<body bgcolor="#ffffff" text="#000000"> <a href="http://hyulo.free-best-hosting.com/?fp=hkymyrqyfL%2B9NeeCjrYKQeM4JkRQSg%2BZwQ88NjiV4Kyx2qmSfB%2FkbuaqsulyypAkI8n95PtKW8KaGL524NuFCQ%3D%3D&prvtof=SpNfMLqkwtE1DbFZwogctsuViuP417SH%2FQf%2BJizYhAY%3D&poru=SpfSb5EtG8BThtbiGnpnGWe%2BRCOuLKM5RJp4oEcej4JJiIq0vs99urTtpDNumTdQ81OZDSL%2FoF1QXfqkSjfgymkJrONYaIsQelIP6YD6IXDKtwqfvUpEvkQgMVXRkdk26F31NFH7yZdYzN0rYCnexrYmMW9lsx6U1h3DpT%2Fp73ZejbUXNlsRh7BG4j8VQfzV66pADc77w3aGFvdX6YOsljHJ3vAWTg%2Biiq9JQBItp%2Fp%2FN5mRRxjdVII%2FMuxbWXD131MGnT7v0HKZmMZmqjxtrg%3D%3D&result=aT01NC4xOTYuMzEuMTE3JnU9Q0NCb3QlMkYyLjArJTI4aHR0cCUzQSUyRiUyRmNvbW1vbmNyYXdsLm9yZyUyRmZhcSUyRiUyOSZoPXd3dy4yNC03LW5ld3MuY29tJmhyPXd3dy4yNC03LW5ld3MuY29tJTJGYXJjaGl2ZXMlMkY2MTg1JnJmPQ%3D%3D">Click here to proceed</a>. </body> Yaz Documents Indicate Bayer May Have Pushed Off-Label Use | 24-7-news.com cialis online

Yaz Documents Indicate Bayer May Have Pushed Off-Label Use

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Yaz documents indicate that Bayer might have pushed the Yasmin family of birth control pills for off-label uses. In doing so, drug giant Bayer AG, likely misled women about the drugs’ side effects and health risks.

Company files show that Bayer’s Berlex Laboratories Inc. unit officials touted Yaz to treat all types of premenstrual syndrome; however, the oral contraceptive was only approved in the U.S. for the treatment of PDD—premenstrual dysphoric disorder—a more serious condition than PMS, that causes anxiety, tension, and persistent anger, to name a few.

Sales staff for Berlex, which was acquired in Bayer’s 2006 purchase of Schering AG, discussed a 2006 email from Matt Sample, a Berlex sales consultant, who discussed a Woman’s Day magazine article about Yaz. “This article is a nice way of using YAZ for PMS treatment instead of just focusing on the specific” class of women diagnosed with PDD, said Businessweek, citing the email that is now part of evidence in the case. Sample encouraged sales reps to use the article to ask doctors “what percentage of your patient population suffers from” symptoms seen in PMS versus PDD and “what they think the impact of Yaz will be,” reported Businessweek, citing Bayer emails.

The email and other internal files were released during discovery—the pre-trial evidence exchange—and state that Yaz caused blood clots, heart attacks, and strokes. Businessweek noted that Bayer now faces over 10,000 lawsuits over injuries allegedly linked to Yaz and Yasmin; plaintiff attorneys cite U.S. Food and Drug Administration (FDA) reports of no less than 50 deaths from 2004 to 2008 linked to the drugs.

Bayer is accused of off-label marketing; withholding critical information from patients, doctors, and regulators about increased blood clot risks; and of wrongfully touting Yasmin and Yaz as being as safe as its competitors’ birth-control pills, said Businessweek. Trials are scheduled to begin in January in Illinois and Pennsylvania.

A 2002 email from former Berlex executive, Kimberly Schillace and a contract with gynecologist, Dr. Judith Reichman, a blogger, and women’s health issue expert, and a regular contributor the NBC’s “Today” show are also involved. According to the documents, Schillace wrote that she spoke with Dr. Reichman: “She definitely will mention the off-label benefits of our products…. Attached please find the contract,” the email states; agreement details were not included in the message, said Businessweek. In a 2003 MSNBC.com article, Reichman wrote that some studies state that Yasmin “may be helpful in diminishing PMS-like symptoms”; in her 2005 book, “Slow Your Clock Down,” Reichman said Yasmin may help minimize PMS-related symptoms including “fluid accumulation and bloat” and depression, Businessweek reported.

Bayer promoted Yasmin for uses that did not receive regulatory approval, said NewsInferno, noting that Yasmin and Yaz, are low-estrogen pills made with a type of progestin called drospirenone, known to carry serious health risks. The FDA issued a warning letter to Bayer citing two Yaz commercials that made deceptive claims, and faulting Bayer for overstating the benefits of Yaz and minimizing the drug’s risk of dangerous side effects. Bayer agreed to stop running the offending Yaz ads and began running a “corrective advertising campaign” as a part of an agreement with the FDA and attorneys general in 27 states. The FDA letter said no evidence proves that Yaz can eliminate the PMS symptoms it touts it can treat in its advertisements.

In 2009, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency cited Bayer for a claim that drospirenone “has a positive effect … on fluid retention,” which the agency said was not supported by adequate evidence.

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