Acute kidney injury and bisphosphonate use in cancer: A report from the research on adverse drug events and reports (RADAR) project

Beatrice J. Edwards*, Sarah Usmani, Dennis W. Raisch, June M McKoy, Athena T. Samaras, Steven M Belknap, Steven M. Trifilio, Allison J Hahr, Andrew D Bunta, Ali Abu-Alfa, Craig Langman, Steve T. Rosen, Dennis P West

*Corresponding author for this work

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Purpose: To determine whether acute kidney injury (AKI) is identified within the US Food and Drug Administration's Adverse Events and Reporting System (FDA AERS) as an adverse event resulting from bisphosphonate (BP) use in cancer therapy. Methods: A search of the FDA AERS records from January 1998 through June 2009 was performed; search terms were "renal problems" and all drug names for BPs. The search resulted in 2,091 reports. We analyzed for signals of disproportional association by calculating the proportional reporting ratio for zoledronic acid (ZOL) and pamidronate. Literature review of BP-associated renal injury within the cancer setting was conducted. Results: Four hundred eighty cases of BP-associated acute kidney injury (AKI) were identified in patients with cancer. Two hundred ninety-eight patients (56%) were female; mean age was 66 ± 10 years. Multiple myeloma (n = 220, 46%), breast cancer (n = 98, 20%), and prostate cancer (n = 24, 5%) were identified. Agents included ZOL (n = 411, 87.5%), pamidronate (n = 8, 17%), and alendronate (n = 36, 2%). Outcomes included hospitalization (n = 304, 63.3%) and death (n = 68, 14%). The proportional reporting ratio for ZOL was 1.22 (95% CI, 1.13 to 1.32) and for pamidronate was 1.55 (95% CI, 1.25 to 1.65), reflecting a nonsignificant safety signal for both drugs. Conclusion: AKI was identified in BP cancer clinical trials, although a safety signal for BPs and AKI within the FDA AERS was not detected. Our findings may be attributed, in part, to clinicians who believe that AKI occurs infrequently; ascribe the AKI to underlying premorbid disease, therapy, or cancer progression; or consider that AKI is a known adverse drug reaction of BPs and thus under-report AKI to the AERS.

Original languageEnglish (US)
Pages (from-to)101-106
Number of pages6
JournalJournal of oncology practice
Volume9
Issue number2
DOIs
StatePublished - Mar 1 2013

Fingerprint

Diphosphonates
Drug-Related Side Effects and Adverse Reactions
Acute Kidney Injury
pamidronate
zoledronic acid
Research
Neoplasms
United States Food and Drug Administration
Kidney
Safety
Alendronate
Multiple Myeloma
Pharmaceutical Preparations
Names
Prostatic Neoplasms
Hospitalization
Clinical Trials
Breast Neoplasms
Food
Wounds and Injuries

ASJC Scopus subject areas

  • Oncology
  • Oncology(nursing)
  • Health Policy

Cite this

Edwards, Beatrice J. ; Usmani, Sarah ; Raisch, Dennis W. ; McKoy, June M ; Samaras, Athena T. ; Belknap, Steven M ; Trifilio, Steven M. ; Hahr, Allison J ; Bunta, Andrew D ; Abu-Alfa, Ali ; Langman, Craig ; Rosen, Steve T. ; West, Dennis P. / Acute kidney injury and bisphosphonate use in cancer : A report from the research on adverse drug events and reports (RADAR) project. In: Journal of oncology practice. 2013 ; Vol. 9, No. 2. pp. 101-106.
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abstract = "Purpose: To determine whether acute kidney injury (AKI) is identified within the US Food and Drug Administration's Adverse Events and Reporting System (FDA AERS) as an adverse event resulting from bisphosphonate (BP) use in cancer therapy. Methods: A search of the FDA AERS records from January 1998 through June 2009 was performed; search terms were {"}renal problems{"} and all drug names for BPs. The search resulted in 2,091 reports. We analyzed for signals of disproportional association by calculating the proportional reporting ratio for zoledronic acid (ZOL) and pamidronate. Literature review of BP-associated renal injury within the cancer setting was conducted. Results: Four hundred eighty cases of BP-associated acute kidney injury (AKI) were identified in patients with cancer. Two hundred ninety-eight patients (56{\%}) were female; mean age was 66 ± 10 years. Multiple myeloma (n = 220, 46{\%}), breast cancer (n = 98, 20{\%}), and prostate cancer (n = 24, 5{\%}) were identified. Agents included ZOL (n = 411, 87.5{\%}), pamidronate (n = 8, 17{\%}), and alendronate (n = 36, 2{\%}). Outcomes included hospitalization (n = 304, 63.3{\%}) and death (n = 68, 14{\%}). The proportional reporting ratio for ZOL was 1.22 (95{\%} CI, 1.13 to 1.32) and for pamidronate was 1.55 (95{\%} CI, 1.25 to 1.65), reflecting a nonsignificant safety signal for both drugs. Conclusion: AKI was identified in BP cancer clinical trials, although a safety signal for BPs and AKI within the FDA AERS was not detected. Our findings may be attributed, in part, to clinicians who believe that AKI occurs infrequently; ascribe the AKI to underlying premorbid disease, therapy, or cancer progression; or consider that AKI is a known adverse drug reaction of BPs and thus under-report AKI to the AERS.",
author = "Edwards, {Beatrice J.} and Sarah Usmani and Raisch, {Dennis W.} and McKoy, {June M} and Samaras, {Athena T.} and Belknap, {Steven M} and Trifilio, {Steven M.} and Hahr, {Allison J} and Bunta, {Andrew D} and Ali Abu-Alfa and Craig Langman and Rosen, {Steve T.} and West, {Dennis P}",
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Acute kidney injury and bisphosphonate use in cancer : A report from the research on adverse drug events and reports (RADAR) project. / Edwards, Beatrice J.; Usmani, Sarah; Raisch, Dennis W.; McKoy, June M; Samaras, Athena T.; Belknap, Steven M; Trifilio, Steven M.; Hahr, Allison J; Bunta, Andrew D; Abu-Alfa, Ali; Langman, Craig; Rosen, Steve T.; West, Dennis P.

In: Journal of oncology practice, Vol. 9, No. 2, 01.03.2013, p. 101-106.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Acute kidney injury and bisphosphonate use in cancer

T2 - A report from the research on adverse drug events and reports (RADAR) project

AU - Edwards, Beatrice J.

AU - Usmani, Sarah

AU - Raisch, Dennis W.

AU - McKoy, June M

AU - Samaras, Athena T.

AU - Belknap, Steven M

AU - Trifilio, Steven M.

AU - Hahr, Allison J

AU - Bunta, Andrew D

AU - Abu-Alfa, Ali

AU - Langman, Craig

AU - Rosen, Steve T.

AU - West, Dennis P

PY - 2013/3/1

Y1 - 2013/3/1

N2 - Purpose: To determine whether acute kidney injury (AKI) is identified within the US Food and Drug Administration's Adverse Events and Reporting System (FDA AERS) as an adverse event resulting from bisphosphonate (BP) use in cancer therapy. Methods: A search of the FDA AERS records from January 1998 through June 2009 was performed; search terms were "renal problems" and all drug names for BPs. The search resulted in 2,091 reports. We analyzed for signals of disproportional association by calculating the proportional reporting ratio for zoledronic acid (ZOL) and pamidronate. Literature review of BP-associated renal injury within the cancer setting was conducted. Results: Four hundred eighty cases of BP-associated acute kidney injury (AKI) were identified in patients with cancer. Two hundred ninety-eight patients (56%) were female; mean age was 66 ± 10 years. Multiple myeloma (n = 220, 46%), breast cancer (n = 98, 20%), and prostate cancer (n = 24, 5%) were identified. Agents included ZOL (n = 411, 87.5%), pamidronate (n = 8, 17%), and alendronate (n = 36, 2%). Outcomes included hospitalization (n = 304, 63.3%) and death (n = 68, 14%). The proportional reporting ratio for ZOL was 1.22 (95% CI, 1.13 to 1.32) and for pamidronate was 1.55 (95% CI, 1.25 to 1.65), reflecting a nonsignificant safety signal for both drugs. Conclusion: AKI was identified in BP cancer clinical trials, although a safety signal for BPs and AKI within the FDA AERS was not detected. Our findings may be attributed, in part, to clinicians who believe that AKI occurs infrequently; ascribe the AKI to underlying premorbid disease, therapy, or cancer progression; or consider that AKI is a known adverse drug reaction of BPs and thus under-report AKI to the AERS.

AB - Purpose: To determine whether acute kidney injury (AKI) is identified within the US Food and Drug Administration's Adverse Events and Reporting System (FDA AERS) as an adverse event resulting from bisphosphonate (BP) use in cancer therapy. Methods: A search of the FDA AERS records from January 1998 through June 2009 was performed; search terms were "renal problems" and all drug names for BPs. The search resulted in 2,091 reports. We analyzed for signals of disproportional association by calculating the proportional reporting ratio for zoledronic acid (ZOL) and pamidronate. Literature review of BP-associated renal injury within the cancer setting was conducted. Results: Four hundred eighty cases of BP-associated acute kidney injury (AKI) were identified in patients with cancer. Two hundred ninety-eight patients (56%) were female; mean age was 66 ± 10 years. Multiple myeloma (n = 220, 46%), breast cancer (n = 98, 20%), and prostate cancer (n = 24, 5%) were identified. Agents included ZOL (n = 411, 87.5%), pamidronate (n = 8, 17%), and alendronate (n = 36, 2%). Outcomes included hospitalization (n = 304, 63.3%) and death (n = 68, 14%). The proportional reporting ratio for ZOL was 1.22 (95% CI, 1.13 to 1.32) and for pamidronate was 1.55 (95% CI, 1.25 to 1.65), reflecting a nonsignificant safety signal for both drugs. Conclusion: AKI was identified in BP cancer clinical trials, although a safety signal for BPs and AKI within the FDA AERS was not detected. Our findings may be attributed, in part, to clinicians who believe that AKI occurs infrequently; ascribe the AKI to underlying premorbid disease, therapy, or cancer progression; or consider that AKI is a known adverse drug reaction of BPs and thus under-report AKI to the AERS.

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