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Tysabri Liver Warning
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3-31-2008 8:30 AM
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<div style="margin: 12px 0px; font-family: arial; color: #333333; background: #ffffff; border: solid 4px #e5e5e5; width: 100%; clear: left;"><div class="CM_CTB_Content_Wrap" style="margin: 0px; padding: 0px;background-color: #ffffff;"><div style="border-bottom: solid 1px #dcdcdc; white-space: nowrap; margin-bottom: 8px; background-color: #eeeeee ;background-image: url(http://clipmarks.com/images/source-bg.gif); background-repeat: repeat-x; height: 24px; line-height: 24px; vertical-align: middle; padding-bottom: 4px; color: #666666; font-size: 10px;" ><a href="http://clipmarks.com/clip-to-blog/" title="see clips that are hot right now"><img src="http://content.clipmarks.com/blog_embed/3e8523cc-7262-4a6a-b916-72335c412287/310C5820-CDAF-4DEE-A134-A283EA4BB171/" alt="" width="19" height="19" border="0" style="vertical-align: middle; margin: 0px 4px; display: inline; border: none; float:none;" /></a>clipped from <a title="http://www.fda.gov/medwAtch/safety/2008/safety08.htm" href="http://www.fda.gov/medwAtch/safety/2008/safety08.htm" style="font-size: 11px;">www.fda.gov</a></div><blockquote style="text-align: left; padding: 0px 8px; margin: 4px 0px 8px 0px; background: transparent; border: none;" cite="http://www.fda.gov/medwAtch/safety/2008/safety08.htm"><DL> <A id="skipthis" name="skipthis"> <DT><STRONG></STRONG></DT></A><STRONG><A id="Tysabri" name="Tysabri"></A>Tysabri (natalizumab)</STRONG> <DD><FONT color="red"><STRONG>Audience: </STRONG>Neurologists, other healthcare professionals, patients </FONT><DIV> [Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury. </DIV> [February, 2008 - <A href="http://www.fda.gov/medwAtch/safety/2008/Tysabri_dhcp_letter.pdf">Letter</A> - Biogen Idec, Elan] [January, 2008 - <A href="http://www.fda.gov/medwAtch/safety/2008/Tysabri_PI.pdf">Prescribing Information </A>- Biogen Idec, Elan] </DD><DD><P> <FONT size="2" face="Arial, Helvetica, sans-serif"><A href="#skipthis"><IMG width="1" height="1" border="0" align="bottom" alt="Skip Navigation" src="http://www.fda.gov/medwAtch/safety/2008/../../images/dot_clear.gif" /></A><A href="#quick">Return to Top</A> | <A href="http://www.fda.gov/medwAtch/safety/2008/../../index.html">MedWatch Home</A> | <A href="http://www.fda.gov/medwAtch/safety/2008/../../safety.htm">MedWatch Safety Info</A> | <A href="https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm">Online MedWatch Report </A>| <A href="http://www.fda.gov/medwAtch/safety/2008/../../feedback.htm">Contact MedWatch</A></FONT> </P><HR /><A id="skipthis" name="skipthis"> </A></DD></DL></blockquote></div><div style="margin: 0px 6px 6px 4px;"><table style="font-size: 11px;border-spacing: 0px;padding: 0px;" cellpadding="0" cellspacing="0" width="100%"><tr><td style="background:transparent;border-width:0px;padding:0px;"> </td><td align="right" style="background:transparent;border-width:0px;padding:0px;width:107px" width="107"><a href="http://clipmarks.com/share/310C5820-CDAF-4DEE-A134-A283EA4BB171/blog/" title="blog or email this clip"><img src="http://content9.clipmarks.com/images/c2b-foot.png" border="0" alt="blog it" width="107" height="17" style="border-width:0px;padding:0px;margin:0px;" /></a></td></tr></table></div></div>
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