Skin-cancer drug Zelboraf (vemurafenib): new warning on the risk of pancreatitis

Starting date:
February 12, 2015
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
New safety information, Disease, Important Safety Information
Audience:
General Public, Healthcare Professionals
Identification number:
RA-43697

A new warning has been added to the Canadian prescribing information for the skin-cancer drug Zelboraf (vemurafenib) advising of the risk of pancreatitis.

Zelboraf is used in adults to treat a type of skin cancer (melanoma with a mutation in a specific gene) that either cannot be removed by surgery, or has spread to other parts of the body. It works by targeting proteins made from a gene called BRAF that has mutated.  Zelboraf slows down or stops the growth of cancer cells.

Health Canada has completed a safety review that examined Canadian and international case reports and other data. Cases of drug-induced pancreatitis have been reported with the use of Zelboraf both here and abroad. These drug reactions generally occurred in the first two weeks of Zelboraf treatment.

Pancreatitis is an inflammation of the pancreas. It may range from mild discomfort to a severe, life-threatening illness. Most people with acute (sudden-onset) pancreatitis recover completely with appropriate treatment in a hospital setting.

The Canadian prescribing information (product monograph) has been updated to include the risk of pancreatitis. In addition, Health Canada has published a Summary Safety Review with more information on its review.

What you should do

  • Patients taking Zelboraf who experience severe pain in the upper abdomen (belly), accompanied by nausea, vomiting, or abdominal tenderness, should stop taking Zelboraf and talk to their health professional right away. Pancreatitis is a potentially serious condition requiring medical attention.

Additional information for health professionals

  • Patients taking Zelboraf and presenting an unexplained abdominal pain should be assessed for the possibility of pancreatitis.
  • After an episode of pancreatitis, patients should be closely monitored if re-starting Zelboraf, and dose modification should be considered.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

  • Call toll-free at 1-866-234-2345
  • Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

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