加拿大药监部门报告抗癌药物的罕见、严重皮肤反应

加拿大卫生部发布了一项关于与抗癌药物卡培他滨相关的严重皮肤反应（包括Stevens-Johnson综合征）风险的通告。

根据12月3日在加拿大卫生部网站上发布的一份致医疗卫生专业人士的信函中提供的信息，在接受卡培他滨“治疗期间有非常罕见的严重皮肤反应病例报告，如Stevens-Johnson综合征(SJS)和中毒性表皮坏死松解症(TEN)，一些病例甚至发生死亡结局”。这份信函指出，如患者发生SJS或TEN的体征或症状，应“立即停用” 卡培他滨。

美国食品药品管理局(FDA)尚未发布类似的通告。FDA发言人表示，该机构“持续监测和回顾来自监管机构的报告，尤其关注可影响美国人健康的产品的报告”，目前正在审查关于这一问题的学术信息。该机构“将确定，在必要情况下将采取怎样的措施”。

卡培他滨是一种核苷代谢抑制剂，在加拿大和美国以希罗达为商品名进行销售，用于治疗结直肠癌和乳腺癌。在美国，最初于1998年获准用于治疗转移性乳腺癌，目前已获准用作转移性结肠癌的一线治疗药物，也可作为Dukes’ C期结肠癌的辅助治疗。该产品的销售商为罗氏公司，信函中指出，目前罗氏公司正与加拿大卫生部合作，修改该产品在加拿大的产品手册。在美国市场上还有一种仿制药销售。

美国的卡培他滨说明书的“临床试验报告的皮肤和皮下不良事件”一栏中包含手足综合征（包括2级和3级事件）、皮炎、皮疹和红斑，但未收录关于SJS 或TEN的报告。

应将与卡培他滨相关的严重皮肤事件报告至FDA的MedWatch不良事件报告系统，网址为ww.fda.gov/Safety/MedWatch/default.htm。

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By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network

A notice about the risk of severe skin reactions associated with the cancer drug capecitabine – including Stevens-Johnson syndrome – has been released by the Canadian health department.

"Very rare cases of severe cutaneous reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), in some cases with fatal outcome, have been reported during treatment with" capecitabine, according to a letter to health care professionals, posted on the Health Canada website on Dec. 3. The letter states that treatment with capecitabine should be "immediately discontinued" if a patient develops signs and symptoms of SJS or TEN.

No such notice has been posted by the U.S. Food and Drug Administration. The FDA "constantly monitors and reviews reports from regulatory agencies, especially those concerning products that affect Americans’ health," and is reviewing related scientific information on this issue, an FDA spokesperson said in response to a query on the notice. The agency "will determine what, if any, actions to take," he added.

Capecitabine is a nucleoside metabolic inhibitor, and is marketed as Xeloda in Canada and the United States for treatment of colorectal cancer and breast cancer. In the United States, it was initially approved in 1998 for treating metastatic breast cancer, and is now also approved as a first-line treatment for metastatic colon cancer, as well as for adjuvant colon cancer in patients with Dukes’ C colon cancer. It is marketed by Roche, which the letter says is working with Health Canada to revise the product monograph in Canada. In the United States, a generic formulation is also available.

The U.S. label includes hand-and-foot syndrome (including grade 2 and 3 events), dermatitis, rash, and erythema among the skin and subcutaneous adverse events reported in clinical trials, but there are no reports of SJS or TEN listed.

Serious adverse events associated with capecitabine should be reported to MedWatch, the FDA Safety Information and Adverse Event Reporting Program, at www.fda.gov/Safety/MedWatch/default.htm.