Other safety alerts
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| Canada: Health Canada has initiated a safety review on Xeljanz and Xeljanz XR (tofacitinib), used to treat arthritis and ulcerative colitis |
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Health Canada announces that it is conducting a safety review of Xeljanz and Xeljanz XR (tofacitinib) after a clinical trial identified an increased risk of serious heart-related issues and cancer in trial participants.
The clinical trial investigated the long-term safety of Xeljanz and Xeljanz XR (tofacitinib) at two doses (5 mg twice a day and 10 mg twice a day) in patients with rheumatoid arthritis, who are at least 50 years of age and have at least one cardiovascular risk factor. Pfizer, the manufacturer of the drug, conducted the trial in multiple countries, including Canada.
Previously, Health Canada had conducted a safety review of this drug after increased risks of blood clots in the lungs and death were discovered during a clinical trial. Following this safety review in 2019, Health Canada worked with Pfizer to update the Canadian labelling for Xeljanz and Xeljanz XR (tofacitinib) to include thrombosis as a warning, and informed Canadians and health care professionals of the findings.
Health Canada is working with Pfizer to evaluate the available safety information for Xeljanz and Xeljanz XR (tofacitinib) and will inform the public of any new safety findings, as needed, once the review is completed.
Information for patients taking Xeljanz/Xeljanz XR (tofacitinib):
- Do not stop or change their dose of Xeljanz or Xeljanz XR (tofacitinib) without first talking to their health care professional.
Information for health care professionals:
- Consider the benefits and risks of Xeljanz and Xeljanz XR (tofacitinib) when deciding whether to prescribe or keep patients on the drug.
- Follow the recommendations in the Xeljanz and Xeljanz XR (tofacitinib) product monograph for the specific condition they are treating.
- Report health or safety concerns.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../75315a-eng.php
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.
Related news on the risk of serious heart-related problems and cancer of tofacitinib was previously issued by the United States Food and Drug Administration (FDA) and Singapore Health Sciences Authority (HSA), and was posted on the Drug Office website on 5 Feb 2021 and 31 Mar 2021. As the review is ongoing, the DH will remain vigilant on its final conclusions and recommendations, and safety update issued by FDA, HSA, Health Canada and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Wednesday, Apr 7, 2021
Issued at HKT 16:00
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