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.
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.
12.8.11 has been circled in the calendars of DRSP (DROSPIRENONE) survivors, watchdog groups, advocates on behalf girls and women that suffered YAZ BLOOD CLOTS or YAZ SIDE EFFECTS, because this day marks the meeting of two expert panels expected to evaluate the increased risk of blood clots and emerging scientific evidence that examine this risk.
BMJ studies repeatedly confirm increased blood clot risk of DRSP since 2009.
In May 2011, the European Medicines Agency (EMA) announced that it was requiring an updated label for DRSP (DROSPIRENONE) containing birth control pills. The EMA did not have the benefit of FDA’s study, which found an elevated risk of 75%, or 1.74x, in comparison to other hormonal contraceptives. FDA’s study was publicly released in late October 2011. Most recently, on December 5, 2011, HEALTH CANADA, announced that it had concluded a “safety review” of medical literature and concluded, consistent with prior studies, that DRSP (DROSPIRENONE) birth control pills present a 1.5x -3.0x risk of blood clots.
FDA is reportedly weighing stricter, or stronger, warning labels on DRSP (DROSPIRENONE) containing birth control pills as reported by REUTERS in “FDA Eyes Stronger Warning on Popular Birth Control” by Alina Selyuk.
Will simply adding additional verbiage to the fine print change the status quo or really impact the behavior of prescribers or consumers of these pills? The label has already been changed twice in the past 18 months, however the initial change literally challenged the results of studies in the context of the printed label and fine print, that have now arguably been embraced by FDA, EMA and HEALTH CANADA. From 2009 through the present, the manufacturer, BAYER HEALTHCARE PHARMACEUTICALS, continues to dispute new science, challenge methodologies and cry ‘error’ to oppose mounting scrutiny. Are the FDA, EMA, HEALTH CANADA all wrong in their similar interpretations of recent studies? Given the conflicting messaging from the manufacturer to FDA, prescribers and consumers how can FDA counter balance a decade of conditioning through television advertising, social media and internet campaigns, promoting DRSP (DROSPIRENONE) as scientifically superior and beneficial? The message that has reached the average person has consistently touted the benefits of these pills, cloaked with FDA’s stamp of approval, called critics, as well as victims of personal injuries, into question through the clever use of statistics and the convenient ability to claim recent science is inadequate or flawed.
FDA WARNING LETTER on Current Good Manufacturing Practices.
Or, does the FDA need to weigh all options and consider stronger action? Recent reports quoting former FDA Commissioner David Kessler raise red flags that indicate FDA will not consider relevant, important and potential outcome altering information during these hearings. What difference that information would have will not be known. Yet, the history of DRSP (DROSPIRENONE) from 2000-2011is now a matter of record. FDA has issued multiple FDA WARNING LETTERS, SAFETY COMMUNICATIONS, cited the manufacturing facility for failure to follow current good manufacturing processes (CGMP), monitored a little publicized recall for the failure to follow CGMP, overseen the need for ‘corrective advertising’, approved two label changes in less than a 14 month period and now had to convene a joint meeting of committees to engage in further debate over the higher blood clot risk DRSP (DROSPIRENONE) containing birth control pills present to consumers under the FDA’s seal of approval.
FDA WARNING LETTER - October 2008 on YAZ
The time for FDA to silence the conflicting message fostered by claims of debatable conclusions, or flawed methodologies, has come. The past decade illustrates the need to consider a YAZ RECALL or implementation of warnings that significantly curtail, or limit the use of DRSP (DROSPIRENONE) containing birth control pills. FDA’s study arguably supports the idea that no DRSP (DROSPIRENONE) birth control pill should be any girl or woman’s first choice when they choose a form of hormonal birth control. As a result, few if any young women, based upon available science, should consider any DRSP (DROSPIRENONE) pill as their initiation into the use of hormonal birth control. Similarly, women that are in between different types of pills need to carefully consider, and be properly warned, about risks associated with their age before considering DRSP (DROSPIRENONE) containing birth control pills. This is consistent with the findings in FDA’s own study prior to any debate or hearings on the subject. In the end, the potential group of consumers for which a DRSP (DROSPIRENONE) containing birth control pill is appropriate appears to be very limited. Studies indicate all hormonal contraceptives have some benefit in treating acne and thus these pills have not been proven to be superior. With regard to any claimed benefit for PMDD, the initial studies were short term and there should now be 10 years, or more, worth of studies to prove whether they are effective or superior to other recognized methods for treating PMDD. Again, there appears to be little proof that PMDD should be treated, either initially, or exclusively, with a DRSP (DROSPIRENONE) containing birth control pill.
DRSP (DROSPIRENONE) pills - Bayer HealthCare AG
As a result, in the final analysis, DRSP (DROSPIRENONE) birth control pills are arguably not safer or more effective in any FDA approved category or indication. If so, what role do the pills have in being an option to girls or women seeking a form of hormonal birth control after 12.8.11? Whether the advisory committee meetings will result in additional and continued ‘evolving warnings’ on DRSP (DROSPIRENONE) containing birth control or other action remains to be seen. We will monitor and report on any developments as they are disclosed or reported.
FDA has released, and posted, briefing documents relating to the 12.8.11 joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. These documents provide a some insight into the anticipated dialogue and discourse the hearings are expected to generate. The FDA released the documents on 12.6.11 and they are available at http://www.fda.gov/
“By failing to disclose all thromboembolic event risk information and marketing YAZ and YASMIN off-label, BAYER needlessly explosed large numbers of women to risks of serious or fatal thromboembolic events“.
“In my opinion, BAYER had a duty to present a full and balanced view of all the data and analysis concerning YASMIN to the FDA and healthcare professionals and failed to do so“.
“It appears, based on the information that I have reviewed, and it is my opinion, that BAYER presented a selective view of the data, and that presentation obscured the potential risks associated with YASMIN“.
“BAYER engaged in extensive, systematic off-label promotion of YASMIN and YAZ for PMS, in violation of FDA law and regulations, thereby unnecessarily exposing large numbers of women to risk of thrombembolic events in violation of state law duties“.
In the face of new science, FDA hearings and emerging scientific evidence, BAYER continues to rely upon prior studies to defend the safety and effectiveness of the DRSP (DROSPIRENONE) family of birth control. Despite mutiple studies, since 2009, as well as FDA’s own study that concluded the pills present a higher blood clot risk than other available hormonal contraceptives, BAYER continues to claim the new studies are flawed or unreliable, thus giving rise for current scientific debate and evaluation.
Regardless of the statistical likelihood of a girl or woman experiencing a blood clot noone should look past the statements of former FDA Commissioner Kessler and his evaluation of confidential and proprietary documents. Girls and women that have taken any DRSP (DROSPIRENONE) pill, YASMIN, YAZ, BEYAZ, SAFYRAL and their generics, have to consider whether or not they were adequately informed at the time of potential risks. The pills have now been available for nearly a decade and the warning labels have only been updated to reflect increased warnings in the past 18 months. FDA hearings may only result in yet another modification to the warning. What does that do for the Generation of Women that took the pills and suffered injuries over the past decade? What does that do for women, or girls, that were injured and did not find lawyers prior to 2009 when studies began to emerge calling the manufacturer’s labeling into question? What does it do for those who have sought legal representation and been told the “Statute of Limitations“, “Statute of Repose” or legal time frame within which to seek a legal remedy has expired?
Kessler’s statements substantiate that they were knowingly exposed to risks, regardless of whether the suffered any harm. Similarly, medical providers have to also question the information that was disclosed to them to aid in making informed decisions with patients. Based upon the legacy DRSP (DROSPIRENONE) pills have already left in the past decade, what future, if any the pills have after 12.8.11 remains to be seen. We will report and monitor on any developments following the hearings. You may contact the sponsor of this site with any questions, or if you have suffered injuries from DRSP (DROSPIRENONE) for a FREE CASE EVALUATION. The sponsor of this site is:
Gabriel F. Zambrano Gabriel F. Zambrano, P.A. 1900 N.W. Corporate Boulevard Suite 450 – West Boca Raton, FL 33431
As noted in prior posts, FDA has scheduled a public hearing of two (2) joint panels of experts to discuss industry backed studies and emerging scientific literature, including an FDA funded study, that confirm an increase risk of blood clots from birth control pills containing DRSP (DROSPIRENONE). FDA’s analysis of related data confirmed a significantly higher risk of potentially life threatening blood clots, or venous thromboembolism (VTE) which can manifest themselves as pulmonary emboli (PE) in the lungs, or deep vein thrombosis (DVT) in the legs.
However, given that FDA’s own studies confirmed a significantly higher risk of blood clots in comparison to other pills, as well as multiple FDA WARNING LETTERS, a prior YAZ RECALL and label changes in April 2010 , it is possible that a past history of action and violations will lead to some assertive action by FDA. While women are undertaking some risk in choosing any form of birth control, to accept any risk they must be fully and adequately informed before they can evaluate the safety and effectiveness of any given product. Historically, the DRSP (DROSPIRENONE) family of birth control focused on hype, which resulted in Four (4) FDA WARNING LETTERS, corrective advertising, a failed inspection of manufacturing facilities and notable deficiencies in good current manufacturing practices, before the April 2010 change in the label. Only after achieving and maintaining a Blockbuster status – over $1Billion in annual sales – did information begin to emerge about the higher risk of blood clots from these pills. Could there be more victims, or survivors of DRSP (DROSPIRENONE) than those 10,000 that have come forward and filed lawsuits? Most likely, yes and time will tell whether they will come forward and connect the dots that have taken so long to materialize since these pills came to market.
With lawsuits already pending against BAYER HEALTHCARE PHARMACEUTICALS for the YAZ family of birth control pills expected to already exceed 10,000, a history of recent FDA safety alerts follows below.
BAYER acknowledges service of lawsuits as of July 2011.
On October 27, 2011,FDA issued yet another alert regarding DROSPIRENONE (DRSP) containing birth control pills that includes YASMIN, YAZ, the more recently approved BEYAZ and SAFYRAL, as well as the generic equivalents of the former. This particular notice alerted healthcare professionals and the public at large of the release of the Final Report of FDA funded study that evaluated the risk of blood clots in users of hormonal contraceptives. The study itself found a significantly higher risk of venous thromboembolism, (VTE), or blood clot from use of DROSPIRENONE (DRSP) containing pills in comparison to other hormonal contraceptives. FDA’s study identified a 1.74x increased risk of blood clots in comparison to other popular hormonal contraceptives.
A month earlier, on September 26, 2011, FDA had noted it ‘remained concerned‘ about the potential increased risk of blood clots from the YASMIN, YAZ family of DROSPIRENONE (DRSP) pills. At the time, it noted a 1.5x increase in the risk of blood clots for users. FDA scheduled 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 risks and benefits, as well as the risk of blood clots, during a public hearing. FDA noted six (6) published studies evaluating this risk, and their own funded study, had come to conflicting findings that it hoped could be addressed or reconciled.
Previously, on May 31, 2011, FDA had issued a public communication noting that two (2) recently published studies evaluating the risk of blood clots and use of DROSPIRENONE (DRSP) pills found an increased risk up to 2x to 3x greater than other pills. FDA reported that it was evaluating conflicting results of studies, would be looking at available information and provided updated communications.
The most recent events above set the stage for a public debate of the safety and effectiveness of YASMIN, YAZ, BEYAZ, SAFYRAL, and their generic equivalents. What risks they present to users, any benefits from use and whether they are worth the risk, are all expected to be discussed during the 12.8.11 meeting of experts noted above. One potential outcome is a market withdrawal, or recall, of these products as discussed by author Jim Edwards in “WILL FDA YANK BAYER’S RISKY BIRTH CONTROL PILL YAZ?“. This article considered a YAZ RECALL a month prior to the latest FDA SAFETY COMMUNICATION and the release of yet three (3) studies relating to the risk of blood clots and these pills (FDA funded study, BMJ and CMAJ). This author has covered the “YAZ story” for a number of years and succinctly note that “With the evidence showing that YAZ carries risks that equivalent drugs do not, FDA will have to ask whether it is justified in allowing it to remain on the market.”
We will update this post, or provide an update, as information is released by FDA or other sources regarding any “YAZ RECALL” and the future of DROSPIRENONE (DRSP) containing birth control.
