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Wound healing complications with lenvatinib identified in a pharmacovigilance database.

Authors
  • Cheng, Connie1
  • Nayernama, Afrouz1
  • Christopher Jones, S1
  • Casey, Denise2
  • Waldron, Peter E1
  • 1 Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • 2 Division of Oncology Products, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Type
Published Article
Journal
Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners
Publication Date
Dec 01, 2019
Volume
25
Issue
8
Pages
1817–1822
Identifiers
DOI: 10.1177/1078155218817109
PMID: 30501381
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

The U.S. Food and Drug Administration (FDA) has approved several vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors, including lenvatinib, for thyroid and renal malignancies. Inhibition of the VEGFR signaling pathway impairs angiogenesis and can disrupt wound healing. The objective of this work was to evaluate wound healing complications as a potential safety risk for patients treated with lenvatinib. We searched the FDA Adverse Event Reporting System (FAERS) database for postmarketing reports of wound healing complications with lenvatinib between 13 February 2015 (FDA approval date) and 15 February 2017. The search identified nine FAERS cases of lenvatinib-associated wound healing complications that were not previously reported in the medical literature. Seven cases involved postoperative wound healing complications, such as impaired healing or wound dehiscence. In our case series, the reported time to identification of delayed wound healing from tissue injury or surgery varied over a wide range (4-58 days). The time of initial lenvatinib exposure relative to the tissue injury was also highly varied in our series, which may have influenced the development and detection of impaired healing. FAERS case-level evidence suggests that lenvatinib may have contributed to wound healing complications based on temporality and biologic plausibility. Healthcare professionals should be aware of this safety risk to facilitate prompt recognition and risk mitigation.

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