Drug Injury Watch

Vascular Endothelial Growth Factor (VEGF) Inhibitors: Increased Risk Of Aneurysm And Artery Dissection

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.

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Here in the US , meanwhile, 16 brand name VEGF 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 VEGF 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 VEGF 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 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.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Beovu Retinal Vasculitis Case Report Is Presented In August 2020 Medical Journal Article

Woman Developed Acute And Severe Loss Of Visual Acuity Following Her Second Beovu Injection

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Beovu (brolucizumab) was approved by the FDA in 2019 for the treatment of neovascular (wet) age-related macular degeneration (AMD).  Since then there have been reports of Beovu-associated vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.  For example, we point out a Beovu retinal vasculitis case report that was presented by means of a recent medical journal article.

From the Abstract for this JAMA Ophthalmology medical journal article, "Retinal Vasculitis After Administration of Brolucizumab Resulting in Severe Loss of Visual Acuity" (published online August 6, 2020), we get the following five facts concerning a Beovu retinal vasculitis case report:

1. A 77-year-old woman had acute visual acuity loss in her right eye following her second administration of [Beovu (brolucizumab)] for neovascular age-related macular degeneration.
2. She had previously been treated with both [Avastin (bevacizumab)] and [Eylea (aflibercept)] since her initial diagnosis in 2018. She had never had any intraocular inflammation with either medication.
3. Her baseline visual acuity was 20/50 OD and 20/30 OS.
4. She initially noted blurry vision immediately after her injection with [Beovu (brolucizumab)] but believed it would be temporary. She presented to the office 3 weeks later, on her return from a cruise. Her visual acuity was 20/200 OU.
5. Her left eye was unremarkable.

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If you want to learn more about the vision-related safety issues associated with Beovu injections, you may want to review one or more of our earlier Drug Injury Watch articles about Beovu:

• Possible Beovu Side Effects Discussed At American Society of Retina Specialists Annual Meeting In July 2020 (July 28, 2020)
• Beovu Safety Signal Found By External Review Committee Which Evaluated Beovu Post-Marketing Adverse Events (July 1, 2020)
• Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020 (June 17, 2020)
• Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report (April 9, 2020)
• Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings (March 4, 2020)
• Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug (February 27, 2020)

We will continue to monitor the medical literature for reports of retinal vasculitis with Beovu use as well as cases of acute visual acuity loss involving Beovu.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)