Yourlawyer.com (Yasmin-Survivors-Video News) http://www.yourlawyer.com/topics/overview/Yasmin-Survivors-Forum-Video Sat, 19 Apr 2014 23:14:25 -0400 Sat, 19 Apr 2014 23:14:25 -0400 pixel-app en Yaz, Yasmin Blood Clot Risk Prompts Push for Stricter Warnings http://www.yourlawyer.com/articles/title/yaz-yasmin-blood-clot-risk-prompts-push-for-stricter-warnings Wed, 07 Dec 2011 00:00:00 -0500 http://www.yourlawyer.com/articles/title/yaz-yasmin-blood-clot-risk-prompts-push-for-stricter-warnings U.S. Food & Drug Administration (FDA)  reviewers are pushing for stronger blood clot warnings for Yaz, Yasmin, and other birth control pills that contain drospirenone.  In a report posted on the agency website yesterday, FDA reviewers said that evidence linking Yaz, Yasmin and similar oral contraceptives to an increased risk of blood clots is conflicting, but could not be ruled out.

The FDA report was released in advance of tomorrow's joint meeting for the FDA's Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.   The advisors will vote on whether to recommend new warnings for pills with drospirenone.

Yaz and Yasmin have been named in more than 10,000 lawsuits alleging Bayer AG neglected to appropriately warn patients and doctors about increased health risks associated with the drugs.  Thousands of those lawsuits have been consolidated the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100), currently pending before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.

The FDA has been reviewing Yaz and Yasmin for sometime, and over the last two years several large, independent studies have suggested the rate of blood clots with drospirenone-containing drugs is higher than with other hormone-based contraceptives. Last month, the agency reported its own study found that women who use such were 75 percent more likely to experience clots compared to those taking other oral contraceptives. Other studies reviewed by the agency have reached conflicting conclusions, with some pointing to higher risk, and others not.

However, two studies published in 2007, conducted as part of the postmarketing requirements of the FDA or European regulators, did not find any difference in blood clotting between drospirenone and levonorgestral.  Both of those studies were funded by Bayer.

In addition to Yaz and Yasmin, drospirenone is found in birth control pills sold under the names Ocella, Safyral, Syeda, Zarah, Beyaz, Gianvi, and Loryna.
 

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Yasmin Lawsuit Documents Reveal Bayer Concealed Blood Clot Risks http://www.yourlawyer.com/articles/title/yasmin-lawsuit-documents-reveal-bayer-concealed-blood-clot-risks Tue, 06 Dec 2011 00:00:00 -0500 http://www.yourlawyer.com/articles/title/yasmin-lawsuit-documents-reveal-bayer-concealed-blood-clot-risks More documents have been unsealed in the Yaz and Yasmin litigation, including an expert witness report that alleges Bayer AG hid evidence pointing to a higher risk of blood clots among Yasmin users from the U.S. Food & Drug Administration (FDA).  According to a Bloomberg News report, the allegations were made by David Kessler, a former FDA commissioner.

Kessler's statement was one of five expert opinions released yesterday by lawyers representing former users of Bayer’s Yasmin family of contraceptives in thousands of personal injury lawsuits. In his 121-page report, Kessler writes that Bayer had documented in the draft of an August 2004 white paper that Yasmin was 10 times more likely to cause serious side effects including deep vein thrombosis (DVT), a dangerous type of blood clot. But when the paper was submitted to the FDA, the statement mentioning the increased DVT risk was omitted. Also omitted was an earlier draft opinion by company researchers that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” compared with other oral contraceptives, Kessler said.

“Had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin’s NDA (new drug application) could be made,” Kessler wrote.  “These facts would impact the agency’s risk-benefit equation about the drug and whether it could be approved,” Kessler continued.

The FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for December 8 to discuss the safety of newer birth control pills, including Yaz and Yasmin.  Unfortunately, the FDA advisors won't have access to Kessler's report, because the agency refused to accept it for submission.   According to the agency, it wasn't  received prior to the November 23 cut-off date for submissions.

Yaz and Yasmin have been named in more than 10,000 lawsuits alleging Bayer neglected to appropriately warn patients and doctors about increased health risks associated with the drugs.  Thousands of those lawsuits have been consolidated the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100), currently pending before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.  Kessler's report was released by plaintiffs' attorneys involved in the consolidated litigation.
 


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Another Study Points to Yaz, Yasmin Dangers http://www.yourlawyer.com/articles/title/another-study-points-to-yaz-yasmin-dangers Tue, 08 Nov 2011 00:00:00 -0500 http://www.yourlawyer.com/articles/title/another-study-points-to-yaz-yasmin-dangers For the third time in just a few weeks, a study is confirming a higher risk of blood clots among women who use birth control pills like Yaz or Yasmin.  According to the new study, the increased blood clot risk associated with Yaz, Yasmin and other pills made with the progestin, drospirenone, would translate to about eight to 10 clots per 10,000 women per year.

The new study is published in the Canadian Medical Association Journal, and involved more than 300,000 women in Israel, found that women who took pills made with drospirenone, including Yaz or Yasmin, faced a 43 percent to 65 percent higher risk of suffering a type of blood clot called venous thromboembolism (VTE).  According to the article, the VTE risk associated with such birth control pills increased with age.

This new study is just the latest to point to dangers associated with Yaz and Yasmin.  At  the end of last month, the U.S. Food & Drug Administration (FDA) announced that a study it commissioned had found women taking Yaz, Yasmin and other pills made drospirenone had a 75 percent greater chance of experiencing VTE compared to those using pills made with levonorgestrel.   Just prior to the FDA announcement, a separate study published in the British Medical Journal found drospirenone and other new-generation progestins double the risk of blood clots compared to levonorgestrel.

The FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for December 8 to discuss the safety of drospirenone birth control pills.

 

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New Study Provides Strong Evidence of Yaz, Yasmin Blood Clot Danger http://www.yourlawyer.com/articles/title/new-study-provides-strong-evidence-of-yaz-yasmin-blood-clot-danger Wed, 26 Oct 2011 00:00:00 -0400 http://www.yourlawyer.com/articles/title/new-study-provides-strong-evidence-of-yaz-yasmin-blood-clot-danger A new study has confirmed that Yaz, Yasmin and other birth control pills made with the synthetic progestin, drospirenone, are more likely to cause blood clots.  The study, published yesterday in the British Medical Journal, found drospirenone birth control pills double the risk of blood clots compared to those that contain an older progestin, levonorgestrel.

The study found similar increased risks with birth control pills containing two other newer, synthetic progestins, desogestrel and gestodene.

This new study was conducted by researchers at the University of Copenhagen in Denmark, who reviewed data of the hormonal contraception patterns and first time venous thromboembolism (VTE) episodes for all Danish non-pregnant women between the ages of 15 and 49 from January 2001 until December 2009.   Compared with women not using hormonal contraception, the relative risk of suffering a blood clot increased sixfold among women taking birth control pills in women taking drospirenone, gestodene or desogestrel pills.  Among women taking a pill with the progestin levonorgestrel, the risk only increased by threefold.

Yaz, Yasmin and other drospirenone-containing birth control pills have become popular because some women tolerate this type of progestin better, and some side effects, like water retention, are less severe compared to other pills. But drospirenone is known to carry other risks. For one thing, it can impact the body’s potassium levels, which can cause a condition known as hyperkalemia, and lead to serious health complication.

Earlier this year, the U.S. Food & Drug Administration (FDA) decided to review the safety of drospirenone contraceptives after two other British Medical Journal studies reported that pills made with drospirenone increased those risks significantly compared to pills made with levonorgestrel.   In addition to the two British Medical Journal studies, the agency also reviewed preliminary results from a study it funded which showed n approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.

In an update issued last month, the FDA said it has not yet reached a conclusion, but remains concerned, about the blood clot risk that may be posed by birth controls like Yaz and Yasmin that contain drospirenone.  The agency has decided to schedule a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills.


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Yasmin Survivors Administrator, Helena Mathis | Video, Yaz, Ocella, Side Effects http://www.yourlawyer.com/topics/overview/Yasmin-Survivors-Forum-Video Wed, 26 Oct 2011 00:00:00 -0400 http://www.yourlawyer.com/topics/overview/Yasmin-Survivors-Forum-Video Yasmin Survivors Forum Administrator, Helena Mathis

Check out this video about the Yasmin Survivors Forum administrator, Helen Mathis, discuss the forum. Helena Mathis is a Yasmin survivor herself and had suffered adverse side effects from taking the defective drug.

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