Safety profile and adverse drug reaction with causality assessment of Dapagliflozin in diabetes

  • Prabhudatta Mohapatra Sri Jayadev College of Pharmaceutical Sciences, Naharkanta, Bhubaneswar, India-752101
  • Karmajeet Rath IMS & SUM HOSPITAL, Siksha ‘O’ Anusandhan, Bhubaneswar, India-751003
  • Priyabrata Pattanayak Sri Jayadev College of Pharmaceutical Sciences, Naharkanta, Bhubaneswar, India-752101
Keywords: Dapagliflozin, polychondritis, adverse drug reaction, patient safety profile

Abstract

Introduction: Diabetes mellitus is a metabolic disorder characterized by high blood sugar levels and may damage nerves, kidneys, and other organs in the body. Currently, there are different anti-diabetic drugs prescribed by the physician to treat diabetes mellitus. Among them, dapagliflozin is now commonly prescribed for reducing blood glucose levels along with kidney protection.

Objective: The primary objective of the study was to describe adverse drug reaction (ADR) of dapagliflozin.

Methods: This is a clinical observational study of an 81-year-old male patient with a hyperglycemic condition. Here the patient case study was done for the safety purpose in diabetes mellitus.

Result: In this case of dapagliflozin intake the patient suffered from itching and rashes with redness in the bilateral external earlobes. The dermatologist labeled it as polychondritis of the ear cartilage. Recurrence of the symptoms when the patient was rechallenged with dapagliflozin. As per the dechallenge and rechallenge done in the patient, the withdrawal of dapagliflozin freed up this particular side effect.

Conclusion: The patient was detected with an adverse drug reaction due to the intake of dapagliflozin. So, any administration of dapagliflozin should be followed up with possible polychondritis or itching and rashes in the skin in general and the ear lobe in particular.

Author Biography

Prabhudatta Mohapatra, Sri Jayadev College of Pharmaceutical Sciences, Naharkanta, Bhubaneswar, India-752101

Asst. Professor

References

Anderson S. L. (2014). Dapagliflozin efficacy and safety: a perspective review. Therapeutic advances in drug safety, 5(6), 242–254.

Danaei, G., Finucane, M. M., Lu, Y., Singh, G. M., Cowan, M. J., Paciorek, C. J., Lin, J. K., Farzadfar, F., Khang, Y. H., Stevens, G. A., Rao, M., Ali, M. K., Riley, L. M., Robinson, C. A., Ezzati, M., & Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Glucose) (2011). National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2·7 million participants. Lancet (London, England), 378(9785), 31–40.

Fioretto, P., Giaccari, A., & Sesti, G. (2015). Efficacy and safety of dapagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in diabetes mellitus. Cardiovascular diabetology, 14, 142.

Heerspink, H., Stefansson, B. V., Correa-Rotter, R., Chertow, G. M., Greene, T., Hou, F. F., Mann, J.,McMurray, J., Lindberg, M., Rossing, P., Sjostrom, C. D.,Toto, R. D., Langkilde, A. M., Wheeler, D. C., & DAPACKD Trial Committees and Investigators (2020).Dapagliflozin in Patients with Chronic Kidney Disease. The New England journal of medicine, 383(15), 1436–1446.

List, J. F., Woo, V., Morales, E., Tang, W., & Fiedorek, F. T. (2009). Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Diabetes care, 32(4), 650–657.

Op den Kamp, Y., de Ligt, M., Dautzenberg, B., Kornips, E., Esterline, R., Hesselink, M., Hoeks, J., Schrauwen-Hinderling, V. B., Havekes, B., Oscarsson, J., Phielix, E., & Schrauwen, P. (2021). Effects of the SGLT2 Inhibitor Dapagliflozin on Energy Metabolism in Patients With Type 2 Diabetes: A Randomized, Double-Blind Crossover Trial. Diabetes care, 44(6), 1334–1343.

Ptaszynska, A., Cohen, S. M., Messing, E. M., Reilly, T. P., Johnsson, E., & Johnsson, K. (2015). Assessing Bladder Cancer Risk in Type 2 Diabetes Clinical Trials: the Dapagliflozin Drug Development Program as a 'Case Study'. Diabetes therapy: research, treatment and education of diabetes and related disorders, 6(3), 357–375.

Singh, M., Sharma, R., Kumar, A. (2019). Safety of SGLT2 Inhibitors in Patients with Diabetes Mellitus. Current Drug Safety, 14(2), 87-93.

Published
2022-06-01
How to Cite
1.
Mohapatra P, Rath K, Pattanayak P. Safety profile and adverse drug reaction with causality assessment of Dapagliflozin in diabetes . jpadr [Internet]. 2022Jun.1 [cited 2022Jul.4];3(2):38-0. Available from: https://jpadr.com/index.php/jpadr/article/view/68