Health Canada is conducting a safety review after issues were discovered during a clinical trial involving rheumatoid arthritis patients being treated with the drug tofacitinib (sold in Canada under the brand names Xeljanz and Xeljanz XR).
Tofacitinib is a prescription drug used to treat adults with moderate to severely active rheumatoid arthritis, active psoriatic arthritis, or moderate to severely active ulcerative colitis in people who do not respond well to other medications. It is generally prescribed in combination with other drugs, such as methotrexate.
The ongoing clinical trial, run by Pfizer, found an increased risk of blood clots in the lungs and of death when the drug was taken at a high dose of 10 mg, twice a day. Patients who were taking 10 mg of tofacitinib twice a day are now transitioning to the lower, currently authorized dose of 5 mg twice a day.
Health Canada has not authorized the high dose of 10 mg twice a day for rheumatoid arthritis or psoriatic arthritis; this dose is authorized only for patients with ulcerative colitis in people who do not respond well to other medications. For patients with ulcerative colitis, the Canadian prescribing information recommends that patients use the lowest effective dose possible for maintenance therapy, to lower the risk of adverse reactions.
Please refer to the following website in Health Canada for details:http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../69336a-eng.php
In Hong Kong, Xeljanz Tablets 5mg (HK-63303) and Xeljanz XR Extended Release Tablets 11mg (HK-66141) are registered pharmaceutical products containing tofacitinib. Both products are registered by Pfizer Corporation Hong Kong Limited, and are prescription-only medicines, indicated only for treatment of rheumatoid arthritis at the dose of 5 mg twice a day. 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.
Related news was previously issued by US Food and Drug Administration (FDA), and was posted on the Drug Office website on 26 Feb 2019. As the safety trial is ongoing, DH will remain vigilant on the results of the trial and safety update issued by FDA, Health Canada and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, March 16, 2019
Issued at HKT 12:00
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