February 13, 2015 — Health Canada is warning about the risk of acute pancreatitis from Zelboraf, a popular skin cancer medication.
The safety review was initiated after Zelboraf was linked to 18 cases of pancreatitis in ongoing clinical trials, including 7 cases of sudden-onset (acute) pancreatitis.
In total, 61 cases of pancreatitis have been associated with the use of Zelboraf, including 10 in which Zelboraf was a “possible” or “probable” causal connection.
Health Canada concluded that Zelboraf could stimulate the proliferation of cells inside the pancreas, which could lead to obstructive pancreatitis. This condition occurs when the main pancreatic duct is blocked, causing inflammation.
Health Canada warns:
“Evidence of an association between Zelboraf and the occurrence of pancreatitis was found by Health Canada. This association may be due, in part, to the fact that the drug may stimulate the proliferation of cells leading to obstructive pancreatitis.”
Zelboraf (vemurafenib) was approved by the U.S. Food and Drug Administration (FDA) in August 2011 for the treatment of late-state melanoma (skin cancer) that cannot be removed by surgery. It is specifically indicated for patients who have a gene mutation in the BRAF protein.
Tafinlar, another melanoma drug that targets BRAF, already carries warnings about the risk of pancreatitis. The FDA approved Tafinlar in May 2013.
Symptoms of acute pancreatitis:
- Upper abdominal pain that radiates to the back
- Pain aggravated by eating, especially high-fat foods
- Abdominal swelling and tenderness
- Nausea and vomiting
- Elevated heart rate
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