New Study Shows Further Evidence of Adverse Events in Association With VEGF Inhibitor Drugs
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
A class of cancer treatment drugs labeled as antiangiogenic agents have been associated with artery dissections and aneurysms. An arterial dissection occurs when there is a tear in the lining of an artery, which can cause blood to pool in the area, potentially leading to the formation of a blood clot. An aneurysm is an enlargement of an artery caused by a weakening of the artery wall, and while most aneurysms do not show symptoms, if ruptured they can result in internal bleeding or a stroke.
According to the Medpage Today March 2021 article, "Class of Cancer Drug Linked to Aneurysms, Artery Dissections", which focused on the JAMA Oncology study "Association Between Antiangiogenic Drugs Used for Cancer Treatment and Artery Dissections or Aneurysms", this specific class of cancer drugs are 3 times more likely to result in an artery dissection or aneurysm than other cancer drugs:
The analysis of the WHO's VigiBase database found that artery dissections or aneurysms were nearly three times as likely to be reported with antiangiogenic agents as compared with other cancer drugs (proportional reporting ratio 2.76, 95% CI 2.48-3.07; Bayesian information component 1.14, 95% credibility interval 0.99-1.25), reported Pernelle Noize, PharmD, PhD, of Bordeaux University Hospital in France, and colleagues.
Among nearly 500 cases of artery dissections or aneurysms associated with these agents, 88.3% were serious, with 24.3% being fatal, 17.8% considered life-threatening, and 24.7% leading to or prolonging hospitalization, according to the findings in JAMA Oncology.
The same Medpage Today article lists several vascular endothelial growth factor (VEGF) inhibitors as being associated with artery dissections or aneurysms, including Avastin, Sutent, and Ofev:
Fourteen individual agents in the class were associated with artery dissections or aneurysms, including the VEGF inhibitors bevacizumab (Avastin) and ramucirumab (Cyramza); the tyrosine kinase inhibitors (TKIs) sunitinib (Sutent), pazopanib (Votrient), axitinib (Inlyta), nintedanib (Ofev), and lenvatinib (Lenvima); the multikinase inhibitor cabozantinib (Cometriq, Cabometyx); and the mTOR inhibitor everolimus (Afinitor). A number of these agents were also associated with both aortic- and cerebral-specific events.
VEGF inhibitors were the most commonly involved antiangiogenic agent (51.4%), followed by TKIs (35.8%) and mTOR inhibitors (11.5%). For individual agents, bevacizumab (44.9%), sunitinib (14.4%), and everolimus (11.1%) were most frequently associated with these events. Median time to onset was 89 days (interquartile range 27-212) where data were available.
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The data from this antiangiogenic drug study aligns with the July 2020 Drug Safety Update from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) previously reported on our Drug Injury Watch Blog in August 2020, "Vascular Endothelial Growth Factor (VEGF) Inhibitors: Increased Risk Of Aneurysm And Artery Dissection". The MHRA update required a warning label to be added to all VEGF inhibitors advising of the risks of aneurysm and artery dissection associated with this class of drugs.
This same class of drugs appeared on the January through March 2020 FDA watch list as having a potential signal of serious risk of aneurysm and artery dissection. As of June 2020, the FDA was evaluating the need for regulatory action. This class of drugs did not appear on the following three quarterly reports from the FDA, and whether or not regulatory action will be taken against these drugs is unclear at the present time.
We will continue to monitor the safety profiles for these VEGF inhibitors, including whether the FDA mandates any label changes which add warnings about an increased risk of aneurysm and artery dissection for this class of drugs.
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