The US Food and Drug Administration (FDA) announces that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis.
In this ongoing safety trial required by FDA when it approved tofacitinib for RA, the drug manufacturer, Pfizer, is transitioning patients who were on the high 10 mg twice daily dose to the lower, currently approved dose of 5 mg twice daily. This trial will continue and is expected to be completed by the end of 2019. FDA is working with the manufacturer to evaluate other currently available safety information for tofacitinib and will update the public with any new information based on our ongoing review.
Health care professionals should follow the recommendations in the tofacitinib prescribing information for the specific condition they are treating. Monitor patients for the signs and symptoms of pulmonary embolism, and advise them to seek medical attention immediately if they experience them.
Patients should not stop or change their dose of tofacitinib without first talking to their health care professional, as doing so may worsen their condition. Patients taking tofacitinib should seek medical attention immediately if they experience symptoms of a blood clot in their lungs or other unusual symptoms such as sudden shortness of breath or difficulty breathing, chest pain or pain in their back, coughing up blood, excessive sweating, clammy or bluish colored skin.
When FDA first approved tofacitinib, it required a clinical trial among patients with RA to evaluate the risk of heart-related events, cancer, and opportunistic infections with the medicine at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor. RA patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor. During the most recent analysis of the trial, an external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm631871.htm
In Hong Kong, Xeljanz Tablets 5mg (HK-63303) is a registered pharmaceutical product containing tofacitinib. The product is registered by Pfizer Corporation Hong Kong Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to tofacitinib, but these cases are not related to blood clots in the lungs. As the safety trial is ongoing, DH will remain vigilant on the results of the trial and safety update issued by FDA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Tuesday, Feb 26, 2019
Issued at HKT 17:00
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