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, includes an item about all vascular endothelial growth factor inhibitors medicines, i.e., the VEGF inhibitors class of drugs.
As regards those VEGF inhibitors — such as the cancer drugs Avastin (bevacizumab), Iclusig (ponatinib), and Sutent (sunitinib malate), as well as the idiopathic pulmonary fibrosis drug Ofev (nintedanib) — 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.
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 informed as follows about label change for all VEGF inhibitors:
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.
We will continue to monitor the safety profiles for these VEGF inhibitors. In particular, we will watch whether the FDA mandates any label changes which add warnings about an increased risk of aneurysm and artery dissection for this VEGF inhibitors class of drugs.[View article at original source]