Novel Adverse Events of Bevacizumab in the US FDA Adverse Event Reporting System Database

Shamloo, Behrooz K.; Chhabra, Pankdeep; Freedman, Andrew; Potosky, Arnold L.; Malin, Jennifer L.; Smith, Sheila Weiss

doi:10.2165/11597600-000000000-00000

Cited by 36 publications

(28 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Data from clinical trials demonstrates the association between Bev and several cardiotoxicities; 4,6,28 hence, physicians may carefully prescribe Bev to patients, avoiding those either with a history of or with risk factors for cardiac conditions. This finding is consistent with prior studies using SEER-Medicare data.…”

Section: Discussionmentioning

confidence: 99%

Utilization of bevacizumab in US elderly patients with colorectal cancer receiving chemotherapy

Tsai

Marshall

et al. 2013

J Oncol Pharm Pract

View full text Add to dashboard Cite

Objective Bevacizumab, the first FDA-approved anti-angiogenesis agent, has been used for metastatic colorectal cancer since 2004. This study evaluated the utilization of bevacizumab among elderly metastatic colorectal cancer patients in the United States. Methods Using Surveillance and Epidemiology and End Results (SEER)-Medicare data, this retrospective cohort study consisted of individuals aged 65 years or older with a colorectal cancer diagnosis between 2005 and 2009, who received chemotherapy any time through 2010. This included patients with newly diagnosed metastatic colorectal cancer and patients who progressed from initially diagnosed earlier-stage disease. We ascertained comorbid conditions using ICD-9 codes and conducted logistic regression to identify patients’ characteristics associated with bevacizumab use. Results A total of 8645 patients were identified (mean age 74 years; 52% male); 57% of patients received bevacizumab with initially diagnosed metastatic colorectal cancer and 44% of patients with treated progressive or recurrent disease. After adjusting for other covariates, we found that patients aged ≥80 years were less likely to receive bevacizumab compared with those aged 65–69 years (odds ratio (OR), 0.64 (95% confidence interval (CI): 0.57–0.73)), or if they had evidence of comorbid cardiomyopathy/congestive heart failure (OR, 0.82 (CI: 0.70–0.95)) or arrhythmic disorder (OR, 0.85 (CI: 0.75–0.96)). Adoption of bevacizumab into practice was rapid following its approval, and the use increased from 36% to 40% from 2005 to 2010 (p = 0.013). There were significant regional variations in bevacizumab use. Conclusions Despite rapid uptake since its original approval, there appears to be low use of bevacizumab in elderly metastatic colorectal cancer patients in the United States. Regional variations and the strong effects of age and comorbidity suggest lack of consensus among oncologists regarding benefits and risks of bevacizumab in elderly patients.

show abstract

Section: Discussionmentioning

confidence: 99%

Utilization of bevacizumab in US elderly patients with colorectal cancer receiving chemotherapy

Tsai

Marshall

et al. 2013

J Oncol Pharm Pract

View full text Add to dashboard Cite

show abstract

“…Abscess tissue surrounded the anus and deepened caudally and posteriorly between the buttocks, and there was evidence of gaseous nuclei which were also involved in the anal, perineal and gluteus region, and extended anteriorly to the penile region, a presentation compatible with Fournier's gangrene. bevacizumab, with death resulting in 13.6% of patients (14). A safety alert regarding some cases related to bevacizumab has also been described in literature (15)(16)(17).…”

Section: Discussionmentioning

confidence: 99%

Fournier's gangrene during lenvatinib treatment: A case report

et al. 2020

View full text Add to dashboard Cite

Fournier's gangrene is a rare and severe complication reported in patients with cancer treated with antiangiogenic drugs, most frequently with bevacizumab. The present report describes the case of an 80-year-old man with radioactive iodine-refractory metastatic thyroid cancer treated with lenvatinib (an oral multikinase inhibitor with antiangiogenic properties) who developed Fournier's gangrene in the absence of other known risk factors. To the best of our knowledge, this is the first case described during treatment with lenvatinib. The condition was likely due to a perturbation of vascular endothelial cells of the skin due to the inhibition of VEGF/VEGFR signaling. Fournier's gangrene may be a class effect of antiangiogenic treatment that clinicians should be aware of, as early diagnosis and treatment are associated with an improved outcome.

show abstract

“…Reports may also be accessed by healthcare professionals for further review and evaluation, and in some cases, reports may lead to drug removal from the market or necessary relabeling of serious side effects ( Ahmad, 2003 ;Shamloo et al, 2012 ;Wysowski & Swartz, 2005 ). More than 75 drugs or drug products have been removed from the market between the years 1969 and 2002 because of reports sent to FDA reporting systems ( Wysowski & Swartz, 2005 ).…”

Section: Introductionmentioning

confidence: 99%

Attitudes and Usage of the Food and Drug Administration Adverse Event Reporting System Among Gastroenterology Nurse Practitioners and Physician Assistants

Salk

Ehrenpreis

2016

Gastroenterology Nursing

View full text Add to dashboard Cite

The Food and Drug Administration Adverse Event Reporting System (FAERS) is used for postmarketing pharmacovigilance. Our study sought to assess attitudes and usage of the FAERS among gastroenterology nurse practitioners (NPs) and physician assistants (PAs). A survey was administered at the August 2012 Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant course, held in Chicago, IL. Of the 128 respondents, 123 (96%) reported a specialty in gastroenterology or hepatology and were included in analysis. Eighty-nine participants were NPs and 32 PAs, whereas 2 did not report their profession. Although 119 (98%) agreed or strongly agreed with the statement that accurately reporting adverse drug reactions is an important process to optimize patient safety, the majority of participants (54% NPs and 81% PAs) were unfamiliar with the FAERS. In addition, only 20% of NPs and 9% of PAs reported learning about the FAERS in NP or PA schooling. Our study shows enthusiasm among gastroenterology NPs and PAs for the reporting of adverse drug reactions, coupled with a lack of familiarity with the FAERS. This presents an opportunity for enhanced education about reporting of adverse drug reactions for gastroenterology NPs and PAs.

show abstract

Novel Adverse Events of Bevacizumab in the US FDA Adverse Event Reporting System Database

Cited by 36 publications

References 28 publications

Utilization of bevacizumab in US elderly patients with colorectal cancer receiving chemotherapy

Utilization of bevacizumab in US elderly patients with colorectal cancer receiving chemotherapy

Fournier's gangrene during lenvatinib treatment: A case report

Attitudes and Usage of the Food and Drug Administration Adverse Event Reporting System Among Gastroenterology Nurse Practitioners and Physician Assistants

Contact Info

Product

Resources

About