Summary Safety Review - Dasatinib - Assessing the Potential Risk of Delayed Growth In Children

• Health Canada’s safety review found a possible link between the use of dasatinib and the risk of delayed growth in children.

• Health Canada will work with the manufacturers to update the product safety information in the Canadian product monograph (CPM) for all dasatinib-containing products to include the risk of delayed growth in children.

Health Canada reviewed the potential risk of delayed growth in children with the use of dasatinib. The safety review was triggered by a labelling update for Sprycel (dasatinib) by the European Medicines Agency.

Dasatinib is not authorized in Canada for use in pediatric patients, but data derived from Canadian sources indicate that it has been prescribed off-label in this population. Sprycel is authorized for use in pediatric patients in the United States and Europe.

• Dasatinib is a prescription drug belonging to a class of drugs called BCR-ABL tyrosine kinase inhibitors that is authorized for sale in Canada to treat adults with certain types of leukemia (cancer in the blood and bone marrow).

• Dasatinib has been marketed in Canada since 2007 under the brand name Sprycel. It is currently available as an oral tablet. Generic versions of dasatinib are also available.

• Approximately 93,000 prescriptions for dasatinib have been dispensed in Canada since 2018, including approximately 600 for use in children.

• Two other drugs in the BCR-ABL tyrosine kinase inhibitors drug class (imatinib and nilotinib) are authorized for use in children for the treatment of certain types of leukemia and the CPM for these drugs includes the risk of delayed growth.

• Health Canada reviewed the available information provided by the manufacturers, and from searches of the Canada Vigilance database^a and the published literature.

• Health Canada reviewed 19 cases (1 Canadian and 18 international) of delayed growth in pediatric patients taking dasatinib. Of the 19 cases, 6 (1 Canadian) were published in the literature. Although confounders (other factors that may have contributed to the occurrence of delayed growth) were present, the evidence reviewed suggests dasatinib treatment could result in delayed growth.

• Health Canada also reviewed 2 clinical study reports submitted by the manufacturer for Sprycel and 4 articles published in the scientific literature. Collectively, the findings from these studies suggest dasatinib treatment could result in delayed growth in pediatric patients. However, there were study limitations, including the presence of confounders and, in some studies, small sample sizes.

• While the cases and studies reviewed had a number of weaknesses, overall, the evidence reviewed was sufficient to support a possible link between the use of dasatinib and the risk of delayed growth in children.

• Health Canada’s review of the available information found a possible link between the use of dasatinib and the risk of delayed growth in children.

• Health Canada will work with the manufacturers to update the CPM of all dasatinib-containing products to include the risk of delayed growth in children.

• Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of dasatinib, and other health products, to the Canada Vigilance Program.

• Health Canada will continue to monitor safety information involving dasatinib, 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 should new health risks be identified.

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 dasatinib both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

1. Canadian reports can be accessed through the Canada Vigilance Online Database.