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Zelboraf Pancreatitis Side Effect Warning Issued in Canada

Zelboraf Pancreatitis Side Effect Warning Issued in Canada

February 13, 2015 — The skin cancer drug Zelboraf has been linked to 61 cases of pancreatitis (pancreas inflammation), according to a warning from Health Canada.

Zelboraf (vemurafenib) was approved by the U.S. Food and Drug Administration (FDA) in August 2011. It is used for the treatment of late-stage melanoma, the most deadly type of skin cancer, in patients who cannot be cured with surgery.

Zelboraf slows down or stops the growth of cancer cells by targeting the BRAF protein. Unfortunately, it may also cause cells in the pancreas to proliferate, which could potentially lead to obstructive pancreatitis.

This type of pancreatitis occurs when the main pancreatic duct is blocked, resulting in sudden or chronic inflammation of the pancreas.

Health Canada opened a safety investigation into the risk after there were 18 cases of pancreatitis in ongoing clinical trials, including 7 cases of acute pancreatitis (sudden onset). A review of medical literature and studies identified 61 cases of pancreatitis associated with Zelboraf, including 10 cases in which a causal connection was “possible” or “probable.”

The safety agency warns:

“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.”

Tafinlar (dabrafenib), another melanoma drug that targets BRAF, was previously associated with pancreatitis and carries warning about the side effect on the label. Tafinlar has been approved in the United States since May 2013.

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