: Better Policies for a Healthier America - tfah [Internet]. [cited 2020]. Available from: https://www.tfah.org/report-details/state-of-obesity-2020/.

  4. Field AE, Coakley EH, Must A, Spadano JL, Laird N, Dietz WH, et al. Impact of overweight on the risk of developing common chronic diseases during a 10-year period. Arch Intern Med. 2001;161:1581–6.

    Article  CAS  PubMed  Google Scholar 

  5. Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor F, Bales VS, et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003;289:76–9.

    Article  PubMed  Google Scholar 

  6. Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999;282:1523–9.

    Article  CAS  PubMed  Google Scholar 

  7. Cairney J, Wade TJ. Correlates of body weight in the 1994 National Population Health Survey. Int J Obes Relat Metab Disord. 1998;22:584–91.

    Article  CAS  PubMed  Google Scholar 

  8. Williams EP, Mesidor M, Winters K, Dubbert PM, Wyatt SB. Overweight and obesity: prevalence, consequences, and causes of a growing public health problem. Curr Obes Rep. 2015;4:363–70.

    Article  PubMed  Google Scholar 

  9. Patterson RE, Frank LL, Kristal AR, White E. A comprehensive examination of health conditions associated with obesity in older adults. Am J Prev Med. 2004;27:385–90.

    Article  PubMed  Google Scholar 

  10. Aune D, Sen A, Prasad M, Norat T, Janszky I, Tonstad S, et al. BMI and all cause mortality: systematic review and non-linear dose-response meta-analysis of 230 cohort studies with 37.4 million deaths among 30.3 million participants. BMJ. 2016;353:2156.

    Article  Google Scholar 

  11. Leblanc ES, O’Connor E, Whitlock EP, Patnode CD, Kapka T. Effectiveness of primary care-relevant treatments for obesity in adults: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2011;155:434–47.

    Article  PubMed  Google Scholar 

  12. Sjöström L, Narbro K, Sjöström CD, Karason K, Larsson B, Wedel H, et al. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007;357:741–52.

    Article  PubMed  Google Scholar 

  13. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292(14):1724–37.

    Article  CAS  PubMed  Google Scholar 

  14. Neff KJ, Olbers T, le Roux CW. Bariatric surgery: the challenges with candidate selection, individualizing treatment and clinical outcomes. BMC Med. 2013;11:8.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. Who is a Candidate for Bariatric Surgery? | Patients | ASMBS [Internet]. [cited 2020]. Available from: https://asmbs.org/patients/who-is-a-candidate-for-bariatric-surgery.

  16. Sargent BJ, Moore NA. New central targets for the treatment of obesity. Br J Clin Pharmacol. 2009;68:852–60.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  17. Elangovan A, Shah R, Smith ZL. Pharmacotherapy for obesity—trends using a population level national database. Obes Surg. 2021;31(3):1105–12.

    Article  PubMed  Google Scholar 

  18. Rodgers RJ, Tschöp MH, Wilding JPH. Anti-obesity drugs: past, present and future. Dis Model Mech. 2012;5:621–6.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  19. Connolly HM, Crary JL, McGoon MD, Hensrud DD, Edwards BS, Edwards WD, et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997;337:581–8.

    Article  CAS  PubMed  Google Scholar 

  20. James WPT, Caterson ID, Coutinho W, Finer N, Van Gaal LF, Maggioni AP, et al. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med. 2010;363:905–17.

    Article  CAS  PubMed  Google Scholar 

  21. Abbott Withdraws Sibutramine From Market [Internet]. [cited 2020]. Available from: https://www.medscape.com/viewarticle/730155.

  22. Lorcaserin (Belviq) Withdrawn From US Market Due to Cancer Risk [Internet]. [cited 2020]. Available from: https://www.medscape.com/viewarticle/925253.

  23. Derosa G, Maffioli P. Anti-obesity drugs: a review about their effects and their safety. Expert Opin Drug Saf. 2012;11(3):459–71.

    Article  CAS  PubMed  Google Scholar 

  24. Patel DK, Stanford FC. Safety and tolerability of new-generation anti-obesity medications: a narrative review. Postgrad Med. 2018;130:173–82.

    Article  PubMed  PubMed Central  Google Scholar 

  25. Srivastava G, Apovian C. Future pharmacotherapy for obesity: new anti-obesity drugs on the horizon. Curr Obes Rep. 2018;7:147–61.

    Article  PubMed  Google Scholar 

  26. Aagaard L, Hansen EH. Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics SSRIs and NSAIDs. BMC Clin Pharmacol. 2009;9:4.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  27. Hatahira H, Abe J, Hane Y, Matsui T, Sasaoka S, Motooka Y, et al. Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases. J Pharm Health Care Sci. 2017;3:19.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Kato Y, Umetsu R, Abe J, Ueda N, Nakayama Y, Kinosada Y, et al. Hyperglycemic adverse events following antipsychotic drug administration in spontaneous adverse event reports. J Pharm Health Care Sci. 2015;1:15.

    Article  PubMed  PubMed Central  Google Scholar 

  29. Questions and Answers on FDA’s Adverse Event Reporting System (FAERS) | FDA [Internet]. [cited 2021]. Available from: https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers.

  30. Drugs@FDA: FDA-Approved Drugs [Internet]. [cited 2020]. Available from: https://www.accessdata.fda.gov/scripts/cder/daf/.

  31. Lindquist M, Ståhl M, Bate A, Edwards IR, Meyboom RH. A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database. Drug Saf. 2000;23:533–42.

    Article  CAS  PubMed  Google Scholar 

  32. Aagaard L, Hallgreen CE, Hansen EH. Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance. Int J Obes. 2016;40:1742–7.

    Article  CAS  Google Scholar 

  33. Aagaard L, Strandell J, Melskens L, Petersen PS, Hansen EH. Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBaseTM. Drug Saf. 2012;35:1171–82.

    Article  PubMed  Google Scholar 

  34. Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969–2002: the importance of reporting suspected reactions. Arch Intern Med. 2005;165:1363–9.

    Article  PubMed  Google Scholar 

  35. Khera R, Murad MH, Chandar AK, Dulai PS, Wang Z, Prokop LJ, et al. Association of pharmacological treatments for obesity with weight loss and adverse events: a systematic review and meta-analysis. JAMA. 2016;315:2424–34.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  36. Kose M, Emet S, Akpinar TS, Ilhan M, Gok AF, Dadashov M, et al. An unexpected result of obesity treatment: orlistat-related acute pancreatitis. Case Rep Gastroenterol. 2015;9:152–5.

    Article  PubMed  PubMed Central  Google Scholar 

  37. Johansson K, Neovius K, DeSantis SM, Rössner S, Neovius M. Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis. Obes Rev. 2009;10:564–75.

    Article  CAS  PubMed  Google Scholar 

  38. Sjöström L, Rissanen A, Andersen T, Boldrin M, Golay A, Koppeschaar HP, et al. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. Lancet. 1998;352:167–72.

    Article  PubMed  Google Scholar 

  39. Finer N, James WP, Kopelman PG, Lean ME, Williams G. One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor. Int J Obes Relat Metab Disord. 2000;24:306–13.

    Article  CAS  PubMed  Google Scholar 

  40. Medications Target Long-Term Weight Control | FDA [Internet]. [cited 2021]. Available from: https://www.fda.gov/consumers/consumer-updates/medications-target-long-term-weight-control.

  41. Srivastava G, Apovian CM. Current pharmacotherapy for obesity. Nat Rev Endocrinol. 2018;14:12–24.

    Article  CAS  PubMed  Google Scholar 

  42. Hampp C, Kang EM, Borders-Hemphill V. Use of prescription antiobesity drugs in the United States. Pharmacotherapy. 2013;33:1299–307.

    Article  PubMed  PubMed Central  Google Scholar 

  43. Gadde KM, Allison DB, Ryan DH, Peterson CA, Troupin B, Schwiers ML, et al. Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377:1341–52.

    Article  CAS  PubMed  Google Scholar 

  44. Allison DB, Gadde KM, Garvey WT, Peterson CA, Schwiers ML, Najarian T, et al. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP). Obesity (Silver Spring). 2012;20:330–42.

    Article  CAS  Google Scholar 

  45. Velazquez A, Apovian CM. Updates on obesity pharmacotherapy. Ann N Y Acad Sci. 2018;1411:106–19.

    Article  PubMed  Google Scholar 

  46. Tak YJ, Lee SY. Anti-obesity drugs: long-term efficacy and safety: an updated review. World J Men’s Health. 2021;39(2):208.

    Article  Google Scholar 

  47. Daneschvar HL, Aronson MD, Smetana GW. FDA-approved anti-obesity drugs in the United States. Am J Med. 2016;129(879):e1-6.

    Google Scholar 

  48. Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA. 2014;311:74–86.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  49. Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, et al. Cardiovascular safety of lorcaserin in overweight or obese patients. N Engl J Med. 2018;379:1107–17.

    Article  CAS  PubMed  Google Scholar 

  50. Kumar R, Ryan D. Lorcaserin departs, leaving more questions than answers. Obesity (Silver Spring). 2020;28:1167–1167.

    Article  Google Scholar 

  51. Teng C, Walter EA, Gaspar DKS, Obodozie-Ofoegbu OO, Frei CR. Torsades de pointes and QT prolongation associations with antibiotics: a pharmacovigilance study of the FDA Adverse Event Reporting System. Int J Med Sci. 2019;16:1018–22.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  52. Liraglutide Injection: MedlinePlus Drug Information [Internet]. [cited 2021 ]. Available from: https://medlineplus.gov/druginfo/meds/a611003.html.

  53. U.S. GAO - Obesity Drugs: Few Adults Used Prescription Drugs for Weight Loss and Insurance Coverage Varied [Internet]. [cited 2021]. Available from: https://www.gao.gov/products/GAO-19-577.

Download references

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Author information

Authors and Affiliations

  1. James L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH, 45267, USA

    Abdulrahman Alsuhibani, Marwan Alrasheed, Musaab Gari, Ana L. Hincapie & Jeff Jianfei Guo

  2. Department of Pharmacy Practice, Unaizah College of Pharmacy, Qassim University, Unaizah, Saudi Arabia

    Abdulrahman Alsuhibani

  3. Department of Clinical Pharmacy, King Saud University College of Pharmacy, Riyadh, Saudi Arabia

    Marwan Alrasheed

Authors
  1. Abdulrahman Alsuhibani
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Marwan Alrasheed
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Musaab Gari
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Ana L. Hincapie
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Jeff Jianfei Guo
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Abdulrahman Alsuhibani.

Ethics declarations

Conflicts of interest

The authors have no commercial associations that might be a conflict of interest concerning this article.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Alsuhibani, A., Alrasheed, M., Gari, M. et al. Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013–2020. Int J Clin Pharm 44, 172–179 (2022). https://doi.org/10.1007/s11096-021-01330-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11096-021-01330-2

Keywords

Search

Navigation