The US Food and Drug Administration (FDA) announces that it is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available. FDA will evaluate the clinical trial results it has received to date and will work with the drug manufacturer to obtain further information as soon as possible. FDA will communicate its final conclusions and recommendations when it has completed its review or has more information to share.
Patients should not stop taking tofacitinib without first consulting with their health care professionals, as doing so may worsen their condition. Talk to their health care professionals if they have any questions or concerns.
Health care professionals should consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue patients on the medicine. Continue to follow the recommendations in the tofacitinib prescribing information.
When FDA first approved tofacitinib, it required the manufacturer, Pfizer, to conduct a safety clinical trial in patients with rheumatoid arthritis (RA) who were taking methotrexate to evaluate the risk of serious heart-related events, cancer, and infections. The trial studied two doses of tofacitinib (5 mg twice daily, which is the approved dosage for RA, and a higher 10 mg twice daily dosage) in comparison to another type of RA medicine called a TNF inhibitor. Patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor. In Feb 2019 and Jul 2019, FDA warned that interim trial results showed an increased risk of blood clots and death with the higher 10 mg twice daily dosage, and as a result, approved a Boxed Warning to the tofacitinib prescribing information. The clinical trial is now complete and initial results show a higher occurrence of serious heart-related events and cancer in RA patients treated with both doses of tofacitinib compared to patients treated with a TNF inhibitor. FDA is awaiting additional results from the trial.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/initial-safety-trial-results-find-increased-risk-serious-heart-related-problems-and-cancer-arthritis
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). All products are registered by Pfizer Corporation Hong Kong Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 8 cases of adverse drug reaction related to tofacitinib, of which one case is related to lung cancer.
Related news on the risk of blood clots of tofacitinib 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 19 Sep 2020. Letters to inform local healthcare professionals were issued by the DH on 29 Jul 2019 and 19 Jun 2020. In Dec 2019, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack or package insert of tofacitinib should include the relevant safety information. As the FDA’s review is ongoing, the DH will remain vigilant on its final conclusions and recommendations, and safety update issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Friday, Feb 5, 2021
Issued at HKT 16:00
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