Canadian labelling for all JAK inhibitors to include risks of serious heart-related problems, fatal blood clots and cancer
What the notice records
| Product | Janus Kinase (JAK) inhibitors, including: Cibinqo, Inrebic, Jakavi, Olumiant, Rinvoq and Xeljanz/Xeljanz XR. |
|---|---|
| Issue | Labelling |
| What you should do | Talk to your health care professional for more details about this new safety information.Talk to your health care professional about possible heart disease risk factors before starting a JAK inhibitor.Contact your health care professional immediately and stop taking your JAK inhibitor if you develop symptoms of a heart problem. Symptoms may include:new or worsening chest pain;shortness of breath;irregular heartbeats; orswelling of the legs.Talk to your health care professional if you have or have had any type of cancer before taking a JAK inhibitor.Talk to your healthcare professional if you are a current or past smoker.Be aware that blood clots in the veins of the arms or legs (deep vein thrombosis), arteries (arterial thrombosis) or lungs (pulmonary embolism) can happen in some patients taking a JAK inhibitor. This may be life-threatening and can cause death.Stop taking your JAK inhibitor and seek immediate medical help if you develop any symptoms of a blood clot in your arms or legs (such as swelling, pain or tenderness in the arm or leg), or your lungs (such as sudden unexplained chest pain or shortness of breath).If you are a health care professional: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.To report a side effect to a health product to Health Canada:Call toll-free at 1-866-234-2345.Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax. |
| Category | Drugs |
| Publishing body | Communications and Public Affairs Branch |
| Class | Class not stated |
| Last updated | 2022-11-01 |
Read the official notice on recalls-rappels.canada.ca
Everything in Drugs · Everything from Communications and Public Affairs Branch
Read this correctly
This page reproduces the fields published on the notice and links to the notice itself. It is not a rating and not a statement about a product's current condition, availability or safety.
This notice carries no class in the published data. A blank class means the field is blank — it is not a statement that the product was low risk.
Privacy
This site publishes records that governments already publish. It sets no cookie and makes no request to Google unless you accept one. Read more below.
About this record
Every recall notice published by Health Canada: the product, the issue recorded against it, the class assigned, and the official notice itself. A record of what was published, on the date it was published.
Source: Health Canada — Recalls and safety alerts (open data) — Open Government Licence – Canada. Data refreshes daily. Every page links the row it came from.
What this site is not. It is a copy of an official record. It is not a judgement about any business, building or person, and it is not advice. If the record is wrong, the source above is where it is corrected.