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	<title>Drug Alert Updates &#187; FDA</title>
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		<title>Psoriasis drug linked to 3 deaths</title>
		<link>http://drugalertupdates.com/2009/12/psoriasis-drug-linked-to-3-deaths/</link>
		<comments>http://drugalertupdates.com/2009/12/psoriasis-drug-linked-to-3-deaths/#comments</comments>
		<pubDate>Thu, 03 Dec 2009 22:38:26 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Raptiva]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[neurological disease]]></category>
		<category><![CDATA[psoriasis]]></category>
		<category><![CDATA[side effects]]></category>

		<guid isPermaLink="false">http://drugalertupdates.com/?p=156</guid>
		<description><![CDATA[According to the FDA, at least 3 people have died due to complications from the psoriasis drug, Raptiva.  Two of the deaths were confirmed to have been caused by progressive multifocal leukoencephalopathy, or PML. All three patients were treated with the drug for more than 3 years.  
In October 2008, Genentech, the marketer [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://drugalertupdates.com/wp-content/uploads/2009/12/img-raptiva.jpg"><img src="http://drugalertupdates.com/wp-content/uploads/2009/12/img-raptiva.jpg" alt="Raptiva" title="Raptiva" width="200" height="133" class="alignleft size-full wp-image-160" /></a>According to the <a href="http://www.reuters.com/article/governmentFilingsNews/idUSWBT01066820090219">FDA</a>, at least 3 people have died due to complications from the psoriasis drug, Raptiva.  Two of the deaths were confirmed to have been caused by progressive multifocal leukoencephalopathy, or PML. All three patients were treated with the drug for more than 3 years.  </p>
<p>In October 2008, Genentech, the marketer of Raptiva, issued a warning to healthcare professionals of the increased risk of PML in patients being administered Raptiva.  This warning was issued after a death was reported in a Raptiva patient.</p>
<p>PML is a rare, neurological disease characterized by progressive damage to the brain.  PML usually affects people with severe immune deficiency and often results in an irreversible decline in neurologic function and death.  Currently, there is no known treatment for PML.</p>
<p>If you or a loved one have taken Raptiva and experienced serious side effects, please contact <a href="http://drugalertupdates.com/topics/raptiva">Drug Alert Updates</a>.  We are here to assist with answering questions and determine if you are eligible for compensation for your injuries.</p>
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		<item>
		<title>Nervous System Disorder linked to Reglan usage</title>
		<link>http://drugalertupdates.com/2009/12/nervous-system-disorder-linked-to-reglan-usage/</link>
		<comments>http://drugalertupdates.com/2009/12/nervous-system-disorder-linked-to-reglan-usage/#comments</comments>
		<pubDate>Thu, 03 Dec 2009 21:08:36 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Reglan]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[side effects]]></category>
		<category><![CDATA[tardive dyskinesia]]></category>

		<guid isPermaLink="false">http://drugalertupdates.com/?p=152</guid>
		<description><![CDATA[Tardive dyskinesia, a syndrome that causes involuntary movements in the lower face, has been associated with the gastrointestinal drug, Reglan.  Reglan is approved for short term (3 month) usage for the treatment of various gastrointestinal diseases.  Common side effects include: repetitive chewing, lip smacking, jaw swinging, impaired finger movements, tongue thrusting and grimacing. [...]]]></description>
			<content:encoded><![CDATA[<p>Tardive dyskinesia, a syndrome that causes involuntary movements in the lower face, has been associated with the gastrointestinal drug, Reglan.  Reglan is approved for short term (3 month) usage for the treatment of various gastrointestinal diseases.  Common side effects include: repetitive chewing, lip smacking, jaw swinging, impaired finger movements, tongue thrusting and grimacing.  </p>
<p>In February 2009, the <a href="http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm142815.htm">FDA</a> required that a “black box” warning about tardive dyskinesia be added to all packaging of Reglan products.  Drug manufacturers are also required to implement a risk evaluation to ensure that patients receiving the drug are fully informed about the risk of developing the side effects.<br />
If you or a loved one have been affected by Reglan, please contact <a href="http://drugalertupdates.com/topics/reglan">Drug Alert Updates</a>.  We will be able to assist you with any questions that you may have and determine if you are eligible for compensation through a Reglan lawsuit.</p>
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		<item>
		<title>Lawsuit filed against Bayer Pharmaceuticals</title>
		<link>http://drugalertupdates.com/2009/11/lawsuit-filed-against-bayer-pharmaceuticals/</link>
		<comments>http://drugalertupdates.com/2009/11/lawsuit-filed-against-bayer-pharmaceuticals/#comments</comments>
		<pubDate>Mon, 30 Nov 2009 22:07:57 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Trasylol]]></category>
		<category><![CDATA[Bayer Pharmaceuticals]]></category>
		<category><![CDATA[birth control]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[renal failure]]></category>

		<guid isPermaLink="false">http://drugalertupdates.com/?p=143</guid>
		<description><![CDATA[A West Virginia man filed a federal lawsuit against Bayer in which he alleges he was not warned of the potential side effects of Trasylol prior to his coronary artery bypass surgery.  As a result, the plaintiff suffers from acute renal failure.  
Trasylol is commonly used to control bleeding in heart surgeries.  [...]]]></description>
			<content:encoded><![CDATA[<p>A West Virginia man filed a federal lawsuit against Bayer in which he alleges he was not warned of the potential side effects of Trasylol prior to his coronary artery bypass surgery.  As a result, the plaintiff suffers from acute renal failure.  </p>
<p>Trasylol is commonly used to control bleeding in heart surgeries.  It was approved by the FDA in 1993, and is a colorless solution administered through an IV during heart surgeries.  When it first appeared on the market, it included a warning about possible anaphylactic reactions, but declined to note the possible links to renal toxicity.</p>
<p>The lawsuit, filed October 20 by James Foster Mathis, alleges he experienced renal failure after he was administered Trasylol on June 28, 2004, before an aortic valve replacement and coronary artery bypass graft.</p>
<p>&#8220;Trasylol was indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass surgery,&#8221; the suit states. &#8220;The effects of Trasylol use in cardiopulmonary bypass surgery involve a reduction in inflammatory response, which translates into a decreased need for allogenic blood transfusions and reduced bleeding.&#8221;</p>
<p>Since Trasylol&#8217;s approval by the FDA in 1993, 4.3 million patients have been subjected to the potentially lethal drug, Mathis claims. In 2005 alone, Trasylol generated about $293 million in sales, the complaint says.</p>
<p>Mathis says he suffered acute renal failure and permanent injuries as a result of his exposure to Trasylol.  Numerous other lawsuits have been filed against Bayer for Trasylol use. </p>
<p>To read the entire article, view the <a href="http://www.wvrecord.com/news/222155-ohio-couple-files-suit-over-bayer-drug-trasylol">West Virginia Record</a>.  </p>
<p>For more information on what you can do if you have been affected by Trasylol, please contact <a href="http://www.drugalertupdates.com/topics/trasylol">Drug Alert Updates</a>.  </p>
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		</item>
		<item>
		<title>Trasylol linked to 1,000 deaths per month</title>
		<link>http://drugalertupdates.com/2009/11/131/</link>
		<comments>http://drugalertupdates.com/2009/11/131/#comments</comments>
		<pubDate>Mon, 30 Nov 2009 16:49:59 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Trasylol]]></category>
		<category><![CDATA[Bayer Pharmaceuticals]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[side effects]]></category>

		<guid isPermaLink="false">http://drugalertupdates.com/?p=131</guid>
		<description><![CDATA[Trasylol, a drug used in one third of all cardiac bypass operations to control bleeding, was on the market for 14 years, possibly contributing to thousands of deaths.  Why did it take Bayer Pharmaceuticals and the FDA 2 years to take the drug off the market?  At the height of the drug’s use, [...]]]></description>
			<content:encoded><![CDATA[<p>Trasylol, a drug used in one third of all cardiac bypass operations to control bleeding, was on the market for 14 years, possibly contributing to thousands of deaths.  Why did it take Bayer Pharmaceuticals and the FDA 2 years to take the drug off the market?  At the height of the drug’s use, it was the probable cause of up to 1,000 deaths per month.</p>
<p>A renowned researcher estimated that up to 22,000 patient’s lives could have been saved if the FDA had removed Trasylol back in 2006 when the studies began.  </p>
<p><a href="http://www.cbsnews.com/stories/2008/02/14/60minutes/main3831900.shtml">60 Minutes</a> shares an insightful video about Joe Randone and his family’s journey to sue Bayer after Joe’s death.  Joe was born with a heart murmur, but went on to lead a normal active life.  In January 2006, Joe checked himself into the hospital for a routine heart valve replacement surgery.  He was told that his surgery had only a 5 percent risk of complications, and he would be able to leave the hospital 5 days after surgery.  </p>
<p>Trasylol was put into Joe’s IV and remained on a steady drip for 4 hours.  After the surgery, his family was told that there had been complications, but the doctors failed to go into detail.  Shortly thereafter, Joe suffered 2 heart attacks and kidney failure.  Randone’s surgeon noted that he suffered from “Aprotinin-induced graft thrombosis”.  Aprotinin is the generic name for Trasylol, and thrombosis means blood clotting.<br />
Joe was able to return home after the surgery, only to have multiple other health problems.  He became so swollen that he couldn’t even shut his eyes.  Joe’s eyes were sewn shut to protect his corneas, his gallbladder had to be removed and his legs had to be amputated due to poor circulation.  Over the course of 8 months, Joe underwent 19 surgeries.</p>
<p>To make matters worse, Joe could have been given two different drugs without the consequences.  Both drugs were found to be effective in studies conducted, without the adverse side effects.  Joe eventually died in August 2006.  </p>
<p>I truly feel that Bayer and the FDA are more concerned about profits than about protecting and maintaining the health of their consumers.  After reading Joe’s story, I almost felt physically sick thinking about the numerous surgeries that his body had to go through, and all for what?  Joe and thousands of other people could be leading perfectly healthy lives now if they had not been given Trasylol during surgery.  It completely astounds me to think that a drug can be put on the market before it is proven to be completely safe.  Studies are conducted to prove the effectiveness of a drug and are tested on a small group of people.  If the drug proves to be effective and safe within the small test group, it will then go on the market.  My question is: who is protecting the consumer if it is not the FDA or the manufacturer of the drug?  The answer remains to be seen.</p>
<p>I urge you to share this story with loved ones and friends, regardless if they have been directly affected by Trasylol or not.  No one should have to suffer through life-threatening health complications after taking this drug.  Please contact <a href="http://www.drugalertupdates.com/topics/trasylol">Drug Alert Updates</a> for more information on Trasylol.</p>
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