Pancreatitis risk warning added to Canadian labeling for Zelboraf

Health Canada has added a new warning to the Canadian prescribing information for Zelboraf advising patients of pancreatitis risk.

Zelboraf (vemurafenib, Genentech/Daiichi Sankyo) is used to treat adults with melanoma with BRAF^V600E mutation that either cannot be removed in surgery or has spread to other parts of the body, according to a Health Canada alert. Growth of cancer cells is slowed down or stopped with the use of vemurafenib, which is also approved by the FDA for this indication.

A safety review was initiated after 61 reports of pancreatitis were associated with the use of Zelboraf, retrieved from sources including pre-clinical studies, scientific literature, manufacturer’s clinical and safety databases, Health Canada’s Canada Vigilance Program, the World Health Organization database and Health Canada’s Office of Clinical Trails, according to a summary safety review from Health Canada. Zelboraf was deemed to have a possible or probable connection in 10 of the 61 reports, the review reported.

The association between Zelboraf and the occurrence of pancreatitis might be related to the drug possibly stimulating the proliferation of cells leading to obstructive pancreatitis, according to Health Canada.

Patients taking vemurafenib who experience severe pain in their upper abdomen accompanied by nausea, vomiting or abdominal tenderness are advised to quit taking vemurafenib and to talk to their health professional immediately, according to the alert.

Physicians have been advised that patients taking vemurafenib and presenting with unexplained abdominal pain should be assessed for possible pancreatitis. Patients should be closely monitored if restarting vemurafenib, the alert stated.

To report a side effect on a health product, Health Canada advises calling 1-866-234-2345, or going to MedEffect Canada’s web page on Adverse Reaction Reporting for ways to report online, by mail or by fax.

Reference: www.healthycanadians.gc.ca.