YAZ RECALL UPDATE 2013

YAZ LAWSUITS PENDING – NO YAZ RECALL, YET….

YAZ RECALL UPDATE 2013

YAZ RECALL UPDATE. YAZ RECALL vote by FDA in 2011 still in question.

In December of 2011, an FDA Advisory Committe considered the future of the entire family of DROSPIRENONE (DRSP) containing pills. Embroiled in litigation since 2009, and the subject of multiple independent studies finding higher risks of blood clots, the pills future remains in jeopardy in 2013. Whether the FDA will revisit the future of the pills and enhanced warnings added to the packaging, since the onset of over 13,000 personal injury lawsuits, is open to debate, at least in the United States.

YAZ EUROPE UPDATE 2013

EMA, at behest of France, revisits safety profile of YAZ, YASMIN and other pills, while countries question continued use in Europe.

Emerging reports from Europe have revealed that the European Medicines Agency (EMA), at the behest of France, is re-evaluating the use of DROSPIRENONE (DRSP) containing pills in the European Union. The French initiative coincides with an announcement that the government would not reimburse users of certain pills, including DROSPIRENONE (DRSP) containing pills, because of higher risks of blood clots and complications that essentially burden the health care system. An analysis of related news reports appears here. As noted in this post here, Switzerland’s largest insurer has joined a pending lawsuit to seek reimbursement for medical benefits associated with at least one victim of the new generation of birth control pills.

As noted below, BAYER has continued to evaluate and resolve certain blood clot cases over the course of almost one year. However, thousands of cases remain pending in the United States in 2013. FREE CASE EVALUATIONS and no recovery, no fee contingency fee recoveries remain an option for all victims seeking assistance. The sponsor of this site continues to offer CONFIDENTIAL NO OBLIGATION case evaluations:

 

YAZ LAWSUIT SETTLEMENTS CONTINUE – BAYER CONFIRMS $750M TO DATE

BAYER YAZ LAWSUIT SETTLEMENTS CONTINUE | YAZ LAWSUIT SETTLEMENTS UPDATE OCTOBER 2012

BAYER YAZ LAWSUITS UPDATE OCTOBER 2012

BAYER, the manufacturer of the original DROSPIRENONE (DRSP) containing birth control pills has released information today, October 30, 2012, confirming settlements of blood clot case as of October 15, 2012, totaling $750 Million U.S. Dollars.

YAZ SETTLEMENTS UPDATE OCTOBER 2012

As illustrated above, BAYER has confirmed, and provided the following YAZ SETTLEMENTS UPDATE for OCTOBER 2012:

  • It has agreed to settle approximately 3,490 blood clot cases for a total of $750 Million U.S. Dollars.
  • As of October 15, 2012, the number of related lawsuits pending and served upon BAYER totaled 12,400.
  • Pending unsettled cases include 3,800 blood clot cases.
  • There are an additional 720 cases were claims have been asserted but not filed as lawsuits.
  • Excluding claims already settled there were an additional 13,500 cases filed.
  • Cases are being settled on a case by case basis after a case specific analysis and presentation of medical records on a rolling basis.

Based upon the above, it appears that there are at least another $800 Million U.S. Dollars in blood clot settlements, or YAZ SETTLEMENTS, pending in the 3,800 cases identified as unsettled. Other types of cases remain pending and potentially viable despite the manufacturer not agreeing to consider their settlement as of this writing.

As note below, a number of studies have been published since 2009 that confirm that DROSPIRENONE (DRSP) containing birth control pills present higher risks of blood clots to users. The higher risks and failure to warn were at the heart of related blood clot lawsuits for injuries and complications from Deep Vein Thrombosis or Pulmonary Emboli that became known as YAZ SIDE EFFECTS.

FREE CASE EVALUATIONS remain available through the sponsor of this site by submission of the contact form below. This is a no obligation evaluation of your YAZ BLOOD CLOT CLAIM.

 

YAZ BLOOD CLOT RISK HIGHER – PROVEN AGAIN

YAZ, YASMIN, BEYAZ & SAFYRAL SIDE EFFECTS | HIGHER RISKS

A study published in CONTRACEPTION, “Recent Combined Hormonal Cotnraceptives (CHCs) and the Risk of Thromboembolism and Other Cardiovascular Events in New Users“, confirms disturbing information about DROSPIRENONE (DRSP) containing birth control pills.

DROSPIRENONE (DRSP) PILLS ARE HIGHER RISK PILLS - CONFIRMED AGAIN.

This recent study in one of several, including an FDA funded study, that have reached similar conclusions regarding DROSPIRENONE (DRSP) containing birth control pills. In evaluating the risk of a venous thromboembolic event (VTE), including Pulmonary Emboli (PE) (blood clots in the lungs) or Deep Vein Thrombosis (DVT) (blood clots in the legs) the latest study specifically found the following:

  • We found that the intiation of new use of DRSP-containing” pills was “associated with a 77% increase in the risk of hospitialization for a VTE relative to the use of” a comparable group of four low-dose estrogen pills.
  • “[T]he growing number of studies showing an increased risk of VTE with DRSP suggests that DRSP-containing” pills “should be used cautiously for women seeking hormonal contraception“.

Given there have now been multiple studies showing increased risk of blood clots, from use of a DROSPIRENONE (DRSP) containing birth control pill, one has to wonder why any girl, woman or her prescriber would knowingly choose a DROSPIRENONE (DRSP) containing birth control pill. The history of these pills has marked by FDA WARNING LETTERS, “corrective advertising” necessitated by the manufacturer overstating the alleged benefits of the pills and over 13,000 lawsuits claiming personal injury from use of the pills or their generics.

DROSPIRENONE PILLS ARE HIGHER RISK PILLS PER STUDIES.

DRSP (DROSPIRENONE) PILL FAMILY PRESENTS HIGHER RISKS OF BLOOD CLOTS.

Disturbingly, the significance of the troubled history, ongoing litigation, near market withdrawal, or recall, in December 2011, is lost among many people. Apparently, even The American College of Obstetricians & Gynecologists (ACOG) has a short lived memory and self serving interpretation of the latest study as illustrated below.

ACOG FAILS TO PROPERLY WARN OF DROSPIRENONE (DRSP) RISKS.

ACOG FAILS TO WARN OR DROSPIRENONE (DRSP) RISKS.

No girl or woman can have a free, or educated choice, in their contraceptive decision if they are not adequately or properly informed. The failure of the manufacturer to adequately warn of risks associated with DROSPIRENONE (DRSP) containing birth control pills resulted in over 13,000 lawsuits, as well as label changes and a near recall of the pills in December 2011. The Devil is in the Details as the illustration above indicates but ACOG has arguably forgotten many details associated with DROSPIRENONE (DRSP) containing birth control pills.

FREE YAZ LAWSUIT CASE EVALUATIONS ARE AVAILABLE THROUGH USE OF THE CONTACT FORM BELOW.

 

 

 

BEYAZ BIRTH CONTROL REVIEWS: BEYAZ VS. YAZ UPDATE – SEPTEMBER 2012

BEYAZ BIRTH CONTROL REVIEW: BEYAZ VS. YAZ SIDE EFFECTS

BEYAZ® BIRTH CONTROL - PILLS LINKED TO BLOOD CLOTS 2012.

DROSPIRENONE (DRSP) containing birth control pills have received considerable scrutiny since August 2009. This scrutiny is deserved given that multiple studies have shown the novel progestin, that was touted as making the pills better and marketed with implied scientific superiority, presents a higher risk of blood clots to users. Unfortunately, nearly 13,000 lawsuits and multiple independent studies have done little to draw attention to the same, and potentially identicial, dangers of the trademarked cousin BEYAZ.

A study released by the U.S. Food & Drug Administration (FDA) in late October 2011 arguably found cause for alarm and confirmed prior studies. To date only studies paid for in some way, or somehow associated with the manufacturer, have found no added risk in DROSPIRENONE (DRSP) containing birth control pills. Multiple independent studies have all raised questions about the safety profile of the pills. An FDA hearing, on December 12, 2012, of a joint panel of experts almost recalled the pills and that process was questioned because a number of panel members had ties to the manufacturer that were not fully disclosed until after the controversial vote that led to a label change and near recall.

BEYAZ was approved for use by the U.S. Food & Drug Administration (FDA), in the midst of ongoing lawsuits and forthcoming studies of DROSPIRENONE (DRSP). BEYAZ is promoted as being a hormonal contraceptive that offers the same benefits of YAZ with
the added benefit of raising folate levels. In other words, it provides vitamin supplementation intended to reduce the chances of a rare birth defect, spina bifida, for users concerned that their pill will fail or intent on attempting to become pregnant shortly after they stop using BEYAZ.

In July 2012, the Department of Health & Human Services, Public Health Service, Food & Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, released a “Pediatric Postmarket Adverse Event Review” that considered the use of BEYAZ in pediatric patients (ages 0-17). The public release of this “report” received little press or attention in circles outside the YAZ litigation.
Sadly, this report confirmed that there are no epidemiologic studies evaluating the safety of BEYAZ specifically. As a a result, by default, to consider the safety of BEYAZ prescribers, patients and consumers are left to consider the alarming studies that have become part of the label and warning, as well as the double talk approved by the FDA contained in those ‘warnings’. A link to the “Pediatric Postmarket Adverse Event Review“ is available here.

In the end, any potential patient, consumer or prescriber must make up their own mind about using BEYAZ knowing that little is truly known about the pill despite years of litigation and the original DROSPIRENONE (DRSP) containing birth control pill having
been available know for over a decade. Does that make you feel good about such a choice?

BEYAZ BLOOD CLOT CASE EVALUATIONS ARE AVAILABLE THROUGH USE OF THE CONTACT FORM BELOW FROM THE SPONSOR OF THIS SITE.

BAYER ANNOUNCES $402M IN DROSPIRENONE SETTLEMENTS UPDATE – JULY 2012

YAZ SETTLEMENTS UPDATE INFORMATION 2012

YAZ LAWSUITS SETTLEMENTS UPDATE – JULY 2012

YAZ LAWSUITS SETTLEMENTS UPDATE

In a recently released publication, BAYER has confirmed that as of July 19, 2012, it had agreed in principle to settle approximately 1,877 blood clot cases. As a result, it reported $402M in settlements had been reached in the pending litigation. These cases involve blood clots, which include Pulmonary Emboli, Deep Vein Thrombosis and related complications. This report is a follow up to prior reports of ongoing settlement negotiations.

Reported settlements do not translate into payments or money having exchanged hands as of this time. Rather, these are agreements to resolve cases, on a case by case basis following extensive litigation, commenced in 2009, and the evaluation of claimed injuries. The parties have been engaged in meaningful settlement negotiations – as reported below – since January 2012. Cases involving gallbladder removal or surgery are not considered part of these settlements as indicated in the insert above.

FREE CASE EVALUATIONS ARE AVAILABLE THROUGH USE OF THE CONTACT FORM BELOW.

NEJM STUDY FINDS HIGHER RISKS LINKED TO YAZ, YASMIN, BEYAZ & SAFYRAL TYPE PILLS

NEJM STUDY FINDS RISK OF THROMBOTIC STROKE & MYOCARDIAL INFARCTION WITH HORMONAL PILLS CONTAINING EE ESTROGEN IN YAZ,YASMIN, BEYAZ & SAFYRAL PILLS

NEW NEJM STUDY FINDS STROKE & HEART ATTACK RISK LINKED TO ESTROGEN IN YAZ, YASMIN, BEYAZ & SAFYRAL.

In “THROMBOTIC STROKE AND MYOCARDIAL INFARCTION WITH HORMONAL CONTRACEPTION“, an Abstract in the prestigious New England Journal of Medicine (NEJM) evaluates 15 years of data to address the risk of thrombotic stroke and heart attacks, or myocardial infarction, in birth control pills that contain ETHINYL ESTRADIOL (EE) as an estrogen. Until now, most of the focus and risks associated with the trademarked YASMIN, YAZ, BEYAZ & SAFYRAL pills centered on their containing the protesting DROSPIRENONE (DRSP). As noted in other posts, independent studies, and an FDA funded study have confirmed they present a higher risk of blood clots in comparison to other pills. This “new” study followed women from the ages of 15-49 with no  prior history of heart disease or cancer. The data analyzed involved 1.6 Million women and compared certain types of available hormonal contraceptives and the risks associated with the for thrombotic strokes and heart attacks. The authors concluded that there was a link between those pills that contain .02 micrograms of ETHINYL ESTRADIOL (EE), as well as those that varied from .03 micrograms to .04 micrograms. The risk was increased by a factor of 0.9-1.7 in those with .02 micrograms and 1.3-2.3 for those with .03-.04 micrograms of ETHINYL ESTRADIOL (EE). The only difference between YASMIN & YAZ is the difference in the amount of ETHINYL ESTRADIOL, as well as the length of dosing. Similarly, the difference between BEYAZ & SAFYRAL is the addition of folate. Basically, all DROSPIRENONE (DRSP) containing birth control pills fall within either of these higher risk ranges. The point is not how low the probability of an adverse event is, but whether or not consumers are being properly warned by the manufacturer before they choose their pills.

What does this add to the risks associated with the use of a DROSPIRENONE (DRSP) containing birth control? Another factor for all prescribers, girls, their Mothers and adult women to consider when choosing their hormonal contraceptive. Why would any DROSPIRENONE (DRSP) birth control pill be the 1st choice for any 1st time user, or why would any woman switch from an established hormonal contraceptive to a DROSPIRENONE (DRSP) containing birth control pill if they are properly and adequately informed of available data and risks? Arguably, they would not.

Unfortunately, many girls, their Mothers, adult women and their prescribers did not know any better prior to 2009. Mounting evidence appears to confirm that DROSPIRENONE (DRSP) containing birth control pills present higher risks that outweigh their effectiveness and that the FDA or manufacturer should consider a market withdrawal or recall.

FREE CASE EVALAUTIONS are available through use of the contact form below from the sponsor of this site. We will evaluate and consider cases from the time that DROSPIRENONE (DRSP) containing birth controls pills, and their generic equivalents were launched until such time that they are ultimately recalled, if ever.

DRSP (DROSPIRENONE) PILL FAMILY TO GET NEW LABELS PER FDA.

 

 

YAZ YASMIN LINKED TO IRRITABLE BOWEL SYNDROME

YAZ YAS LINKED TO IRRITABLE BOWEL SYNDROME (IBS) IN NEW STUDY

A recently released, but little publicized study, has confirmed a direct link between the use of  DROSPIRENONE (DRSP) containing birth control pills and the diagnosis of IBS or Irritable Bowel Syndrome. Such pills include the trademarked YASMIN, YAZ, BEYAZ and SAFYRAL pills marketed by BAYER HEALTHCARE PHARMACEUTICALS that have already been linked to increased risks of blood clots and related complications.

DROSPIRENONE (DRSP) BIRTH CONTROL USE LINKED TO ISB DIAGNOSIS.

The common denominator between all DROSPIRENONE (DRSP) containing birth control pills is 3 mg of the novel progestin developed by BAYER’s predecessor BERLEX. With nearly 12,000 personal injury lawsuits pending as of April 2012, it has been known that a large majority of the lawsuits involve young healthy girls and women claiming gallbladder injuries, dysfunction, removal and related complications. The new study may undermine  skeptics that believe the gallbladder cases were not compensable injuries given the only settlement discussion to date have focused upon blood clots. Rough estimates identify between 60%-70% of pending cases as having a gallbladder link.

In “Irritable Bowl Syndrome and Drospirenone Containing Oral Contraceptives: A Comparative Study“, ST Bird, W Liu, JM Brophy, JA Delaney and M Eminan, note that DROSPIRENONE (DRSP) is an antimineralcorticoid and man made analog of spironolcatone. Because of a known association between spironolactone and the increase risk of gastrointestinal bleeding it is believed the properties of these drugs could irritate the gastrointestinal tract and lead to symptoms of IBS or Irritable Bowel Syndrome. The study included nearly 1 Million women and compared users of DROSPIRENONE (DRSP) birth control pills with users of another hormonal contraceptive pill LEVONORGESTREL. The study found a link between DROSPIRENONE (DRSP) use and a diagnosis of IBS, Irritable Bowel Syndrom, that was not observed by the authors with other oral contraceptives.

It is simply to early to tell what impact, if any, this study will play on the pending gallbladder cases or cases involving pancreatitis. Regardless, any association between DROSPIRENONE (DRSP) containing birth control pills and yet another side effect, or higher risk of side effect, that was not warned about raises more questions about why these pills remain on the market.

FREE CASE EVALUATIONS are available through use of the contact form below.

 

 

 

 

DROSPIRENONE RISKS AS HIGH AS NUVARING VAGINAL RING, OR HIGHER?

NUVARING VAGINAL RING RISK OF BLOOD CLOTS COMPARABLE TO YASMIN, YAZ, BEYAZ, SAFYRAL, OCELLA, GIANVI AND DROSPIRENONE (DRSP) CONTAINING PILLS

MAY 2012 BMJ STUDY COMPARES NUVARING VAGINAL RING RISKS TO DROSPIRENONE (DRSP) CONTAINING PILLS: YASMIN, YAZ, SAFYRAL,BEYAZ, OCELLA, GIANVI & GENERIC EQUIVALENTS.

Only a month after the FDA announced that DROSPIRENONE (DRSP) containing birth control pills would carry new warnings – alerting prescribers and consumers for the 1st time – that the entire line of pills carried a higher risk of blood clots the once ubiquitous birth control pills are again being compared to a high risk product – the trademarked NUVARING or VAGINAL RING. On May 10, 2012, the BRITISH MEDICAL JOURNAL (BMJ), released the study depicted above, which contained the following findings:

  • NUVARING use, or the VAGINAL RING, conferred a 90% higher risk of blood clots (venous thrombosis) than oral contraceptives containing levonorgestrel. This finding meant the risks was comparable to that of DROSPIRENONE (DRSP) containing birth control pills including the trademarked: YASMIN, YAZ, BEYAZ & SAFYRAL which may be the highest risk pills on the market. As discussed on this site, the pills narrowly escaped a recall in December 2011.
  • NUVARING VAGINAL RINGS presented a 48% higher risk of blood clots (venous thrombosis) in comparison to users of levonorgestrel contraceptives in a FDA study released during October 2011.
  • Compared with non-users of hormonal contraceptives, the relative risk of confirmed venous thrombosis (blood clots) in users of the vaginal ring was 6.5 (4.7-8.9) higher.
The study was published days before “National Women’s Health Week” but gained little attention or traction. Should this have been big news? Arguably, yes because it presented an opportunity for public health authorities and the news media to alert girls, women and prescribers to a growing pattern linking two of the ‘newest’ forms of birth control to higher risks that could prove fatal.

NUVARING VAGINAL RINGS LINKED TO HIGH RISK OF BLOOD CLOTS AND COMPARED TO YASMIN, YAZ, BEYAZ, SAFYRAL, GIANVI & OCELLA.

The fate of both contraceptives have been linked together since the FDA funded a study to evaluate the risks of these products and transdermal patches. In October 2011, FDA noted that the finding of increased risk of blood clots from NUVARING VAGINAL RINGS relative to other hormonal contraceptives was a ‘new’ finding and raised concerns that needed to be replicated in other studies. The BMJ’s release of a new study underscores a risk already highlighted by the FDA. NUVARING VAGINAL RINGS and DROSPIRENONE (DRSP) containing birth control pills present higher risk of blood clots to users than other available forms of birth control. Both remain on the market and are the subject of ongoing lawsuits over personal injuries. Additional information on VAGINAL RING LAWSUITS is available at this site dedicated to VAGINAL RING LAWSUITS.

CASE EVALUATIONS FOR GIRLS OR WOMEN THAT SUFFERED A BLOOD CLOT FROM USE OF A NUVARING VAGINAL RING OR DROSPIRENONE (DRSP) CONTAINING BIRTH CONTROL PILL ARE AVAILABLE FROM THE SPONSOR OF THIS SITE THROUGH THE CONTACT FORM BELOW. YOU WILL BE CONTACTED WITHIN 18 HOURS OF YOUR E-MAIL REQUEST. ADDITIONAL INFORMATION REGARDING VAGINAL RING LAWSUITS IS AVAILABLE HERE.

 

FDA MEDWATCH UPDATE 2012:YAZ,YASMIN,BEYAZ,SAFYRAL PILLS

FDA’s MEDWATCH UPDATE APRIL 2012 ON YASMIN, YAZ, BEYAZ, SAFYRAL, GIANVI, OCELLA AND OTHER DROSPIRENONE (DRSP) CONTAINING BIRTH CONTROL PILLS AND GENERIC VARIATIONS 

FDA MEDWATCH SAFETY ALERT APRIL 2012.

During April 2012, the FDA announced that all DROSPIRENONE (DRSP) containing birth control pills would carry and new upgraded warning of increased risks of blood clots. (Discussed here) In “FDA’S MEDWATCH SAFETY ALERTS: APRIL 2012“, represented above, provides as summary of FDA action and alerts during April 2012 here. The text raises questions and arguably “waters down” what the FDA announced on April 10, 2012. Since 2009 multiple independent studies have concluded that DROSPIRENONE (DRSP) containing birth control pills present higher risks to users than comparable pills. In October 2011, FDA released findings of an FDA funded study that also found the pills presented higher risks – 75% higher risk in comparison to other pills – and unexplained risks in the 35-55 age group of Arterial Thromoembolic Events. However, the MEDWATCH ALERT UPDATE FOR 2012 makes no mention of FDA’s own study. Why?

FDA's Consumer Update on MEDWATCH SAFETY ALERT APRIL 2012.

Sadly, this is another missed opportunity for the FDA to raise awareness of the risks of DROSPIRENONE (DRSP) containing birth control pills but they have failed to seize it and make a difference. Ironically, it is National Women’s Health Week this week and the upgraded warnings on the family of pills are barely a month old. Reports of monetary settlements have overshadowed, to some extent, the fact that after over a decade on the market, DROSPIRENONE (DRSP) containing birth control pills will now carry another revised warning over blood clot risks. The arguably troubled history of the pills is outlined here. In the end, with little attention having been brought to recent FDA action on the pills a new post-April 2012 Generation of DROSPIRENONE (DRSP) containing birth control users remains at risk.

We are continuing to evaluated potential blood clot cases from the use of any DROSPIRENONE (DRSP) containing birth control pill. FREE CASE EVALUATIONS are available through use of the contact form below.

YAZ YASMIN SETTLEMENTS CLIMB OVER DROSPIRENONE (DRSP) BLOOD CLOTS

BLOOMBERG REPORTS: BAYER YASMIN YAZ BEYAZ SAFYRAL SETTLEMENTS CLIMB OVER $142 MILLION OVER BLOOD CLOT LAWSUITS INVOLVING BIRTH CONTROL

Bayer YAZ Yasmin BEYAZ SAFYRAL Lawsuit Settlements Climb to $142 Million - Bloomberg

Today, April 26, 2012, BLOOMBERG provided an update on the ongoing YAZ LAWSUITS involving DRSP (DROSPIRENONE) containing birth control pills. In, “BAYER YASMIN LAWSUIT SETTLEMENTS CLIMB TO $142 MILLION“, reporters Jef Feely & Margaret Cronin Fisk, cite to Financial Reports, and BAYER’s Stockholders Newsletter for the First Quarter of 2012, in identifying settlements totaling $142 Million U.S. Dollars. Previously, BLOOMBERG had reported settlements of $110 Million U.S. Dollars only 13 days ago.

DROSPIRENONE birth control confirmed higher risk pills per FDA.

FDA study confirms DROSPIRENONE pills higher risk.

This news comes only 15 days after the FDA announced that the entire family of DRSP (DROSPIRENONE) containing birth control pills would be required to carry a revised label warning users and prescribers of the potential for increased risk of blood clots. Estimates vary on the increased risk from 3x more likely in comparison to other pills or 74% higher risk in comparison as confirmed in an FDA funded study. The contraceptives narrowly escaped a market withdrawal or “recall” on December 8, 2012 in a 15-11 vote of experts.

According to this news report, “Bayer is only settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) after a case specific analysis of medical records“. This report also cites to nearly 12, 000 lawsuits pending the United States court system for girls or women seeking compensation from use of a DRSP (DROSPIRENONE) contraceptive.

FREE YAZ LAWSUIT CASE EVALUATIONS ARE AVAILABLE FROM THE SPONSOR OF THIS SITE.

 

DROSPIRENONE DRSP LAWSUIT SETTLEMENTS REPORTED APRIL 2012