New Warnings Added To Drug Labels For All VEGF Inhibitors By UK’s MHRA Already; FDA Is Evaluating Need For Regulatory Action

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

On July 31, 2020 the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued this Drug Safety Update, “Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection“, which began as follows:

Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients with risk factors. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as hypertension.

This July 2020 MHRA Drug Safety Update presented these two points in the “Update for healthcare professionals” section:

  • use of systemically administered VEGF pathway inhibitors (see list in background) in patients with or without hypertension may promote the formation of aneurysms or artery dissections
  • aneurysms or artery dissections are thought to occur infrequently in patients taking systemic VEGF pathway inhibitors, but some fatal cases have been reported, mainly in relation to aortic aneurysm rupture and aortic dissection

From the “European review of cases of aneurysm and artery dissection” part of that MHRA document we get these details:

A recent European review concluded that all systemically administered VEGF pathway inhibitors may promote the formation of aneurysm and artery dissection. The product information for all systemically administered VEGF pathway inhibitors has been updated to include a warning about the risk of aneurysm and artery dissection and to recommend carefully considering these risks before initiating in patients with risk factors, such as hypertension.

Here in the US , meanwhile, 16 brand name VGEF inhibitors appeared on the “January – March 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)“, which is sometimes called the FDA Watch List.

These are the VGEF inhibitors identified in this most recent FDA Watch List:

Inlyta (axitinib)
Avastin (bevacizumab)
Cabometyx (cabozantinib)
Caprelsa (vandetanib)
Cometriq (cabozantinib)
Cyramza (ramucirumab)
Iclusig (ponatinib)
Lenvima (lenvatinib)
Mvasi (bevacizumab-awwb)
Nexavar (sorafenib tosylate)
Ofev (nintedanib)
Stivarga (regorafenib)
Sutent (sunitinib malate)
Votrient (pazopanib)
Zaltrap (ziv-aflibercept)
Zirabev (bevacizumab-bvzr)

As regards those VGEF inhibitors, the FDA Watch List document states:

  • Potential Signal of a Serious Risk / New Safety Information — Aneurysm and artery dissection
  • Additional Information (as of June 12, 2020) — FDA is evaluating the need for regulatory action.

We will continue to monitor the safety profiles for these VGEF 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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