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The clinical trial
A clinical trial for rheumatoid arthritis compared the Janus kinase (JAK) inhibitor called tofacitinib with other medicines called tumour necrosis factor (TNF) inhibitors.
The trial found an increase in serious side effects with tofacitinib. This included major cardiovascular problems (such as heart attack or stroke), cancer, blood clots in the lungs and in deep veins, serious infections and death. People in the trial were 50 years of age and older and already had at least one cardiovascular risk factor.
Visit the New England Journal of Medicine to read the study Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis.
Products in Australia
The 3 JAK inhibitors available in Australia for chronic inflammatory conditions are baricitinib (Olumiant), tofacitinib (Xeljanz and Xeljanz XR) and upadacitinib (Rinvoq).
They are used to treat at least one of the following conditions:
- rheumatoid arthritis,
- psoriatic arthritis,
- juvenile idiopathic arthritis,
- axial spondyloarthritis,
- ulcerative colitis and
- atopic dermatitis.
Groups of people with higher risk
The results of the clinical trial show that these medicines shouldn’t be used for some groups of people unless there are no suitable treatment alternatives.
Groups of people at higher risk are:
- those aged 65 years or above
- those at increased risk of major cardiovascular problems (such as heart attack or stroke)
- those who smoke or have done so for a long time in the past
- those at increased risk of cancer.
Information for consumers
If you belong to one of these higher risk groups, you should only be prescribed these medicines if there are no suitable treatment alternatives.
If you have any of the risk factors and you take a JAK inhibitor, discuss your current treatment with your prescribing doctor. They may change you to a different treatment depending on your inflammatory disorder. Do not stop the treatment without discussing it with your doctor.
Contact your doctor immediately if you experience any of these symptoms while you are taking a JAK inhibitor:
- chest pain or tightness (which may spread to arms, jaw, neck and back)
- shortness of breath
- cold sweats
- light headedness or sudden dizziness
- weakness in arms and legs
- slurred speech.
Examine your skin regularly and let your doctor know if you notice any new growths on the skin.
If you have any questions or concerns about your treatment, speak to your doctor.
Information for health professionals
The TGA’s Medicine Safety Update for health professionals has more details of our review of this safety issue.
If you are treating patients who are taking a JAK inhibitor for a chronic inflammatory condition, please discuss these risks with your patients. Consider the benefits and risks for each individual before initiating or continuing therapy.
Periodic skin examination is recommended for patients taking these medicines, particularly those with risk factors for skin cancer. Patients should also be regularly re-evaluated to assess for changes in their venous thromboembolism (VTE) risk.
Health professionals managing patients on these medicines will get a letter about this safety issue from the pharmaceutical companies of these 3 JAK inhibitors.
Where to find more safety information
The prescribing information (Product Information or PI) and educational material for patients (Consumer Medicines Information or CMI) for these medicines have been updated. They now include these new recommendations and warnings. Click through to the current PI and CMI documents for these medicines below:
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine