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	<title>Symptom Advice .com &#187; victory</title>
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		<title>With Doubts, FDA Panel Votes For Yaz And Related Contraceptives</title>
		<link>http://symptomadvice.com/with-doubts-fda-panel-votes-for-yaz-and-related-contraceptives/</link>
		<comments>http://symptomadvice.com/with-doubts-fda-panel-votes-for-yaz-and-related-contraceptives/#comments</comments>
		<pubDate>Sat, 17 Dec 2011 05:17:12 +0000</pubDate>
		<dc:creator>Symptom Advice</dc:creator>
				<category><![CDATA[blood symptoms]]></category>
		<category><![CDATA[birth control pills]]></category>
		<category><![CDATA[drugs]]></category>
		<category><![CDATA[expert advisors]]></category>
		<category><![CDATA[food drug administration]]></category>
		<category><![CDATA[victory]]></category>

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		<description><![CDATA[Doubts &#104;&#097;&#118;&#101; been growing &#097;&#098;&#111;&#117;&#116; Yasmin, Yaz and their sister contraceptives for &#115;&#101;&#118;&#101;&#114;&#097;&#108; years &#110;&#111;&#119;. And those doubts reached &#102;&#117;&#108;&#108; flower at &#097; Food Drug Administration advisory panel on Thursday. After hours of circular debate &#097;&#098;&#111;&#117;&#116; &#116;&#104;&#101; safety of this family of oral contraceptives, 15 of &#116;&#104;&#101; FDA&#8217;s 26 expert advisors voted &#116;&#104;&#097;&#116; &#116;&#104;&#101; benefits [...]]]></description>
			<content:encoded><![CDATA[<p></p><p><img src="" style="float:left;clear:both;margin:0 15px 15px 0" />
<p>Doubts &#104;&#097;&#118;&#101; been growing &#097;&#098;&#111;&#117;&#116; Yasmin, Yaz and their sister contraceptives for &#115;&#101;&#118;&#101;&#114;&#097;&#108; years &#110;&#111;&#119;. And those doubts reached &#102;&#117;&#108;&#108; flower at &#097; Food Drug Administration advisory panel on Thursday.</p>
<p>After hours of circular debate &#097;&#098;&#111;&#117;&#116; &#116;&#104;&#101; safety of this family of oral contraceptives, 15 of &#116;&#104;&#101; FDA&#8217;s 26 expert advisors voted &#116;&#104;&#097;&#116; &#116;&#104;&#101; benefits of these birth control pills outweigh &#116;&#104;&#101; risk of dangerous blood clots.</p>
<p>But that&#8217;s &#110;&#111; tub-thumping victory for Bayer. &#105;&#116; &#099;&#114;&#101;&#097;&#116;&#101;&#100; this family of contraceptives, which &#110;&#111;&#119; includes Beyaz and Safyral. They &#099;&#111;&#110;&#116;&#097;&#105;&#110; &#097; hormone called drospirenone that&#8217;s found in none of &#116;&#104;&#101; other two dozen or &#115;&#111; birth control pills available to American women.</p>
<p>And many &#119;&#104;&#111; voted in favor of Bayer&#8217;s drugs expressed &#115;&#101;&#114;&#105;&#111;&#117;&#115; reservations &#098;&#101;&#099;&#097;&#117;&#115;&#101; of &#116;&#104;&#101; risks. &#8220;I voted yes, &#098;&#117;&#116; &#105;&#116; was &#097; difficult vote,&#8221; said Sean Hennessy of &#116;&#104;&#101; University of Pennsylvania. &#8220;I &#116;&#104;&#105;&#110;&#107; &#116;&#104;&#101; drug &#112;&#114;&#111;&#098;&#097;&#098;&#108;&#121; ought to &#098;&#101; rarely used.&#8221;</p>
<p> &nbsp;
<p>Underscoring those doubts, 21 of &#116;&#104;&#101; 26 panelists voted for strengthening &#116;&#104;&#101; warnings on labels of Bayer&#8217;s contraceptives to reflect &#116;&#104;&#101; findings of seven studies &#116;&#104;&#097;&#116; &#116;&#104;&#101; company&#8217;s team had spent much of &#116;&#104;&#101; day &#116;&#114;&#121;&#105;&#110;&#103; to discredit.</p>
<p>One of &#116;&#104;&#101; seven was &#097; 835,000-woman study commissioned &#098;&#121; &#116;&#104;&#101; FDA; &#105;&#116; found &#097;&#098;&#111;&#117;&#116; &#097; two-fold increase in blood clots for Bayer&#8217;s pills compared to competitors&#8217; products.</p>
<p>Nobody&#8217;s completely satisfied &#119;&#105;&#116;&#104; &#116;&#104;&#101; quality of &#116;&#104;&#101; evidence on &#116;&#104;&#101; safety of Bayer&#8217;s contraceptives &#099;&#111;&#110;&#116;&#097;&#105;&#110;&#105;&#110;&#103; drospirenone.</p>
<p>But many pointed out &#116;&#104;&#097;&#116; &#116;&#104;&#101; studies Bayer relies on most to argue for &#116;&#104;&#101; drugs&#8217; safety &#119;&#101;&#114;&#101; paid for &#098;&#121; &#116;&#104;&#101; company. Bayer &#109;&#097;&#107;&#101;&#115; &#097; bundle on its contraceptives, although U.S. sales &#104;&#097;&#118;&#101; fallen sharply since doubts began to &#098;&#101; raised in 2009.</p>
<p>Much of &#116;&#104;&#101; public comment featured people &#119;&#104;&#111; urged &#116;&#104;&#101; FDA to pull Bayer&#8217;s contraceptives off &#116;&#104;&#101; market. &#8220;In &#109;&#121; opinion, absolutely, these drugs should not &#098;&#101; on &#116;&#104;&#101; market &#098;&#101;&#099;&#097;&#117;&#115;&#101; &#116;&#104;&#101;&#114;&#101; &#097;&#114;&#101; safer alternatives,&#8221; said Diana Zuckerman, president of &#116;&#104;&#101; National Research Center for Women and Families, &#097; consumer group.</p>
<p>The most wrenching testimony &#099;&#097;&#109;&#101; &#102;&#114;&#111;&#109; patients &#119;&#104;&#111; &#115;&#097;&#121; they suffered disabling blood clots, and &#102;&#114;&#111;&#109; parents of young women &#119;&#104;&#111; died &#097;&#102;&#116;&#101;&#114; taking these pills.</p>
<p>One of &#116;&#104;&#101;&#109; was Cindy Rippe, &#119;&#104;&#111;&#115;&#101; daughter 20-year-old Elizabeth died &#116;&#104;&#114;&#101;&#101; years ago &#102;&#114;&#111;&#109; pulmonary embolisms two months &#097;&#102;&#116;&#101;&#114; she switched to Yasmin.</p>
<p>&#8220;Elizabeth was &#097; &#118;&#101;&#114;&#121; smart young woman,&#8221; Rippe &#116;&#111;&#108;&#100; &#116;&#104;&#101; panel. &#8220;If Elizabeth had been &#099;&#108;&#101;&#097;&#114;&#108;&#121; warned &#116;&#104;&#097;&#116; Yasmin had &#109;&#111;&#114;&#101; risk – &#109;&#097;&#121;&#098;&#101; twice as much risk as other pills – she &#110;&#101;&#118;&#101;&#114; would &#104;&#097;&#118;&#101; switched to Yasmin – &#110;&#101;&#118;&#101;&#114;. And she would &#098;&#101; alive today.&#8221;</p>
<p>Rippe &#105;&#115; &#097;&#109;&#111;&#110;&#103; 10,000 plaintiffs suing Bayer in cases &#116;&#104;&#097;&#116; &#097;&#114;&#101; to &#098;&#101; tried beginning &#110;&#101;&#120;&#116; month.</p>
<p>It doesn&#8217;t &#104;&#101;&#108;&#112; Bayer&#8217;s case &#116;&#104;&#097;&#116; &#097; &#102;&#111;&#114;&#109;&#101;&#114; FDA commissioner, Dr. David Kessler, has filed &#097;&#110; affidavit in &#097; Chicago federal court accusing Bayer of withholding early reports of blood clots &#102;&#114;&#111;&#109; &#116;&#104;&#101; federal agency back in 2004. Plaintiffs&#8217; lawyers leaked Kessler&#8217;s statement to reporters on &#116;&#104;&#101; eve of this week&#8217;s hearing.</p>
<p>Asked &#097;&#098;&#111;&#117;&#116; withholding of data, Bayer executive Dr Leo Plouffe Jr., said:</p>
<p>&#8220;We&#8217;ve &#097;&#108;&#119;&#097;&#121;&#115; had &#097; &#118;&#101;&#114;&#121; open communication &#119;&#105;&#116;&#104; &#116;&#104;&#101; FDA. We&#8217;ve responded openly to &#097;&#108;&#108; requests for information &#102;&#114;&#111;&#109; &#116;&#104;&#101; FDA. And &#116;&#104;&#101; information we&#8217;re presenting today &#105;&#115; in total openness. I hope &#116;&#104;&#097;&#116; puts &#121;&#111;&#117;&#114; mind at rest.&#8221;</p>
<p>Bayer&#8217;s strongest witness was Dr. Andrea Lukes, &#097; North Carolina gynecologist &#119;&#104;&#111; said &#104;&#101;&#114; patients on drospirenone contraceptives &#111;&#102;&#116;&#101;&#110; &#104;&#097;&#118;&#101; &#108;&#101;&#115;&#115; bloating, acne and breast tenderness.</p>
<p>&#8220;In &#109;&#121; experience,&#8221; Lukes said, &#8220;patients &#119;&#104;&#111; &#098;&#101;&#103;&#105;&#110; Yaz or Yasmin &#097;&#114;&#101; &#108;&#101;&#115;&#115; &#108;&#105;&#107;&#101;&#108;&#121; to change and &#097;&#114;&#101; &#104;&#097;&#112;&#112;&#105;&#101;&#114; &#119;&#105;&#116;&#104; this pill&#8230; drospirenone pills provide &#097;&#110; important and unique role for contraception.&#8221;</p>
<p>That argument had some impact &#119;&#105;&#116;&#104; panel members. Dr, Naomi Tepper of Emory University voted for &#116;&#104;&#101; proposition &#116;&#104;&#097;&#116; drospirenone contraceptives&#8217; benefits outweigh their risks &#098;&#101;&#099;&#097;&#117;&#115;&#101; she was afraid &#116;&#104;&#097;&#116; &#097; no-vote &#8220;would &#109;&#101;&#097;&#110; pulling &#116;&#104;&#101;&#109; &#102;&#114;&#111;&#109; &#116;&#104;&#101; market. And &#105;&#102; &#116;&#104;&#101;&#114;&#101; &#097;&#114;&#101; women &#119;&#104;&#111; &#098;&#101;&#108;&#105;&#101;&#118;&#101; this pill benefits &#116;&#104;&#101;&#109;, &#116;&#104;&#097;&#116; has to &#098;&#101; taken into consideration.&#8221;</p>
<p>But many &#119;&#101;&#114;&#101; unpersuaded &#116;&#104;&#097;&#116; Yasmin and &#104;&#101;&#114; sisters confer &#097;&#110;&#121; special benefits, or at &#108;&#101;&#097;&#115;&#116; not enough to outweigh &#116;&#104;&#101; risks of fatal lung clots or longterm disability &#102;&#114;&#111;&#109; deep-vein thromboses. &#8220;I wouldn&#8217;t recommend this to &#109;&#121; patients and I wouldn&#8217;t &#104;&#097;&#118;&#101; &#109;&#121; daughter take &#105;&#116;,&#8221; said Dr. Peter Kaboli of &#116;&#104;&#101; University of Iowa.</p>
<p>The decision on what to &#109;&#097;&#107;&#101; of &#097;&#108;&#108; this rests &#119;&#105;&#116;&#104; &#116;&#104;&#101; FDA. It&#8217;s expected to strengthen &#116;&#104;&#101; warning labels of these birth control pills – although many panel members worried &#097;&#098;&#111;&#117;&#116; what consumers and doctors &#099;&#097;&#110; &#109;&#097;&#107;&#101; of &#097;&#110; even-more-complicated litany of conflicting studies.</p>
<p>The agency &#115;&#097;&#121;&#115; &#105;&#116; intends to &#100;&#111; &#109;&#111;&#114;&#101; definitive studies on &#116;&#104;&#101; risks of drospirenone contraceptives. &#098;&#117;&#116; one staffer acknowledged &#116;&#104;&#097;&#116; &#105;&#116; hasn&#8217;t identified &#116;&#104;&#101; funds for &#116;&#104;&#097;&#116; &#121;&#101;&#116;.</p></p>
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