Melanoma Drug Zelboraf Linked to Pancreatitis Risk, Canadian Officials Warn

Canadian health officials warn that the side effects of Zelboraf, a prescription medication used to treat late-stage melanoma after the skin cancer has spread, may increase the risk of pancreatitis. 

A drug safety alert was issued by Health Canada on February 12, announcing label changes in that country for the Genentech medication, following a safety review by Canadian health experts.

The Canadian drug regulatory agency indicates that the review found at least 18 cases of pancreatitis linked to Zelboraf in ongoing clinical trials. Of those, seven involved sudden-onset and acute pancreatitis.

The safety review came in the wake of 61 reports of pancreatitis associated with Zelboraf use that came from a variety of sources. At least 10 of those were determined to possibly or probably caused by Zelboraf.

Zelboraf belongs to a class of drugs which target proteins from a mutated gene known as BRAF. These drugs are known as BRAF-inhibitors and at least one other member of the class, Tafinlar, has been linked to pancreatitis.

“Evidence of an association between ZELBORAF and the occurrence of pancreatitis was found by Health Canada,” the warning indicates. “This association may be due, in part, to the fact that the drug may stimulate the proliferation of cells leading to obstructive pancreatitis.”

Zelboraf was approved in the United States in 2011, and the current drug in this country does not appear to carry a similar warning about the risk of pancreatitis.

Health Canada officials warn pancreatitis is a serious condition requiring immediate medical attention and advises patients taking Zelboraf to stop taking the drug and talk to their health care professional if they experience severe pain in the upper abdomen, accompanied by nausea, vomiting, or abdominal tenderness.

Health care professionals are advised to watch patients for unexplained abdominal pain and assess them for the possibility of pancreatitis. Doctors should closely monitor patients if putting them back on Zelboraf after a pancreatitis episode and should consider dose modifications.