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.
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.
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 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.
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 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.
The week of April 10, 2012 marked a week of monumental developments in ongoing litigation over DROSPIRENONE (DRSP) containing birth control pills. FDA announced revisions in the label for the entire brand warning of the potential for 3x higher blood clot risk from use of the pills. The manufacturer, BAYER HEALTHCARE PHARMACEUTICALS, issued related public relations information that diminished the significance of these new and revised warnings after profiting for over a decade from the higher risk oral contraceptives.
APRIL 13, 2012: YAZ, YASMIN, BEYAZ, SAFYRAL & GENERICS TO GET NEW UPGRADED WARNING LABEL - APRIL 2012.
Following the announcement, BLOOMBERG reported on a select number of DROSPIRENONE LAWSUIT, DRSP LAWSUIT, YAZ LAWSUIT OR YAZ CLAIMS settlements discussed here. The settlements involve blood clot and complications from debilitating injuries. The confidential sources cited by BLOOMBERG estimate $110 Million U.S. Dollars in settlements of a minority of pending lawsuits that exceed 11,000.
APRIL 13,2012: DROSPIRENONE (DRSP) SETTLEMENTS-Bayer Said to Pay $110 Million in Yaz Birth-Control Cases - Bloomberg
While the DROSPIRENONE (DRSP) containing family of contraceptives continue for sale, despite FDA’s own study confirming a 74% higher risk of blood clots, the sponsor of this site continues to evaluate potential DROSPIRENONE SETTLEMENTS and YAZ LAWSUITS.
In late July 2012, BAYER announced that it had agreed to settle 1,877 blood clot lawsuits involving DROSPIRENONE (DRSP) containing birth control pills. BLOOMBERG disclosed related information in “BAYER’S YASMIN SETTLEMENTS RISE TO $402.6M“.This includes cases involving personal injuries from Pulmonary Emboli or Deep Vein Thrombosis. Nearly 13,000 lawsuits were filed claiming a variety of injuries and complications from use of the oral contraceptives. As of July 19, 2012, YAZ LAWSUIT SETTLEMENTS reportedly totaled $402 Million U.S. Dollars with total settlements expected to reach exponentially higher figures as catastrophic cases involving death or permanent disability are resolved.
YAZ LAWSUITS SETTLEMENTS JULY 2012 UPDATE.
YAZ SETTLEMENTS UPDATE INFORMATION 2012
FREE DROSPIRENONE SETTLEMENT CASE EVALUATIONS ARE AVAILABLE THROUGH USE OF THE CONTACT FORM BELOW.
With over 11,300 YAZ CLAIMS pending as of February 2012, as discussed here, this is the first report of a meaningful settlement of some blood clot cases. There is no discussion of gallbladder cases despite there being a plethora of these cases among pending lawsuits. The BLOOMBERG story notes that an FDA funded study released in October 2011 found that DRSP (DROSPIRENONE) containing birth control pills were 74% more likely to suffer blood clots in comparison to other pills.
This report comes on the heels of the FDA’s announcement this week that the DRSP (DROSPIRENONE) family of contraceptives would carry a revised warning label warning of increased risks of blood clots that may be up to 3x higher in comparison to other pills. The manufacturer has continued to claim otherwise despite multiple studies emerging since 2009, including the FDA’s own study, that confirm a higher risk. FDA’s revised label was announced this past week and raises questions explored below.
YAZ LAWSUITS or YAZ CLAIMS continue to be evaluated and filed. FREE CASE EVALUATIONS are available through the sponsor of this site.
YAZ Updated Warning Labels (Again) in April 2012 as YAZ CLAIM Settlements Announced.
DRSP (DROSPIRENONE) PILL FAMILY TO GET NEW LABELS PER FDA.
As explained in this announcement, FDA “has completed its review of recent observational studies (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin containing pills”. In October 2011, FDA released results from an FDA-funded study of the blood clot risk and this announcement indicates that “revised drug labels” will include a summary of their results.
What does this mean? Granted the FDA’s announcement couches the revised labels in terms of “may be associated with a higher risk for blood clots” it is clearly a step in the right direction in terms of warning potential users and prescribers of the higher risk of blood clots presented by DROSPIRENONE (DRSP) containing birth control pills. For many girls and women, the warning is too late and they have suffered debilitating injuries or complications from blood clots. Those girls and women are pursuing YAZ CLAIMS or their individual YAZ CLAIM for related injuries given that they were never fully warned of the potential consequences and higher risk the pills presented. Since 2009, the manufacturer has continued to resist scientific findings of increased risk and defend the Blockbuster $1 Billion in Annual sales products associated with DROSPIRENONE (DRSP). However, FDA’s own study noted that the picture was literally becoming clearer with regard to the higher risk these pills pose to users despite the manufacturers defense to the contrary.
Civil Jury Trial remain pending, with settlement discussions ongoing regarding YAZ CLAIMS, FDA’s action may provide a needed catalyst to promote awareness of the risks associated with these pills, outside of the litigation context and claimed defenses of the manufacturer.
FREE YAZ CLAIM EVALUATIONS are available through the sponsor of this site by using the contact form below.
YAZ, YASMIN, BEYAZ, SAFYRAL & GENERICS TO GET NEW UPGRADED WARNING LABEL - APRIL 2012.
YAZ CLAIMS CONTINUE IN 2012 – YAZ CLAIM LAWSUITS UPDATE
April 8, 2012 marks 4 (Four) months to the day that the FDA held Advisory Committee Hearings between joint experts panels to discuss DRSP (DROSPIRENONE) containing birth control pills and findings from FDA’s own study on the subject (as discussed here). The proceedings were arguably plagued by confusion as revealed in the transcripts, and perhaps more disconcerting by alleged “conflicts of interests” asdiscussed here. To date, the FDA has not formally acted, or linked any recent activity to the vote or recommendations of the experts they convened. This fact raises more questions about whether the FDA will act on the two votes entertained that day and if so when?
In February 2012, the FDA approved additional information for inclusion in the safety labeling that accompanies DRSP (DROSPIRENONE) containing birth control pills as illustrated below. Notably, there is no mention whatsoever of FDA’s own study that found the pills present a higher risk of blood clots than other pills. Similarly, the labeling does not reflect FDA’s finding (in their study) that women in the 35-55 age group were at higher risk of Arterial Thromboembolic Events for unexplained reasons. Whether FDA will take stronger action, in light of the experts recommendations and tepid 15-11 vote that allowed the pills to remain on the market remains to be seen.
YAZ CLAIMS UPDATE APRIL 2012 - SAFET LABELS & QUESTIONS.
YAZ CLAIMS, or a YAZ CLAIM, continued to be evaluated and filed as civil lawsuits over blood clot injuries. Awareness of the dangers of DRSP (DROSPIRENONE) birth control pills, in comparison to other pills, has grown since the 1st BMJ study in 2009 explained related findings. However, in the nearly 3 (three) years since the manufacturer has continually disputed other independent studies and fought FDA’s findings by claiming some scientific debate remains or is justified. All the while new users unwittingly embrace the novel progestin and the marketplace has yet to see the proper warnings placed on these pills despite mounting and damning scientific evidence of the risk they present.
FREE YAZ CLAIMS EVALUATIONS are available through the use of the contact form below.
DRSP (DROSPIRENONE) 3mg birth control pill family from BAYER HEALTHCARE.
DRSP (DROSPIRENONE) 3mg birth control pill family from BAYER HEALTHCARE.
YAZ CLAIM or YAZ CLAIMS: DO YOU HAVE ONE?
YAZ CLAIM or YAZ CLAIMS is often used to refer to a potential, or pending, lawsuit involving any of the DRSP (DROSPIRENONE) containing family of birth control pills. As discussed on this site here, the history of these pills has raised a number of “red-flags”, FDA action and safety signals. Their history has now combined with over 11,000 pending lawsuits served on the manufacturer, BAYER HEALTHCARE PHARMACEUTICALS, with no end in site as long the pills remain on the market without adequate warning labels.
If you already have an attorney you should contact your attorney for periodic updates on the status of your YAZ CLAIM or YAZ CLAIMS. If you do not already have an attorney you may seek out a FREE CASE EVALUATION by requesting one. You will not “know” if you have a claim unless you have your potential injury evaluated or screened.
YAZ CLAIMS INVOLVING DEATH, BLOOD CLOTS, STROKES, PULMONARY EMBOLI, DEEP VEIN THROMBOSIS & RELATED COMPLICATIONS
We are actively evaluating and screening cases involving YAZ SIDE EFFECTS that include the following:
Death while using a DRSP (DROSPIRENONE) containing birth control pill;
Strokes;
Pulmonary Emboli (PE);
Deep Vein Thrombosis (DVT);
Arterial Thromboembolic Events (ATE);
Acute Myocardial Infacrtion (AMI);
Heart Attack(s);
Venous Thromboembolism (VTE);
Ischemic Strokes;
Pancreatitis and complications from treatment of pancreatitis.
YAZ CLAIMS INVOLVING GALLBLADDER DYSFUNCTION & SURGERY
A YAZ CLAIM can also involve allegations of gallbladder dysfunction and surgical removal. Any surgery presents potential complications and scarring which are the subject of related YAZ CLAIMS. Gallbladder lawsuits, arising out of use of a DRSP (DROSPIRENONE) containing birth control pill have not gained the widely received publicity the blood clot cases have for a number of reasons. Regardless, claims of gallbladder dysfunction, resulting in surgical removal – cholecystectomy – are being investigated and pursued for girls and women that have used a DRSP (DROPSPIRENONE) containing birth control pill.
FREE CASE EVALUATIONS are available through use of the YAZ CLAIM or YAZ CLAIMS contact form below. The sponsor of this site is Gabriel F. Zambrano, P.A.. Gabriel F. Zambrano, P.A., is actively involved in representing girls and women injured by use of a DRSP (DROSPIRENONE) containing birth control. As a an early advocate about the dangers of these contraceptives he remains an active participant in National litigation regarding these pills which includes cases in a Federal Multi-District Litigation (MDL), as well as coordinated State Court proceedings in Pennsylvania, California and New Jersey.
DRSP (DROSPIRENONE) pills YAZ trademarked by BAYER HEALTHCARE.
FDA SPOTLIGHT ON YAZ CONTINUES 90 DAYS AFTER RECALL VOTE
FDA SPOTLIGHT REMAINS ON YAZ DRSP (DROSPIRENONE) PILLS.
90 DAYS AFTER FDA ADVISORY COMMITTEE VOTE & SETTLEMENT UPDATES
FDA AD COMM VOTE WAS 12.8.11 - ACTION PENDING.
Ninety (90) Days ago, on December 8, 2011, the U.S. Food & Drug Administration, convened a joint panel of experts to discuss emerging studies that linked DRSP (DROSPIRENONE) containing birth control pills to the increased risk of blood clots. Since 2009, multiple studies, including an FDA funded study have reached the very same conclusion: DRSP (DROSPIRENONE) containing birth control pills increase the risk of blood clots exponentially in comparison to other pills. The manufacturer, BAYER HEALTHCARE PHARMACEUTICALS, has repeatedly disputed these findings and pointed to studies, with close ties to them or the industry, for support of their defense.
The December 8, 2011, Advisory Committee voted, 21-5, that the WARNING LABELS communicating risks to users, or consumers, as well as prescribing physicians needed to include findings from FDA’s study, and other independent studies, that were released during October 2011 that show an increased risk of blood clots from use of DRSP (DROSPIRENONE) containing birth control. Only days before FDA released it’s findings an independent study also released in October 2011 once again found DRSP (DROSPIRENONE) containing birth control pills increased the risk of blood clots in comparison to other pills.
11,000 YAZ LAWSUITS PENDING – BAYER’S ANNUAL REPORT
BAYER 2011 ANNUAL REPORT CONFIRMS OVER 11,000 YAZ LAWSUITS.
As of February 1, 2012,11,300 YAZ LAWSUITS alleging personal injuries from use of a DRSP (DROSPIRENONE) containing birth control remain pending. More are anticipated as DRSP (DROSPIRENONE) birth control pills remain on the market with WARNING LABELS already determined to not reflect information and knowledge about the elevated risks of Blood Clots, Strokes, Myocardial Infarcts, Heart Attacks, Pulmonary Emboli, Deep Vein Thrombosis, Arterial Clots and related complications and potential injuries, or death.
BAYER REPORTS 11,000 YAZ LAWSUITS PENDING in 2012.
Civil Jury Trials were scheduled to commence in January 2012 but were delayed by Judges overseeing the litigation in multiple venues to encourage the parties to explore potential settlements or alternative dispute resolution on a case by case basis. While this is arguably a positive development for litigants it has not changed the “business as usual” promotion of DRSP (DROSPIRENONE) pills. The manufacturer has continued to claim that the pills are both safe and effective when used as directed despite the 21-5 vote recommending FDA upgrade or enhance the WARNING LABEL to better communicate risks to users and prescribers.
After over a decade on the U.S. market the DRSP (DROSPIRENONE) family of contraception pills has continued to expand. There are now four trademarked brands: YASMIN, YAZ, BEYAZ and SAFYRAL and multiple generics. Given the experts vote, it can be argued that DRSP (DROSPIRENONE) containing birth control pills have not fully informed users of increased risks for years, or quite possibly from the time they were launched in the U.S. market. Without fully knowing risks associated with a product, how can someone make an informed choice about using the product? This question is one of many at the heart of YAZ LAWSUITS and any pending YAZ SETTLEMENTS.
Recently published reports have pointed to progress in ongoing YAZ SETTLEMENT negotiations with claims of seventy (70) settlements having occurred as of February 13, 2012.
BAYER REPORTS SETTLEMENTS in 2012.
This information and graphic above is taken from BAYER’s ANNUAL REPORT which is available on line.
YAZ RECALL VOTE RAISES CONFLICT OF INTEREST ? 11,000 YAZ LAWSUITS PENDING. FREE CASE EVALUATIONS.
To date, no official FDA action on either the 15-11, or 21-5, vote nor calls by public interest group for a re-vote over the December 8, 2011 hearings. We will update this site with any public reports of information.
FREE YAZ LAWSUIT CASE EVALUATIONS are available from the sponsor of this site.
Gabriel F. Zambrano, P.A., by using the contact forms above or below. Gabriel F. Zambrano, represents several of the 1st 100 Girls and Women to file YAZ LAWSUITS throughout the United States and has been at the forefront of claims regarding DRSP (DROSPIRENONE) containing birth control pills since before 2009.
YAZ LAWSUITS have been ordered to YAZ MEDIATION CONFERENCES, or YAZ SETTLEMENT CONFERENCES in the near future. Civil Jury Trials were expected to begin on a rolling basis in a number of venues over YAZ SIDE EFFECTS and YAZ PERSONAL INJURY LAWSUITS.
YAZ SETTLEMENTS UPDATE:
On January 5, 2012, BLOOMBERG reported on a December 31, 2012, court order that has precipitated YAZ SETTLEMENT discussions. Essentially, the parties to the very first YAZ LAWSUIT set for Trial in 2012, were ordered to participate in ‘good faith’ settlement negotiations with a skilled third party. The BLOOMBERG story by Jef Feeley & Naomi Kresge, “BAYER JUDGE POSTPONES FIRST YAZ TRIAL, ORDERS BIRTH-CONTROL CASES MEDIATED“, provides more background and detail on this subject. Essentially, the Federal Judge in charge of tens of thousands of YAZ LAWSUITS ordered that the parties sit down and have a third party evaluate their respective positions and consider YAZ SETTLEMENT opportunities for interested parties.
What does this mean for girls and women that have been injured from use of a DRSP (DROSPIRENONE) containing birth control? To be considered in any future YAZ SETTLEMENT, they must have their potential YAZ LAWSUIT, or YAZ CLAIMS, evaluated by YAZ ATTORNEYS or YAZ LAWYERS with knowledge of the litigation. These cases have now been going on for over two (2) years and many women have yet to come forward to present, or press, their claims.If you or a loved one have suffered injuries from use of a DRSP (DROSPIRENONE) containing birth control pill you should seek a FREE CASE EVALUATION. YAZ LAWSUITS continue to be filed for girls and women that have suffered injuries from use of the once popular birth control pills, these cases involve injuries or YAZ SIDE EFFECTS. Each State has a time frame within which lawsuits are to be pursued or filed and this is known as a “Statute of Limitations”, or “Statute of Repose”. As such, the time frame is evaluated on a case by case basis based upon facts unique to each girl or woman.
YAZ SETTLEMENTS & MEDIATION ORDERED.
FREE CASE EVALUATIONS for a YAZ LAWSUIT, or claim of YAZ SIDE EFFECTS, are available through the sponsor of this site using the contact forms below. Any girl or woman can seek to have their case evaluated if they believe they have suffered personal injuries from use of a DRSP (DROSPIRENONE) containing birth control pill. Injuries include: Blood Clots, Pulmonary Emboli, Strokes, Deep Vein Thrombosis, Venous Thromboembolism, Cardiac Events, Gallbladder injury or removal, as well as pancreatitis.
