| <P style="BACKGROUND: white; MARGIN-BOTTOM: 0pt; TEXT-INDENT: 24pt; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0"><FONT size=3><SPAN lang=EN style="COLOR: #333333; FONT-FAMILY: Arial; mso-ansi-language: en" XML:LANG="EN">5</SPAN><SPAN style="COLOR: #333333; mso-ansi-language: en; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">月</SPAN><SPAN lang=EN style="COLOR: #333333; FONT-FAMILY: Arial; mso-ansi-language: en" XML:LANG="EN">7</SPAN><SPAN style="COLOR: #333333; mso-ansi-language: en; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">日</SPAN><SPAN style="COLOR: #333333; mso-ansi-language: en; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">，美国</SPAN><SPAN lang=EN style="COLOR: #333333; FONT-FAMILY: Arial; mso-ansi-language: en" XML:LANG="EN">FDA</SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">通知公众接受</SPAN><SPAN lang=EN style="COLOR: black; FONT-FAMILY: Arial; mso-ansi-language: en" XML:LANG="EN"><A href="http://www.drugs.com/revlimid.html"><SPAN style="COLOR: black; TEXT-DECORATION: none; text-underline: none"><FONT face=Arial>Revlimid</FONT></SPAN></A></SPAN><SPAN style="COLOR: black; mso-ansi-language: en; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">（</SPAN><SPAN lang=EN style="COLOR: black; FONT-FAMILY: Arial; mso-ansi-language: en" XML:LANG="EN"><A href="http://www.drugs.com/cdi/lenalidomide.html"><SPAN style="COLOR: black; TEXT-DECORATION: none; text-underline: none"><FONT face=Arial>lenalidomide</FONT></SPAN></A></SPAN><SPAN style="COLOR: #333333; mso-ansi-language: en; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">，</SPAN><SPAN style="mso-bidi-font-family: Arial; mso-ascii-font-family: Arial">来那度胺</SPAN><SPAN style="COLOR: #464646">）治疗的</SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">新诊断多发性骨髓瘤患者，产生次发性恶性肿瘤（新类型的癌症）的风险增加。</SPAN> <SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">在</SPAN><SPAN><SPAN lang=EN-US style="COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">Revlimid</SPAN></SPAN><SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">获准</SPAN></SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">后进行的临床试验表明，与安慰剂组相比，以</SPAN><SPAN lang=EN-US style="COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">Revlimid</SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">治疗新诊断患者发生次发性恶性肿瘤的危险性增加。具体地说，这些试验表明，他们发生急性髓细胞性白血病、骨髓增生异常综合征、霍奇金淋巴瘤的风险增加。</SPAN></FONT></P>
<P style="BACKGROUND: white; MARGIN-BOTTOM: 0pt; TEXT-INDENT: 24pt; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0"><FONT size=3><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">这一安全性信息已经添加至</SPAN><SPAN lang=EN-US style="COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">Revlimid</SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">标签的警告和注意事项部分。患者用药指南也已作了更新。医师在决定用给患者处方该药时，应考虑</SPAN><SPAN lang=EN-US style="COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">Revlimid</SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">的这一潜在风险，并对这种风险作监测。</SPAN></FONT></P>
<P style="BACKGROUND: white; MARGIN-BOTTOM: 0pt; TEXT-INDENT: 24pt; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0"><FONT size=3><SPAN lang=EN-US style="COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">FDA</SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">系从美国本土和国外进行的临床试验上述结果的。目前</SPAN><SPAN lang=EN-US style="COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">FDA</SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">目前正在审查所有可能获得的信息，一俟审查完成，即会即时提出新的建议。目前</SPAN><SPAN lang=EN-US style="COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">FDA</SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">不要求停止或限制使用</SPAN><SPAN lang=EN style="COLOR: #333333; FONT-FAMILY: Arial; mso-ansi-language: en" XML:LANG="EN">Revlimid</SPAN><SPAN style="COLOR: #333333; mso-ansi-language: en; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">。</SPAN></FONT></P>
<P style="BACKGROUND: white; MARGIN-BOTTOM: 0pt; TEXT-INDENT: 24pt; mso-line-height-alt: 0pt; mso-char-indent-count: 2.0"><FONT size=3><SPAN lang=EN-US style="COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">Revlimid</SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">用于治疗被称为骨髓增生异常综合征的一类血液疾病，也可与其它药物一起用于治疗多发性骨髓瘤。国内</SPAN><SPAN lang=EN-US style="COLOR: #333333; FONT-FAMILY: Arial" XML:LANG="EN-US">SFDA</SPAN><SPAN style="COLOR: #333333; mso-bidi-font-family: Arial; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial">数据库有新药</SPAN><SPAN style="mso-bidi-font-family: Arial; mso-ascii-font-family: Arial">来那度胺胶囊临床注册记录。</SPAN></FONT> </P>
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