The skin-cancer drug Zelboraf (vemurafenib) is associated with a risk of pancreatitis, Health Canada warns. According to a safety alert posted on the regulator’s website Thursday, the drug’s prescribing information has been updated to reflect this risk.
Zelboraf is used to treat a specific type of skin cancer in adults that is not able to be removed via surgery or has spread to other parts of the body. The type of cancer it treats is a melanoma with a mutation in an specific gene. The drug slows down or halts the growth of cancer cells by targeting proteins made from a mutated version of the BRAF gene.
In a safety review, Health Canada looked at Canadian and international case reports along with other data. In both Canada and abroad, there were cases of drug-induced pancreatitis associated with the use of Zelboraf; a total of 61 cases were identified. “These drug reactions generally occurred in the first two weeks of Zelboraf treatment.” the agency stated.
The review was launched after 18 cases of pancreatitis were linked to Zelborag; 7 of these cases involved acute (sudden onset) pancreatitis. Health Canada concluded from the review that “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.”
Pancreatitis, or inflammation of the pancreas, can be a mild or life-threatening condition. Patients taking Zelboraf should contact their healthcare professional immediately if they experience severe pain in the upper abdomen (belly), along with nausea, vomiting or abdominal tenderness.