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Drugs and Health Products

Summary Safety Review - XALKORI (crizotinib) - Assessing the potential risk of developing a hole in the bowel (gastrointestinal perforation)

May 4, 2017

Product

Xalkori (crizotinib)

Potential Safety Issue

Increased risk of developing a hole in the bowel (gastrointestinal perforation)

Key Messages

  • Xalkori (crizotinib) is a prescription drug authorized for sale in Canada to treat specific types of advanced lung cancers.
  • Health Canada reviewed the potential risk of developing a hole in the bowel (gastrointestinal perforation) with the use of crizotinib because of reports received by the manufacturer.
  • Health Canada’s review of the available information did not establish a link between the use of crizotinib and the risk of developing a hole in the bowel. Health Canada will continue to monitor the safety of crizotinib.

Overview

Health Canada reviewed the potential risk of developing a hole in the bowel (gastrointestinal perforation) with the use of crizotinib because of side effect reports received by the manufacturer as part of their annual review of safety. Gastrointestinal perforation is when a break or hole is formed in the wall of the esophagus, stomach or intestine and may allow food or digested contents to leak out. It is a serious medical event which may be fatal if not found and treated in time. In most cases a patient has to undergo surgery or an invasive procedure to repair the hole. Gastrointestinal perforation is a known risk, associated with the use of some other products in the same class as crizotinib (e.g. sorafenib, regorafenib and axitinib) and it is also mentioned in the safety information for these products.

Use in Canada

  • Crizotinib is a prescription drug authorized for sale in Canada to treat specific types of advanced lung cancer.
  • Crizotinib has been marketed in Canada since 2012 under the brand name Xalkori and is available as capsules taken by mouth.
  • About half of the product sold in Canada each year is used by patients in hospitals

Safety Review Findings

  • At the time of the review, Health Canada did not receive any Canadian reports of the development of a hole in the bowel related to crizotinib use.
  • This safety review looked at information collected by the manufacturer. Included were 32 international reports of the development of a hole in the bowel with the use of crizotinib. In general, the reports did not contain enough information to determine if crizotinib use caused the side effect. The advanced lung cancer itself may have also played a role.
  • While some other products in the same class as crizotinib have been linked to gastrointestinal perforation (e.g. sorafenib, regorafenib and axitinib), Health Canada’s search of the published literature did not find any studies or patient reports of this side effect with the use of crizotinib.

Conclusions and Actions

  • Health Canada’s review of the available information did not establish a link between the use of Xalkori (crizotinib) and developing holes in the bowel.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of this health product.
  • Health Canada will continue to monitor safety information involving crizotinib, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.