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 <title>Roche warns of Tamiflu psych effects</title>
 <link>http://www.fiercepharma.com/story/roche-warns-of-tamiflu-psych-effects/2008-03-05?utm_medium=rss&amp;utm_source=rss&amp;cmp-id=OTC-RSS-FP0</link>
 <description>&lt;p&gt;
After some arm-twisting from the FDA, Roche has added stronger warnings to its Tamiflu label. In a Dear Healthcare Professional letter, the company cautioned doctors about the sometimes-fatal psychiatric problems seen in a small number of patients. Some have gone delirious and hurt themselves, even killed themselves, by falling from windows or balconies or running into traffic.
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&lt;p&gt;
An FDA advisory committee discussed the problems at a &lt;a href=&quot;http://www.fiercepharma.com/story/new-drug-warnings-poised-rollout/2007-11-29&quot;&gt;November meeting&lt;/a&gt;, where the agency revealed nearly 600 reports of psychiatric troubles in Tamiflu patients, three-fourths of them in Japan. But because the flu itself can cause delirium and hallucinations, the new Tamiflu label states that the drug hasn&#039;t been definitively linked to the behavior problems.
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Now, Australian regulators say they&#039;re keeping an eye on Tamiflu. They&#039;ve updated the labeling for the drug, too.
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&lt;p&gt;
- read the &lt;a href=&quot;http://www.forbes.com/feeds/ap/2008/03/04/ap4728042.html&quot;&gt;story&lt;/a&gt; in &lt;em&gt;Forbes&lt;/em&gt;&lt;br /&gt;
- check out the Australian &lt;a href=&quot;http://news.theage.com.au/drug-regulator-keeps-watch-on-flu-drug/20080305-1x3r.html&quot;&gt;reaction&lt;/a&gt; in &lt;em&gt;The Age&lt;/em&gt;
&lt;/p&gt;
&lt;p&gt;
&lt;strong&gt;Related Articles:&lt;br /&gt;
&lt;/strong&gt;Tamiflu resistant to seasonal strains. &lt;a href=&quot;http://www.fiercepharma.com/story/tamiflu-resistant-seasonal-strains/2008-01-29&quot;&gt;Report&lt;/a&gt;&lt;br /&gt;
FDA does a triple-take on Tamiflu. &lt;a href=&quot;http://www.fiercepharma.com/story/fda-does-triple-take-tamiflu/2007-11-26&quot;&gt;Report&lt;/a&gt;&lt;br /&gt;
Tamiflu&#039;s Japanese sales to drop by half. &lt;a href=&quot;/story/tamiflu-s-japanese-sales-to-drop-by-half/2007-11-06?utm_medium=nl&amp;amp;utm_source=linkhttp://www.fiercebiotech.com/story/sanofi-signs-stem-cell-pact-china/2007-09-14&quot;&gt;Report&lt;/a&gt;&lt;br /&gt;
Roche&#039;s Tamiflu ads spark criticism. &lt;a href=&quot;http://www.fiercebiotech.com/story/roche-s-tamiflu-ads-spark-criticism/2006-11-01&quot;&gt;Report&lt;/a&gt;&lt;br /&gt;
EU approves Tamiflu for children. &lt;a href=&quot;http://www.fiercebiotech.com/story/eu-approves-tamiflu-for-children/2006-01-31&quot;&gt;Report&lt;/a&gt;
&lt;/p&gt;
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 <comments>http://www.fiercepharma.com/story/roche-warns-of-tamiflu-psych-effects/2008-03-05#comments</comments>
 <category domain="http://www.fiercepharma.com/tags/fda">FDA</category>
 <category domain="http://www.fiercepharma.com/tags/japan">Japan</category>
 <category domain="http://www.fiercepharma.com/tags/regulators">Regulators</category>
 <category domain="http://www.fiercepharma.com/tags/roche">Roche</category>
 <category domain="http://www.fiercepharma.com/tags/side-effects-fda-warning">side effects. FDA warning</category>
 <category domain="http://www.fiercepharma.com/tags/tamiflu">Tamiflu</category>
 <pubDate>Wed, 05 Mar 2008 06:59:55 -0500</pubDate>
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