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	<title>Chicago Personal Injury Law Blog - Passen Law Group - Top Chicago, Illinois Personal Injury Lawyers &#187; Product Liability</title>
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	<description>Chicago personal injury law blog published by Passen Law Group -- Top Chicago Personal Injury Lawyers</description>
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		<title>Avastin Breast Cancer Approval Withdrawn</title>
		<link>http://www.passenlaw.com/blog/personal-injury-law/avastin-breast-cancer-approval-withdrawn</link>
		<comments>http://www.passenlaw.com/blog/personal-injury-law/avastin-breast-cancer-approval-withdrawn#comments</comments>
		<pubDate>Wed, 30 Nov 2011 16:30:40 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Medical Malpractice]]></category>
		<category><![CDATA[Personal Injury Law]]></category>
		<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Toxic Exposure]]></category>
		<category><![CDATA[Wrongful Death]]></category>
		<category><![CDATA[Avastin]]></category>
		<category><![CDATA[Breast Cancer]]></category>
		<category><![CDATA[Dangerous Drugs]]></category>

		<guid isPermaLink="false">http://www.passenlaw.com/blog/?p=2515</guid>
		<description><![CDATA[This week, the federal Food and Drug Administration announced its withdrawal of approval for Avastin, a commonly-used breast cancer drug. Avastin, the trade name for the drug bevacizumab, is one of a class of drugs known as “biological therapy.” The drug is a product of Genentech, a biotechnology company based in San Francisco, California. Avastin [...]]]></description>
			<content:encoded><![CDATA[<p><img class="alignright size-medium wp-image-2516" title="avastin" src="http://www.passenlaw.com/blog/wp-content/uploads/2011/11/avastin-300x231.jpg" alt="avastin 300x231 Avastin Breast Cancer Approval Withdrawn" width="300" height="231" />This week, the federal Food and Drug Administration announced its withdrawal of approval for Avastin, a commonly-used breast cancer drug.</p>
<p>Avastin, the trade name for the drug bevacizumab, is one of a class of drugs known as “biological therapy.” The drug is a product of Genentech, a biotechnology company based in San Francisco, California. <strong> </strong></p>
<p><strong> </strong></p>
<p>Avastin is designed to inhibit or prevent the growth of blood vessels which feed cancerous tumors, thus inhibiting or even reversing the growth of the tumors themselves. The drug itself is an antibody, which binds to a specific protein known as vascular endothelial growth factor A. This protein is important in blood vessel growth and development in the human body.</p>
<p>The drug thus works through a process known as anti-angiongenesis. Cancerous tumors over-produce VEGF, which then works to form blood vessels connecting to the tumor, so that the tumor can receive nourishment and grow. The process was developed by Judah Folkman, a recently-deceased surgeon with Harvard Medical School.</p>
<p><strong> </strong></p>
<p>Although the process took a long time to gain credence, there are now at least 10 drugs utilizing anti-angiongenesis sold in the United States, and industry reports reveal that roughly 50 more such drugs are in the development pipeline.</p>
<p>The FDA’s revocation does not extend to Avastin’s other approved uses. <strong>The drug is still approved for the treatment of metastatic colorectal cancer, advanced non-small-cell lung cancers, gliobastoma which has spread even after prior treatments, and certain metastatic kidney cancers.</strong></p>
<p>The FDA’s decision to revoke Avastin’s approval for breast-cancer treatment is based upon what is, to our <a title="drug death lawyer" href="http://www.passenlaw.com/practice-areas/Chicago-products-liability-lawyers"><strong><span style="text-decoration: underline;">drug injury attorneys</span></strong></a>, a particularly troubling combination: lack of effect and dangerous side effects.</p>
<p>First, the drug in fact has no effect on breast cancer. Despite some initial slowing of the growth of breast cancer tumors, patients treated with Avastin did not have an increased survival rate, or live longer, than patients not treated.</p>
<p>Second, the drug triggers a number of extremely serious side effects.</p>
<blockquote><p>Indeed, roughly 1% of Avastin patients died not from breast cancer, but from side effects of Avastin. These side effects include (among others) heart attacks, strokes, and congestive heart failure.</p></blockquote>
<p>Moreover, the company was hardly unaware of the concerns which triggered the removal of approval, even as it continued to market and sell the drug as a breast cancer treatment. Even from the early days of the drug’s approval, there were many questions concerning whether the drug had any meaningful effect on breast cancers. In fact, when the drug was approved, it was despite the 5-to-4 recommendation <strong><em>against </em></strong>approval by an advisory panel. Although the FDA considers the recommendations of its independent advisory panels, it is not bound to do so.</p>
<p>Studies since have simply confirmed what many researchers were already saying: Avastin does not improve patients’ chances of survival, or prolong patients’ lives.</p>
<p>The move to revoke the approval began in July of 2010, when a second advisory panel recommended withdrawal based on further studies showing no benefit. But it took until December of 2010 for the FDA to take any action to begin the withdrawal – action that was fiercely challenged by Genentech. Yet another advisory panel conferred, and took testimony on the matter for two days, eventually voting unanimously to revoke the approval – a vote which did not occur until June of this year.</p>
<p>Our <a title="Chicago injury lawyers" href="http://www.passenlaw.com"><strong><span style="text-decoration: underline;">personal injury attorneys</span></strong></a> are appalled that, even with the overwhelming evidence that Avastin was costing lives, not saving or prolonging them, the company continued to actively market and sell this drug, under the FDA’s approval. There is no excuse for a bureaucratic process lasting nearly a year and a half before this confirmed dangerous drug could be withdrawn.</p>
<p><strong>If you have any questions about a possible serious injury or  wrongful death claim,   please   give us a call us at 312-527-4500 or   email   us at         info@passenlaw.com  for a complimentary  consultation.  You can also           learn more by  following us on <a title="Pasen Law Group Twitter page" href="http://www.twitter.com/PassenLaw">Twitter</a>, reviewing our <a title="Mattt Passen Chicago attorney" href="http://www.linkedin.com/profile/view?id=36686708&amp;trk=tab_pro">LinkedIn </a>or <a title="Mattt Passen Chicago attorney " href="http://www.avvo.com/attorneys/60601-il-matthew-passen-1095618.html?ref=header">Avvo.com</a> pages, and by reviewing our website.</strong></p>
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		<title>Merck Continues Developing Vorapaxar Despite Dangers</title>
		<link>http://www.passenlaw.com/blog/personal-injury-law/merck-continues-developing-vorapaxar-dangers</link>
		<comments>http://www.passenlaw.com/blog/personal-injury-law/merck-continues-developing-vorapaxar-dangers#comments</comments>
		<pubDate>Sun, 20 Nov 2011 15:36:13 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Personal Injury Law]]></category>
		<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Dangerous Drug Injury]]></category>
		<category><![CDATA[Pharmaceutical Drugs]]></category>
		<category><![CDATA[Product Liability Lawyer]]></category>

		<guid isPermaLink="false">http://www.passenlaw.com/blog/?p=2498</guid>
		<description><![CDATA[Even in the face of disturbing developments concerning its experimental anti-clotting drug Vorapaxar, pharmaceutical giant Merck has shown a disturbing intent to proceed with development of this dangerous product. Vorapaxar was once considered the most important drug in the development pipeline. In fact, as recently as 2009, Wall Street analysts predicted that the drug could [...]]]></description>
			<content:encoded><![CDATA[<p><img class="alignright size-medium wp-image-2500" title="Voraxapar dangers" src="http://www.passenlaw.com/blog/wp-content/uploads/2011/11/Voraxapar-dangers-300x200.jpg" alt="Voraxapar dangers 300x200 Merck Continues Developing Vorapaxar Despite Dangers" width="300" height="200" />Even in the face of <a href="http://www.marketwatch.com/story/mercks-vorapaxar-fails-to-meet-study-goal-2011-11-13">disturbing developments </a>concerning its experimental anti-clotting drug Vorapaxar, pharmaceutical giant Merck has shown a disturbing intent to proceed with development of this <a title="dangerous product lawyer" href="http://www.passenlaw.com/practice-areas/Chicago-products-liability-lawyers"><strong><span style="text-decoration: underline;">dangerous product</span></strong></a>.</p>
<p><strong> </strong></p>
<p>Vorapaxar was once considered the most important drug in the development pipeline. In fact, as recently as 2009, Wall Street analysts predicted that the drug could generate $3 billion in annual sales for the company.</p>
<p>But prospects have lessened since.</p>
<p>In January, the drug underperformed in a large safety study, causing excess bleeding in patients who had previously suffered a stroke. Now, the drug’s performance in a new study known as the Tracer study has further dented its prospects.</p>
<p>The new study was designed to test the drug’s ability to improve various cardiovascular problems, including heart attack, stroke, chest pain, the need for artery clearing, and cardiovascular death. And, in fact, patients on the drug in the Tracer study did see a lower rate of heart attacks.</p>
<p>But the slight decrease in the overall risk of cardiovascular problems was not statistically significant. Moreover, the drug continued to show problems with excess bleeding.</p>
<blockquote><p>Patients on vorapaxar had an almost 40 percent increase in bleeding. These patients also had a rate of intracranial hemorrhage three times that of the control group. And as patients remained on the drug, the risk of bleeding only increased over time.</p></blockquote>
<p>One would think that, in light of these results, Vorapaxar would be finished. But, even after the results of the Tracer study were announced, Merck announced its intention to continue pursuing the drug. The company said it was waiting on the results of another large study of the drug, and that the “bleeding needs to be understood more” before a final decision could be made.</p>
<p>Our <a title="product liability lawyer" href="http://www.passenlaw.com/practice-areas/Chicago-products-liability-lawyers"><strong><span style="text-decoration: underline;">product liability attorneys</span></strong></a> are troubled by the company’s attitude towards these results. Excessive bleeding and intracranial hemorrhage are extremely serious, and often deadly, side effects.</p>
<p>We urge Merck to suspend development of this dangerous drug immediately. Should the drug proceed to market despite the company’s knowledge of the dangers, as confirmed in multiple studies, Merck will be responsible for the unnecessary injuries and deaths caused as a result.</p>
<p><strong>If you have any questions about a serious injury or wrongful death claim,   please   give us a call us at 312-527-4500 or  email   us at         info@passenlaw.com  for a complimentary consultation.  You can also           learn more by  following us on <a title="Pasen Law Group Twitter page" href="http://www.twitter.com/PassenLaw">Twitter</a>, reviewing our <a title="Mattt Passen Chicago attorney" href="http://www.linkedin.com/profile/view?id=36686708&amp;trk=tab_pro">LinkedIn </a>or <a title="Mattt Passen Chicago attorney " href="http://www.avvo.com/attorneys/60601-il-matthew-passen-1095618.html?ref=header">Avvo.com</a> pages, and by reviewing our website.</strong></p>
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		<title>Dangerous Nurofen Plus Tablets Recalled</title>
		<link>http://www.passenlaw.com/blog/personal-injury-law/nurofen-tablets-replaced</link>
		<comments>http://www.passenlaw.com/blog/personal-injury-law/nurofen-tablets-replaced#comments</comments>
		<pubDate>Tue, 20 Sep 2011 15:14:46 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Personal Injury Law]]></category>
		<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Defective Products]]></category>

		<guid isPermaLink="false">http://www.passenlaw.com/blog/?p=2322</guid>
		<description><![CDATA[Recently, regulators in Great Britain issued a safety alert after finding packets of Nurofen Plus, an over-the-counter painkiller, containing the anti-psychotic prescription drug Seroquel XL instead. After additional packs were found, from other batches, containing both Seroquel XL and Neurontin, an anti-seizure prescription medication, the manufacturer issued a recall of all outstanding unsold packets of [...]]]></description>
			<content:encoded><![CDATA[<p><img class="alignright size-medium wp-image-2323" title="NuforenPlus" src="http://www.passenlaw.com/blog/wp-content/uploads/2011/09/NuforenPlus-300x174.jpg" alt="NuforenPlus 300x174 Dangerous Nurofen Plus Tablets Recalled" width="300" height="174" />Recently, regulators in <a href="http://www.guardian.co.uk/science/2011/aug/25/nurofen-plus-warning-anti-psychotic-drugs">Great Britain issued a safety alert</a> after finding packets of Nurofen Plus, an over-the-counter painkiller, containing the anti-psychotic prescription drug Seroquel XL instead. After additional packs were found, from other batches, containing both Seroquel XL and Neurontin, an anti-seizure prescription medication, the manufacturer issued a recall of all outstanding unsold packets of Nurofen Plus.</p>
<p>Nurofen Plus contains a combination of codeine and ibuprofen. Its availability in the U.S. varies by state &#8211; in some places it requires a prescription, while in others it can be obtained over-the-counter with identification, as with pseudoephedrine.</p>
<p><a href="http://www.drugs.com/uk/seroquel-xl-50mg-200mg-300mg-400mg-prolonged-release-tablets-1227.html">Seroquel XL</a>, by contrast, is the brand name for the drug Quetiapine, a powerful anti-psychotic with extreme side effects. The drug is used to treat schizophrenia, bipolar disorder, or “off-label” for a host of other psychiatric conditions.</p>
<blockquote><p>Known side effects include circulatory problems, somnolence, sluggishness, fatigue, dry mouth, sore throat, dizziness, abdominal pain, constipation, upset stomach, orthostatic hypotension, inflammation in the sinuses or pharynx, increased appetite, and weight gain. There is also some data suggesting that Seroquel XL may cause cataracts. Prolonged used can also result in tardive dyskinesia, a neurological condition with no known cure or, in rare cases, neuroleptic malignant syndrome. Neurontin is known to cause a similar array of side effects.</p></blockquote>
<p>It is still not known how this packaging mix-up occurred. Indeed, the medicines involved look nothing like one another, and all three drugs are manufactured by different companies. There have been a number of suggestions, ranging from manufacturer negligence to deliberate tampering by the company’s opponents, but nothing is yet proven. It is thus unknown whether there might be any legal liability associated with this mishap.</p>
<p>Although the company has recalled all unsold batches, there is as yet no indication as to whether any mispackaged batches were shipped to or sold in the United States. We therefore urge any customers with Nurofen Plus to carefully check all the pills in their package to ensure that the medication is correct. If a mispackaged pill is found, contact the company, and the FDA, immediately</p>
<p>Many physicians have stated that taking a single dose of Seroquel XL would not be dangerous. Our <a title="drug injury lawyer" href="http://www.passenlaw.com/practice-areas/Chicago-products-liability-lawyers">drug injury attorneys</a> are not so sure.</p>
<p>First and foremost, a patient who does not expect the severe drowsiness associated with a first dose of Seroquel XL could get behind the wheel or operate other heavy machinery, leading to fatal or disastrous results. Further, there is the very real possibility of harmful drug interactions.</p>
<p>Seroquel XL, like many anti-psychotics, is thought to lower the seizure threshold in patients, who are thus advised to avoid bupropion and other drugs which do likewise. Similarly, Seroquel XL, when used in combination with alcohol, or when the patient tries to fight the sedative effect of the drug instead of going to sleep, can trigger sleep paralysis, lucid dreaming, hallucinations, and out of body experiences</p>
<p>Mercifully, thus far there have been no reports of injuries or deaths from the packaging problem. Our<strong></strong> <a title="Chicago injury lawyer" href="http://www.passenlaw.com">Chicago  injury attorneys</a> hope that this continues, but urge all consumers to be beyond cautious with any recently-purchased packages of Nurofen Plus. Although lawsuits can bring compensation for your injuries, there is no substitute for staying safe.</p>
<p><strong>To speak with an experienced</strong><strong> </strong>trial attorney with Passen Law Group about an injury caused by a dangerous drug or for some other serious injury matter, call us at (312) 527-4500 or fill out a free case evaluation on our website.</p>
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