其 他 安 全 警 示
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| Canada: Summary Safety Review: Remicade (infliximab), Humira (adalimumab), Enbrel (etanercept) and Erelzi (biosimilar etanercept): Assessing the potential risk of mycosis fungoides (English only) |
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Health Canada announces that it reviewed the potential risk of mycosis fungoides in patients treated with Tumor Necrosis Factor (TNF) alpha-blockers (or anti-TNF alpha) products following the publication, in the World Health Organization (WHO) Pharmaceutical Newsletter, of mycosis fungoides cases resulting from the administration of infliximab (Remicade) reported by the Australian Therapeutic Goods Administration.
Mycosis fungoides is a type of cancer involving white blood cells, called T-lymphocytes, which grow out of control in the skin. It is a form of cutaneous T-cell lymphoma.
Health Canada's review of information received from the manufacturers and published literature concluded that a link between mycosis fungoides and the use of anti-TNF alpha products could not be confirmed due to limitations in the cases assessed. Mycosis fungoides is a form of lymphoma, which is already included in the Canadian Product Monograph of anti-TNF alpha products.
Health Canada's review of the available information concluded that a link between the risk of mycosis fungoides, a type of lymphoma, and the use of anti-TNF alpha products could not be confirmed given limitations in the available information. As the product safety information for all anti-TNF alpha products already mentions the risk of lymphoma (which includes mycosis fungoides), no updates specific for mycosis fungoides are required at this time.
Health Canada will continue to monitor safety information of all anti-TNF alpha products.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00260
In Hong Kong, there are registered pharmaceutical products containing infliximab (3 products), adalimumab (6 products) and etanercept (4 products). All products are prescription-only medicines. So far, the Department of Health (DH) has received adverse drug reaction related to infliximab (13 cases), adalimumab (15 cases) and etanercept (11 cases), but these cases are not related to mycosis fungoides. The local product information of the above products already include the risk of lymphoma. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Friday, Mar 19, 2021
Issued at HKT 16:00
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