Retrospective pharmacovigilance analysis of nonsteroidal anti-inflammatory drugs-induced chronic kidney disease

BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with kidney damage. In India, only a few reports related to the risk of chronic kidney disease (CKD) with NSAIDs are available. The present study highlights the prevalence and pattern of NSAIDs-induced CKD adverse drug reactions in the Indian population. MATERIALS AND METHODS: The individual case safety reports (ICSRs) reported by the National Coordination Centre (NCC)-Pharmacovigilance Program of India to the Uppsala monitoring center Pharmacovigilance database system VigiLyze were analyzed by using the preferred term Chronic Kidney Disease and NSAIDs from July 1, 2011 to September 12, 2019. A total of 28 ICSRs of NSAIDs associated CKD ICSRs were analyzed retrospectively for age, gender, concomitant medication, seriousness, and other criteria. RESULTS: About 82% of CKD cases due to NSAIDs were in the age group of 40-80 years, in which 54% belong to male. About 43% of the patients had CKD due to the use of diclofenac, and almost 96% of the patients had oral dosage forms of NSAIDs. The main indications of NSAIDs in these CKD cases were generalized body pain and joint pain. About 79% case of NSAID-induced CKD were serious, among which 54% led to the hospitalization and further use of NSAIDs discontinued in 86% of CKD cases. CONCLUSION: The present study revealed that prolonged use of NSAIDs in chronic pain conditions was responsible for CKD. To reduce the risk of NSAIDs-induced CKD, health care professionals should take the necessary steps to improve patient safety.

Automated summary

The study in India found that the age group of 40-80 years is at high risk for NSAIDs-induced CKD, with a majority being male and most cases caused by diclofenac. About 79% of the cases were serious, requiring hospitalization for further treatment, and NSAIDs were discontinued in 86% of the cases.