Canadian labelling for all JAK inhibitors to include risks of serious heart-related problems, fatal blood clots and cancer
CanadaCanadian labelling for all JAK inhibitors to include risks of serious heart-related problems, fatal blood clots and cancer
Recalling Firm: Communications and Public Affairs Branch
Reason for Recall / Hazard
TranslatedLabelling
Product Description & Identification
TranslatedTalk 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.
Affected Products
TranslatedJanus Kinase (JAK) inhibitors, including: Cibinqo, Inrebic, Jakavi, Olumiant, Rinvoq and Xeljanz/Xeljanz XR.
Additional Source Details
| Field | Value |
|---|---|
| N I D | 72146 |
| U R L | https://recalls-rappels.canada.ca/en/alert-recall/canadian-labelling-all-jak-inhibitors-include-risks-serious-heart-related-problems |
| Issue | Labelling |
| Title | Canadian labelling for all JAK inhibitors to include risks of serious heart-related problems, fatal blood clots and cancer |
| Product | Janus Kinase (JAK) inhibitors, including: Cibinqo, Inrebic, Jakavi, Olumiant, Rinvoq and Xeljanz/Xeljanz XR. |
| Archived | 0 |
| Category | Drugs |
| Last updated | 2022-11-01 |
| Organization | Communications and Public Affairs Branch |
| 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. |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Health Canada).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Canadian labelling for all JAK inhibitors to include risks of serious heart-related problems, fatal blood clots and c...?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (Health Canada). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Recalling FirmCommunications and Public Affairs Branch
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