其 他 安 全 警 示
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| Singapore: Risk of major adverse cardiovascular events and malignancies (excluding non-melanoma skin cancer) with use of Xeljanz (tofacitinib) relative to tumour necrosis factor inhibitors (English only) |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Pfizer to inform healthcare professionals of preliminary results from a safety clinical trial which found an increased risk of major adverse cardiovascular events and malignancies (excluding non-melanoma skin cancer) with Xeljanz, compared with tumor necrosis factor inhibitors. Pfizer is working with regulatory agencies to review the full results and analyses as they become available. In addition, Pfizer is conducting additional analyses to further identify any risk factors that might have contributed to the increased risk, which will inform the need for any additional risk mitigation measures.
Healthcare professionals are advised to consider the benefits and risks of Xeljanz when deciding whether to prescribe or continue patients on the medicine and to continue to follow the recommendations in the Xeljanz prescribing information. Healthcare professionals are also recommended to counsel their patients about the risks and benefits of Xeljanz and to advise them not to stop taking Xeljanz without consulting their healthcare professional.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/risk-of-major-adverse-cardiovascular-events-and-malignancies-(excluding-non-melanoma-skin-cancer)-with-use-of-xeljanz-(tofacitinib)-relative-to-tumour-necrosis-factor-inhibitors
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 was previously issued by the United States Food and Drug Administration (FDA), and was posted on the Drug Office website on 5 Feb 2021. As the review is ongoing, the DH will remain vigilant on its final conclusions and recommendations, and safety update issued by FDA, HSA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Wednesday, Mar 31, 2021
Issued at HKT 15:00
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