Health Canada announces that it reviewed the available information from searches of the Canada Vigilance databasea, international databases, scientific literature, as well as clinical and observational studies related to the risks of serious heart-related problems, blood clots, cancer and death with Xeljanz/Xeljanz XR, Olumiant and Rinvoq.
The final findings from the clinical research study linked Xeljanz/Xeljanz XR to higher risks of serious heart-related problems, cancer and death, and confirmed the initial findings of an increased risk of blood clots from 2019. These risks have already been reflected in the CPM of Xeljanz/Xeljanz XR. Health Canada also looked at the interim findings from a 2021 observational study with Olumiant, which showed increased rates of serious heart-related problems and blood clots with its use. Given the similar mechanisms of action and indications for Xeljanz/Xeljanz XR, Olumiant and Rinvoq, Health Canada considers that they may have similar risks. Overall, the findings are supportive of the need for precautionary measures with the use of JAK inhibitors for inflammatory conditions.
Health Canada's current review found that a drug class effect for the risks of serious heart-related problems, blood clots, cancer and death with JAK inhibitors used for the treatment of chronic inflammatory diseases cannot be excluded at this time.
As a precautionary measure, Health Canada is working with the manufacturers to update and align these risks in the CPMs for JAK inhibitors indicated for chronic inflammatory diseases.
Health Canada will communicate these updates to healthcare professionals and the public through a Health Product Risk Communication and Public Advisory. Health Canada will continue to monitor safety information involving Xeljanz/Xeljanz XR, Olumiant and Rinvoq, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should new health risks be identified.
Please refer to the following website in Health Canada for details:http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00287
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) which are registered by Pfizer Corporation Hong Kong Limited; 2 products containing baricitinib, namely Olumiant Tablets 2mg (HK-65663) and Olumiant Tablets 4mg (HK-65664) which are registered by Eli Lilly Asia, Inc.; and 2 products containing upadacitinib, namely Rinvoq Prolonged-Release Tablets 30mg (HK-67512) and Rinvoq Prolonged-Release Tablets 15mg (HK-66872) which are registered by Abbvie Limited. All products 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 was related to lung cancer, 3 cases were related to deep vein thrombosis, one case was related to pneumonia, one case was related to herpes zoster disseminated, one case was related to cellulitis and one case was related to disseminated tuberculosis. The DH has received 3 cases of adverse drug reaction related to baricitinib, of which one case was related to deep vein thrombosis. The DH has received 6 cases of adverse drug reaction related to upadacitinib, of which one case was related to lung inflammation, 4 cases was related to herpes zoster and one case was related to cytomegalovirus colitis.
Related news on the risk of blood clots and death 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 12 Feb 2022. 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 products should include safety information about increased risk of blood clots and death with higher dose (10 mg twice daily).
Related news on the risk of serious heart-related problems and cancer of tofacitinib was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 5 Feb 2021, with the latest update posted on 12 Feb 2022. Letters to inform local healthcare professionals were issued by the DH on 15 Jun 2021. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Related news on the risk of blood clots of baricitinib was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 19 Mar 2020, with the latest update posted on 12 Feb 2022. The current local product inserts already contain safety information on the risk of venous thromboembolism.
The DH will remain vigilant on safety updates issued by overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, Sep 17, 2022
Issued at HKT 12:00
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