MARKETPLACE, CANADA’S CONSUMER WATCHDOG, investigates #YASMIN, #YAZ birth control pills that contain #DRSP #DROSPIRENONE. HEALTH CANADA announced this week that it had concluded a ‘safety review’ of the pills and found they presented a 1.5x to 3.0x higher risk of blood clots than other pills. This story was aired prior to this announcement in early 2011. FDA is holding hearings 12.8.11-12.9.11 to consider blood clot risks of these pills and other contraceptives. In May 2011, the EMA (European Medicines Agency) announced the pills presented a 1.5x to 3.0x higher risk of blood clots. FDA funded studies concluded the pills were 74%, or 1.74x. higher risk in comparison to other hormonal contraceptives it considered.
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
With FDA hearings looming in the US, on 12.8.11, HEALTH CANADA has completed a “safety review” of available science and data related to #DRP (#DROSPIRENONE) birth control pills and announced that the “overall, the body of current evidence suggest that the risk of blood clots is 1.5 to 3 times higher with oral contraceptives that contain #drospirenone relative to those that contain levonorgestrel, a different hormone”. In “YASMIN BIRTH CONTROL CLOT RISKS UPDATED”, CBCNews, reports on HEALTH CANADA’s findings and completed ‘safety review’ of the popular #YASMIN & #YAZ family of birth control pills.
This announcement is consistent with prior determinations in other studies published in the British Medical Journal (BMJ) beginning in 2009. The manufacturer in the US, BAYER HEALTHCARE PHARMACEUTICALS, has repeatedly denied that their product is higher risk and actually printed a label during April 2010 that claimed studies presenting findings of higher risk contained errors or were statistically unreliable. This finding by HEALTH CANADA, as well as subsequent findings appear to clearly call these claims into question. In October, FDA released findings from their own study that came to similar conclusions and found 74% higher risk, or 1.74x, in comparison to other birth control pills it considered. Prior to the release of this data, FDA announced that it had schedule hearings between two panels to consider conflicting evidence, emerging science and to help in the evaluation of the blood clot risks presented by DRSP (DROSPIRENONE).
Sadly, there are women that did not have the benefit of the ‘evolving warnings’ that only came into being after mass tort lawsuits were filed in the United States. There are 10,500 lawsuits claiming personal injuries in the US for women that allege they suffered blood clots, deep vein thrombosis, pulmonary emboli, strokes, cardiac events and in some cases death. Based upon the continually ‘evolving warnings’ it cannot be said these women were warned of known risks by the manufacturer, and other reports today call into question what was known, when it was known and if in fact it was disclosed to the FDA for consideration.
Updates regarding this subject, FDA hearings and news reports will be provided as they become available. Additional information is also available at YAZRecall.com
Gabriel F. Zambrano, P.A., is the sponsor of this blog, author of this commentary and actively involved in representing survivors of #DRSP (#DROSPIRENONE) containing birth control. Gabriel F. Zambrano, is a Member of the YAZ MDL (Federal Multi District) Discovery Committee, Representative Counsel and/or Lead Counsel to Women injured by DRSP (DROSPIRENONE) birth control, including several of the YAZ 1st 100 Discovery Bellwether Cases.