Canada’s, The Globe and Mail, is reporting that Health Canada had to ask BAYER to change labels on the YASMIN & YAZ, #DRSP (#DROSPIRENONE) containing, birth control pills. In “YASMIN, YAZ Birth Control Pills May Raise Blood Clot Risk: Health Canada”, H. Branswell reports on yesterday’s (12.5.11) statement from HEALTH CANADA announcing the conclusion of a related ‘safety review’ and finding 1.5x-3.0x increased risk of blood clots for women that use a #DRSP (#DROSPIRENONE) birth control when compared to other pills.
(Prior posts on the HEALTH CANADA announcement appear here.)
Claiming the subject remains open to debate, BAYER is quoted, through Dr. Shurjeel Choudri, as continuing to claim that their own studies demonstrate the clot risk for the pills is in line with other oral contraceptives. This story also quotes BAYER as claiming that “significant methodological issues…that raise important questions about the validity of the conclusions drawn by the authors” exist.
Does this claim of an open scientific debate sound familiar? If you are old enough to remember how Tobacco continued to deny claims that nicotine was linked to cancer, or had addictive qualities, you are familiar with how companies may claim their own studies, or studies they sponsored, present talking points upon which to refute claims regarding a product. Tobacco undertook this defense into the beginning of this Millennium.
FDA is set to hold hearings on 12.8.11 to evaluate conflicting data and emerging science, as well as literature on the increased risk of blood clots these pills pose to users. FDA’s own study found a significantly higher risk of blood clots in comparison to other birth control pills. There have been several studies published, since 2009, in the British Medical Journal (BMJ) that have consistently found the pills to present a higher risk of blood clots. In May 2011, the European Medicines Agency, (EMA) noted in a Monthly Report, Issue Number 1105, that #DRSP (#DROSPIRENONE) containing pills have been shown, in studies, to present a higher risk of blood clots than other pills. At the time, it was recommended that product information for all DRSP (DROSPIRENONE) containing pills be updated to reflect this as fact.
In the US, the DRSP (DROSPIRENONE) family of birth control pills have had a history that involves several FDA WARNING LETTERS, a recall, failed inspections of manufacturing facilities, evolving warning labels with 2 changes in a 12 month period (April 2010/March 2011) and lawsuits. This history is outlined at YAZRecall .com YAZ DRSP & FDA HISTORY 2000-2011
While many will point to, or argue, that the statistical risk of experiencing a blood clot is rare, or 1 in 10,000, there point makes little difference to girls and women that did not have the benefit of information regarding increased risks. You cannot undertake, or accept a risk, that you are not warned about or that was not disclosed. Only yesterday, in a prior post, we addressed recent reports that Former FDA Commissioner David Kessler, is prepared to testify that information on the safety profile of the pills was not disclosed to FDA in conjunction with the ‘new drug application’ for YASMIN.
(Prior related posts appear here.)
In the end, FDA will hold hearings, consider the evidence, emerging literature, conflicting data and the recommendations of advisors. The EMA and HEALTH CANADA have reached their conclusions in advance of 12.8.11 or litigation.
However, what was known, when and whether it was properly, or timely disclosed, will be the subject of civil jury trials commencing in January 2012. If anything is clear, the advent of nearly 11,000 lawsuits involving claims of personal injury were needed to bring attention to the dangers and inadequate warnings associated with DRSP (DROSPIRENONE) birth control pills. Despite other public health organizations coming to a determination, and FDA publicizing their conclusions, the manufacturer continues to challenge findings, cast doubt over methodologies and ultimately turn a profit in the process. Hopefully, FDA hearings and scheduled jury trials will help all of us be more informed in 2012 on what we should know about the #DRSP (#DROSPIRENONE) family of trademarked birth control pills: YASMIN, YAZ, BEYAZ, SAFYRAL and their generic equivalents.
Gabriel F. Zambrano, P.A., is the author/sponsor of this blog and commentary.
Gabriel F. Zambrano, P.A., is actively investigating cases of serious personal injuries arising out of the use or #DRSP #DROSPIRENONE containing birth control pills. As YAZ LAWYER @YAZATTORNEY he has been providing free updates and information on the risks and dangers of #DRSP #DROSPIRENONE birth control pills for over 2 (two) years. Gabriel F. Zambrano is a Member of the YAZ MDL 2100 Discovery Committee, Lead Counsel and/or Co-Counsel of several women among 1st 100 YAZ Lawsuits filed in YAZ MDL and State Mass Tort Proceedings, has been selected to conduct depositions(s) of BAYER Corporate Representatives by State Liaison Counsel on behalf of coordinated Mass Tort Proceedings in YAZ MDL 2100, and Admitted Pro Hace Vice in PA YAZ Mass Tort Proceedings as Legal Representative of one of 1st 100 DRSP Lawsuits filed in PA Mass Tort Proceedings. Please contact the author with any requests for additional information or a FREE CASE EVALUATION. Additional information is available at YAZRecall.com
The video above was broadcast on January 21, 2011, by “MARKETPLACE: Canada’s Consumer Watchdog”, and was entitled “Spinning A Pill”. The video feature is over 15 minutes and highlights the stories of several #DRSP #DROSPIRENONE survivors of pulmonary emboli. Sadly, it also includes the story of a family that lost a daughter to injuries from a #DRSP #DROSPIRENONE containing birth control pill while in a medical facility.
What makes the “Spinning A Pill” video particularly interesting is that fact that “MARKETPLACE: Canada’s Consumer Watchdog” shows how celebrities and athletes were used to promote use of #DRSP #DROSPIRENONE containing contraceptives. Basically, a popular actress, and athletes were utilized in a direct to consumer campaign to make these pills ‘top of mind’ choices to girls and women. In fact, the trademarked name “YASMIN”, the predecessor to “YAZ”, was emblazoned on the back of a professional volleyball players bikini bottom, and armband, so that it was prominently displayed. Similarly, a younger demographic was arguably targeted, through the public endorsement of a petite and fashionable actress who lauded how use of the pill put her in some form of ‘control’ over her body.
Granted, the above appear to have been efforts to convert Canadian users, or attract consumers to the #DRSP #DROSPIRENONE family of pills in, or from, Canadian markets. Aggressive marketing in the United States has been the subject of FDA Warning Letters, corrective advertising and payments of $20 Million Dollars to the Attorney Generals of 27 States. Regardless, the very ‘in your face’ marketing of these pills has allowed them to continue growing in popularity despite a growing body of scientific evidence, medical literature and open concern by the Food & Drug Administration (FDA).
As noted in prior posts, there are thousands of lawsuits, with estimates over 10,000, in the United States against the manufacturer of #DRSP #DROSPIRENONE containing birth control pills - BAYER HEALTHCARE PHARMACEUTICALS - alleging serious personal injuries and even death. Just this past week, during October 25, 2011 and October 27, 2011, two studies addressing the increased relative risk of blood clots these pills pose to users were released. Only last month, on September 26, 2011, FDA announced that it had only reached preliminary results of their ongoing evaluation of research and evidence on the risks posed by #DRSP #DROSPIRENONE birth controls pills and that it would convene a joint panel of experts on December 8, 2011, to evaluate this information and conduct public hearings. What does the future hold for #DRSP #DROSPIRENONE containing birth control users? How will the FDA act following these hearings and their own finding that these pills present a 1.74x risk of blood clot? We will see.
Despite the recent studies, repeated FDA action, the need for corrective advertisements, $20 Million in fines, and over 10,000 lawsuits, recently released reports indicate that the use and profit motive for #DRSP #DROSPIRENONE containing pills continues as the “YAZ franchise” reportedly grew 16.5%. Yet the entire “YAZ franchise” only seems to add a layer of additional risk to users, while older pills and generics, with a proven safety record remain on the pharmacy shelf. Why? How? Marketing across age groups ranging from early teens and up.
The sponsor and author of this blog, Gabriel F. Zambrano, was featured in a November 9, 2009, story on KTLA News in Los Angeles, California, regarding the initiation of litigation over DRSP (DROSPIRENONE) pills. This particular story focused on the DRSP/EE contraceptive pills and cases being filed against the manufacturer - BAYER HEALTHCARE PHARMACEUTICALS. The video above - KTLA: Birth Control Users Report Serious Problems - Victoria Recano Reports also appears here: KTLA: BIRTH CONTROL USERS REPORT SERIOUS PROBLEMS. The related print story was entitled: BIRTH CONTROL:BITTER PILL was featured by KTLA, as well as The Chicago Tribune.
Gabriel F. Zambrano is the sponsor of www.YAZBitterPills.com which also provides related information on these pills and their dangers, as well as a FaceBook Page: “YASMIN & YAZ CLAIMS” and YAZ LAWYERS @YAZATTORNEY on TWITTER.
In this video, ABC’s Good Morning America (#GMA), and ABC Nightline report, on the dangers of #DRSP #DROSPIRENONE pills and cite #BAYER as stating they are safe and effective when used as directed. The #DRSP #DROSPIRENONE family of contraceptives are the subject of nearly 10,000 lawsuits claiming personal injuries. These pills include the trademarked: #YASMIN #YAZ #BEYAZ #SAFYRAL and their generic equivalents.
On September 26, 2011, the FDA scheduled public hearings for December 8, 2011, regarding continued concerns of blood clots, as well as a growing body of scientific evidence that #YASMIN #YAS or #DRSP #DROSPIRENONE birth control pills present consumers with an increased blood clotting hazard of 1.5x to 3.0x. Both #YASMIN & #YAZ have been the subject of FDA WARNING LETTERS for their aggressive marketing campaigns, which the FDA complained overstated their effectiveness, indicated use and failed to adequately underscore risks. The potential for an increased risk of blood clots, from #DRSP #DROSPIRENONE, was initially articulated in a British Medical Journal (BMJ) article during August 2009. Since then, there have been additional independent studies that challenge findings the manufacturer claims are accurate.
Gabriel F. Zambrano, P.A., is the sponsor of this blog and commentary. Gabriel F. Zambrano, P.A., is an advocate of the dangers of #DRSP #DROSPIRENONE pills and posts related news @yazattorney @gfzambrano and @recallattorneys. Gabriel F. Zambrano, P.A. is actively investigating DRSP LAWSUITS, and representing women that suffered personal injuries from DROSPIRENONE containing birth controls pills. Please REPOST.
When it comes to the promotion of the #DRSP #drospirenone family of birth control pills, have you really forgotten about the ‘corrective ads’? #Recall the ads? Above is a link from YouTube to the FDA required corrective ad that followed an FDA Warning Letter. This ad was part of a $20 Million Dollar Settlement with 27 States and the Attorney’s General of those states for violation of a prior settlement agreement regarding #BAYER’s Blockbuster drug - Baycol.
Approximately a year later, MDL (Multi District Litigation) and coordinated mass tort proceedings in PA, CA & NJ were commencing with lawsuits alleging injuries that include:
- Heart Attacks
- Pulmonary Emboli (PE)
- Deep Vein Thrombosis (DVT)
- Gallbladder Removal and complications from invasive surgery
Between April 2010 and April 2011 there have been two (2) changes to the warning label inserted in the box that comes with this 4th Generation family of birth control pills. Those changes now warn of an increased risk of blood clots but were initially an effort - in my opinion - to spin recently published science in favor of the manufacturer. These changes, and ongoing evaluations of the dangers associated with #DRSP #drospirenone pills, are little consolation to girls and women that wish they had never taken one of these pills. Many, but not all are now litigants in cases described above. Trials are scheduled in early 2013 in front of civil juries to determined what was known by the manufacturer, and whether they failed to adequately disclose already known risks to unsuspecting women. Given that #BAYER developed and promoted #DRSP #drospirenone as a new and unique progestin with multiple ‘benefits’ it is becoming clear that girls and women, were arguably, not fully informed.
I have already commented in prior posts on the 9.26.11 FDA update regarding the conflicts in scientific evidence and scheduled advisory hearings to discuss the now recognized increased risk of taking a #DRSP #drospirenone birth control pill. Whether the risk is 1.5x or 3.0x more likely to create a blood clot is presently debated. However, the avoidable suffering of girls, women and their loved ones is not as 9,500+ lawsuits claiming a litany of ailments continue to mount.
I Gabriel F. Zambrano, P.A., am the author and sponsor of this commentary and blog. I have been actively investigating and representing victims of DRSP drospirenone birth and continue to provide a free case evaluation and screening. Additional, public information, new stories, science and a history of this litigation exists at the following on Facebook: “Yasmin & YAZ Claims/Lawsuits”. I also provide related news and updates via Twitter @yazattorney.
Bayer is the manufacturer of the novel family of #DRSP (#drospirenone) birth control pills that include: #YAZ #Yasmin #Ocella #BEYAZ and #SAFYRAL. The original Yasmin & YAZ pills, as well as certain generic versions, are the subject of alleged deaths, strokes, deep vein thrombosis, pulmonary emboli, cardiac events, gallbladder removal, pancreatitis and related medical complications, in the US. A Canadia Class Action is also pending with over 1,000 lawsuits.
A number of studies have come out in the past two years highlighting the potential increased risk of blood clots from DRSP pills. Yasmin & YAZ have been the subject of Four FDA Warning Letters, a #recall, $20M in fines for improper promotion, corrective TV ads, and Two changes in the warning label.
Gabriel F. Zambrano, P.A., has been investigating and representing girls and women that have suffered injuries from DRSP pills for the past three years. Additional, non-confidential information regarding the litigation, news reports and other issues is available at on Facebook at “Yasmin & YAZ Claims”
#DRSP birth control pill lawsuits continue to climb in US. Over 7,000 lawsuits pending. Lawsuits include claims for death, strokes, cardiac problems, pulmonary emboli, deep vein thrombosis, pancreatitis and gallbladder removal. Public links and information on the background to the litigation and non-confidential information via Yasmin & YAZ Claims and @yazattorney on Twitter.
Gabriel F Zambrano, P.A., is investigating cases, and representing girls, women and families that have suffered injuries, damages or loss of a loved one from DRSP pills and is the sponsor of this blog and commentary.