Health Canada announces that the Canadian labelling for all Janus Kinase (JAK) inhibitors is being updated to include the risks of serious heart-related problems, fatal blood clots and cancer. This is being done as a precautionary measure. To date, Canadian labelling for the drugs Cibinqo (abrocitinib), Inrebic (fedratinib), Olumiant (baricitinib), Rinvoq (upadacitinib) and Xeljanz/Xeljanz XR (tofacitinib) have been revised. Health Canada is working with the manufacturer of Jakavi (ruxolitinib) to update its Canadian labelling.
JAK inhibitors are prescription drugs authorized for sale in Canada for various inflammatory disorders, certain blood cancers and graft-versus-host disease.
These labelling updates are the result of a number of safety reviews conducted by Health Canada. In 2020 and 2021, Health Canada assessed and confirmed the risks of serious heart-related problems, fatal blood clots, and cancer with Xeljanz/Xeljanz XR. The Department also assessed whether these risks would apply to Olumiant and Rinvoq, which are also used for inflammatory conditions. Based on these findings and how these drugs work, Health Canada cannot rule out these risks for other JAK inhibitors. Therefore, as a precautionary measure, Health Canada is working with manufacturers to ensure Canadian labelling of all JAK inhibitors includes these risks.
Health care professionals are advised:
- Consider the benefits and risks, and consult the safety information in the Canadian labelling, prior to initiating or continuing therapy with a JAK inhibitor, particularly in geriatric patients, in patients who are current or past smokers, those with other cardiovascular or malignancy risk factors or an underlying malignancy, those who develop a malignancy, and in patients who may be at increased risk of thrombosis.
- Inform patients that JAK inhibitors may increase their risk of major adverse cardiovascular events, including non-fatal myocardial infarction. Instruct all patients, especially geriatric patients, current and past smokers, and patients with other cardiovascular risk factors, to be alert for the symptoms of stroke and cardiovascular events.
- Advise patients to stop taking their JAK inhibitor and seek immediate medical help if they develop symptoms of a heart problem.
- Inform patients that JAK inhibitors may increase their risk for certain cancers, such as lung cancer and lymphoma. Instruct patients to inform their healthcare provider if they have a history of any type of cancer.
- Advise patients to stop taking their JAK inhibitor and to seek immediate medical help if they experience any symptoms of thrombosis.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/canadian-labelling-all-jak-inhibitors-include-risks-serious-heart-related-problems
In Hong Kong, there are 3 registered pharmaceutical products containing tofacitinib, namely Xeljanz Tablets 5mg (HK-63303), Xeljanz XR Extended Release Tablets 11mg (HK-66141) and Xeljanz Tablets 10mg (HK-66833) which are registered by Pfizer Corporation Hong Kong Limited; 2 products containing baricitinib, namely Olumiant Tablets 2mg (HK-65663) and Olumiant Tablets 4mg (HK-65664) which are registered by Eli Lilly Asia, Inc.; 2 products containing upadacitinib, namely Rinvoq Prolonged-Release Tablets 15mg (HK-66872) and Rinvoq Prolonged-Release Tablets 30mg (HK-67512) which are registered by Abbvie Limited; and 4 products containing ruxolitinib, namely Jakavi Tab 20mg (HK-61972), Jakavi Tab 5mg (HK-61973), Jakavi Tab 15mg (HK-61974) and Jakavi Tablets 10mg (HK-66148) which are registered by Novartis Pharmaceuticals (HK) Limited. All products are prescription-only medicines. There is no registered pharmaceutical product containing abrocitinib or fedratinib.
So far, the Department of Health (DH) has received adverse drug reaction related to tofacitinib (9 cases; of which 2 cases were related to cancer and 3 cases were related to deep vein thrombosis), baricitinib (3 cases; of which one case was related to deep vein thrombosis), upadacitinib (6 cases) and ruxolitinib (22 cases; of which one case was related to chronic myeloid leukaemia).
Related news on the risk of blood clots, serious heart-related problems and cancer of JAK inhibitors was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 26 Feb 2019, with the latest update posted on 29 Oct 2022. Letters to inform local healthcare professionals were issued by the DH on 29 Jul 2019, 19 Jun 2020, 15 Jun 2021, 2 Sep 2021 and 31 Oct 2022.
In Dec 2019, the Registration Committee of the Pharmacy and Poisons Board (the Committee) discussed the matter on the risk of blood clots and death associated with the use of tofacitinib, and decided that the sales pack or package insert of tofacitinib products should include safety information about increased risk of blood clots and death with higher dose (10 mg twice daily).
In Dec 2021, the Committee discussed the matter on the risk of venous thromboembolic events (including deep vein thrombosis and pulmonary embolism) associated with the use of tofacitinib, baricitinib and ruxolitinib, and decided that the sales pack or package insert of these products should include the relevant safety information.
As previously reported, the matter will be further discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Nov 2, 2022
Issued at HKT 12:30
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