Date of Award

Spring 5-2023

Document Type

Thesis

Degree Name

Master of Science (MS)

Department

Pharmaceutical Sciences

First Advisor

Enrique Seoane-Vazquez

Second Advisor

Rosa Rodriguez-Monguio

Third Advisor

Lawrence M. Brown

Fourth Advisor

Marc L. Fleming

Abstract

INTRODUCTION: The use of drugs can lead to renal adverse effects prompting the need to include warnings and precautions on medication labels. Studies evaluating renal warnings and precautions need to be improved. This study assessed the characteristics of FDA renal toxicity warnings and precautions included in the labels of drugs approved by the FDA and marked in the US. The study also evaluated the potential factors of including a boxed warning on a drug label.

METHODS: We extracted the labels of human prescription drugs with renal toxicity boxed warnings and warnings and precautions from the “FDA Label: Full-Text Search of Drug Product Labeling” database, FDA regulatory information from Drugs@FDA as of September 31, 2022. We extracted the therapeutic classification from the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) Classification System. We conducted descriptive and logistic regression analyses.

RESULTS: The FDA drug label database listed 611 drugs and combinations with renal warnings or boxed warnings for 511 active ingredients as of September 1, 2022. Metformin hydrochloride, hydrochlorothiazide, dextrose, potassium chloride, and amlodipine besylate were the drugs with the highest number of renal warnings and precautions. The greatest number of renal warnings occurred in the 2000-2019 decade. There were 85 drugs, including 3 with emergency use authorization for COVID-19, with a boxed warning mentioning renal toxicity. The largest therapeutic classes with renal toxicity boxed warnings were anti-infectives for systemic use, antineoplastic and immunomodulating agents, and alimentary tract and metabolism. The most common boxed warnings were renal impairment, nephrotoxicity, and nephrogenic systemic fibrosis, with some warnings referring to potential problems for patients with kidney transplants.

CONCLUSIONS: Many FDA-approved drugs have renal warnings and precautions, with preventable adverse drug events being the most common type of warning. Antineoplastic and immunomodulating agents have the highest incidence of renal warnings among therapeutic classes. The FDA approval year and some therapeutic classes are associated with the presence of renal boxed warnings, but other factors may also play a role. Further research is needed to improve drug safety for patients. Patients receiving medication, particularly those receiving drugs associated with renal warnings and precautions, require ongoing monitoring and management.

Creative Commons License

Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

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