DRSP (DROSPIRENONE) containing birth control now has over a decade long history with FDA. Generic DRSP (DROSPIRENONE) pills are now available and compete with the original trademarked branded products. However, their legacy arguably evidences a troubled and concerning one as illustrated below.

YAZ claimed benefits "Beyond Birth Control"

The information below is a summation of publicly available information from FDA.GOV, and other published sources, but is not necessarily an exhaustive history. Rather, it represents significant milestones relating to regulatory action(s), FDA intervention, FDA WARNING LETTERS, FDA SAFETY COMMUNICATIONS, the release of medical literature and litigation precipitated by injuries that are claimed to be linked to the use of a DRSP (DROSPIRENONE) containing birth control pill:

• 2000  YASMINELLE approved in EUROPE. YASMINELLE was predecessor to YASMIN.
• “DUTCH WARNING” in response to several deaths and adverse events upon launch of YASMINELLE in EUROPE.
• 2001  YASMIN gains FDA approval for use in United States as hormonal birth control with 3mg of DRSP (DROSPIRENONE).
• 2003  FDA WARNING LETTER issued on July 10, 2003, to then manufacturer BERLEX LABORATORIES over direct to consumer marketing of YASMIN that claimed or depicted chemical superiority. Sales messaging invited women to “Ask about YASMIN, and the difference a little chemistry makes” promoting DRSP (DROSPIRENONE) as chemically beneficial and superior to existing hormonal contraceptives. FDA identified advertising campaign as “misleading because it makes implied clinical superiority claims to other combination oral contraceptives and minimizes the important risk information that distinguishes YASMIN from other combination oral contraceptives. As a result, the TV Ad raises significant public health and safety concerns“.
• 2006  YAZ approved in US as hormonal birth control with 3mg of DRSP (DROSPIRENONE) in March 2006.
• 2006  YAZ approved in US as having an indication for PMDD (Premenstrual Dysphoric Disorder) a condition to be diagnosed pursuant to criteria in DSM-IV. Indication approved based upon short term and limited study. See “YAZ BIRTH CONTROL CONFUSION: PMDD vs PMS” on YAZRecall for more information and distinctions between PMDD and PMS. YAZ PMDD indication was approved during October 2006.
• 2007 YAZ approved for use in “acne vulgaris” or “moderate acne” in January 2006.
• 2008  FDA WARNING LETTER issued on October 3, 200, to BAYER HEALTHCARE PHARMACEUTICALS, for TV Ads, “Not Gonna Take It” and “Balloons“, that FDA determined are “misleading because they broaden the drug’s indication, overstate the efficacy of YAZ and minimize serious risks associated with the use of the drug“. FDA went on to not that “[t]hese violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ“.
• 2009 “Corrective Advertising” TV Advertising is run to “clear up” misleading promotional campaign that prompted  FDA 2008 FDA WARNING LETTER(S). BAYER is required to pay to run corrective advertising campaign and pay $20 Million Dollars for violation of consent decrees in 27 States from prior drug litigation settlement with Attorneys General.
• 2009  FDA WARNING LETTER  issued on April 26, 2009, relating to the failure of Internet advertising to present ‘fair and balanced’ information on Google search results for DRSP (DROSPIRENONE) containing birth control pills YASMIN & YAZ. FDA notes a complete failure to provide any risk information for YAZ, LEVITRA & MIRENA (IUD/IUS).
• 2009 March 2-10, 2009 FDA inspections of DRSP (DROSPIRENONE) containing birth control manufacturing facilities result in FDA WARNING LETTER over failure to follow “good current manufacturing processes“or CGMP.
• 2009 FDA WARNING LETTER issued on August 5, 2009, regarding inspections of Bergkamen, Germany facility and findings of significant deviations from US current good manufacturing practices (CGMP).
• 2009 In mid-August 2009, BMJ (British Medical Journal) releases published studies evaluating blood clot risk of DRSP (DROSPIRENONE) containing YASMIN and compares it with other available hormonal contraceptives.
• 2009 In August/September Federal Multi District Litigation (MDL) and coordinated Mass Tort Proceeding are formally established and initiated in centralized venues to handle lawsuits arising out of DRSP (DROSPIRENONE) side effects and injuries from use of YASMIN, YAZ and then emerging generic OCELLA.
• 2009 FDA Enforcement Report identifies recall of DRSP (DROSPIRENONE) YAZ and OCELLA pills for “CGMP deviations: Out of Specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was with specification“. Intended for Nationwide distribution in US 32,856 (3 blister packages/box) of YAZ and 122,208 boxes (3 blister packages/box) of OCELLA were effectively recalled. FDA’s standard of proof to refuse entry of goods into US may be based upon CGMP deviations and other criteria.
• 2010 DRSP (DROSPIRENONE) containing birth control pills have FDA approval for label change that incorporates references to certain studies and include references to results. Label changes occur during April 2010, approximately three (3) years after copyrighted label of April 2007, has been included in packaging.
• 2010 DRSP (DROSPIRENONE) containing birth control pill BEYAZ is approved by FDA in September.
• 2010 DRSP (DROSPIRENONE) containing birth control pill SAFYRAL is approved by FDA in mid-December.
• 2011 DRSP (DROSPIRENONE) containing birth control YAZ label to change and warn, or alert, about risk of blood clot being greater in 1st six (6) months of use after initial start of regimen or restarting hormonal birth control after a four (4) week or greater pill free interval. This label change is 2nd in twelve (12) month period and occurs in March.
• 2011 BMJ (British Medical Journal) release two (2) epidemiological studies comparing DRSP (DROSPIRENONE) containing YASMIN to other hormonal contraceptives in April
• 2011 EMA (European Medicines Agency) announced on May 27, 2011 that it is updating product information on DRSP (DROSPIRENONE) birth control regarding risks of blood clots after review of all available data.
• 2011 FDA issues DRUG SAFETY COMMUNICATION alerting public to BMJ (British Medical Studies) of April 2011 and growing scientific debate, as well as conflicting evidence, in interpretation of studies evaluating blood clot risk of DRSP (DROSPIRENONE) containing birth control pills.  FDA DRUG SAFETY COMMUNICATION: SAFETY REVIEW OF POSSIBLE INCREASED RISK OF BLOOD CLOTS WITH BIRTH CONTROL PILLS CONTAINING DROSPIRENONE is publicly posted on May 31, 2011 on FDA.GOV  At this time, FDA noted that the EMA (European Medicines Agency) announced on May 27, 2011, that it was updating the product information on oral contraceptives containing DRSP (DROSPIRENONE) and EE (Ethinyl Estradiol) regarding the risk of blood clots after review of available data including recently published BMJ studies from April 2011. EMA concluded that data had shown DRSP (DROSPIRENONE) containing birth control was associated with a higher blood clot risk than other birth control pills. At the time, FDA reported it was evaluating conflicting results from these studies and looking at all then currently available information to fully asses the risks and benefits associated with DRSP (DROSPIRENONE) containing birth control pills.
• 2011 FDA DRUG SAFETY COMMUNICATION UPDATE on September 26, 2011 which stated FDA had not yet reached a conclusion, “but remains concerned“, about the potential increased risk of blood clots from use of DRSP (DROSPIRENONE) birth control. Given conflicting nature of findings, as well as preliminary data from FDA funded study, FDA schedules public hearings for December 8, 2011 of Reproductive Health Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss the risks and benefits and specifically risk of blood clots.
• October 8, 2011 – BAYER acknowledges being ‘served’ with Civil Complaints for personal injuries by 10,400 litigants in September 30, 2011 Stockholder’s Newsletter. Sixty (60) days before the FDA is to convene a joint panel of experts as an Advisory Committee on the future of DRSP (DROSPIRENONE) containing birth control pills.

DRSP (DROSPIRENONE) Lawsuits Mount 10,400 as of October 2011.

• 2011 FDA DRUG SAFETY COMMUNICATION UPDATE on October 27, 2011 and FDA funded study is posted on FDA.GOV  FDA releases final report of FDA funded study evaluating risk of blood clots. FDA’s study, “Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints“, DRSP (DROSPIRENONE) was associated with a “significantly higher risk” of blood clots, 1.74x in comparison to other pills. This has been restated to be a 74% higher risk of blood clots.  FDA notes that this FDA funded study “provides another positive finding to the increasing body of evidence linking DRSP to increased risk” of blood clots relative to other forms of contraceptive pills.
• 2011 On November 29, 2011, FDA approved WATSON PHARMACEUTICALS’ generic version of the trademarked YAZ which will be known as VESTURA.
• 2011 HEALTH CANADA, December 5, 2011, announces conclusion of ‘safety review‘ of DRSP (DROSPIRENONE) pills and concludes 1.5x-3.0x higher risk of blood clots based upon available data despite manufacturer claiming otherwise.
• 2011 – December 6. Reports emerge of Former FDA Commissioner, David Kessler, unsealed testimony that is critical of data, and non-disclosure of risk information, related to DRSP (DROSPIRENONE) pills in the new drug application process.
• 2011 – December 8, 2011 – FDA HEARINGS are pending.
• 2011 – December 8, 2011.  In a 21-5 vote, an overwhelming majority of the Advisory Committee agrees that DRSP (DROSPIRENONE) containing birth control labels do not adequately reflect the risk benefit profile. A narrow vote of 15-11 concludes that the benefits outweigh risks and DRSP (DROSPIRENONE) containing pill avoid a recommendation of market withdrawal.
• 2011 – December 2011. Formal FDA action and approval of updated warnings is pending. Any update will mark third (3rd) change to warning labels since 2009 and in less than twenty-four (24) month period.
• January 2011 – Reports Emerge in BMJ (British Medical Journal), MedPage Today, Washington Monthly and REUTERS that members of FDA Advisory Committee that voted on future of DRSP (DROSPIRENONE) birth control pills allegedly had financial ties to BAYER the ‘sponsor’ of the birth control pills at the heart of FDA hearings and over 10,000 Lawsuits. Calls for an investigation, re-vote or reconsideration are publicly sought by reporters and POGO – Project on Government Oversight. POGO’s Letter is dated January 11, 2011 and was sent to Margaret A. Hamburg, M.D., Commissioner of FDA.
• January 31, 2011 – Multi District Litigation Bellwether Case Ordered to Special Master for Mediation Settlement Conference(s). State Court Mass Tort Proceedings similarly initiate Mediation Settlement Conferences.
• February 8, 2011. Sixty (60) Days after FDA Advisory Committee Hearing no official or formal FDA action on DRSP (DROSPIRENONE) containing birth control pills.
• April 10, 2012. FDA announces the DRSP (DROSPIRENONE) family of contraceptives will carry a revised warning label communicating the potential for increased risks of blood clots. This will reflect emerging science, since 2009, and inform prescribers and consumers, for the first time, that the pills may present a 3x higher risk of blood clots than other pills. FDA’s own study, released in October 2011, found the pills were 74% more likely to cause a blood clot. Regrettably, FDA chooses to include information regarding the risk of pregnancy and compares that risk to the potential for blood clots, providing for confusion. Whether this labeling change will be sufficient in light of the 15-11 and 21-5 vote regarding the DRSP (DROSPIRENONE) pills remains open to question.
• April 13, 2012. Days after FDA announces DRSP (DROSPIRENONE) containing birth control pills will carry new warnings reflecting the exponentially higher risk of blood clots, BLOOMBERG reports on related blood clot lawsuit settlements $110 Million U.S. Dollars.

• April 26, 2012. BLOOMBERG PROVIDES A YAZ YASMIN BEYAZ SAFYRAL SETTLEMENT UPDATE. BLOOMBERG, in “BAYER YASMIN LAWSUITS SETTLEMENTS CLIMB TO $142 MILLION” updates their story of April 13, 2012 and reports that BAYER has informed stockholders, in a “Stockholder’s Newsletter“, that it has begun settling YASMIN YAZ BLOOD CLOT lawsuits on a rolling case by case basis in the U.S.. BLOOMBERG reports settlements of $142 Million U.S. Dollars and cites Wall Street Analysts as estimating BAYER’S liability will approach, or exceed $2.65 Billion over the Blockbuster Birth Control Pills. The story by Jef Feeley and Margaret Cronin Fisk is available here.

• 

  DROSPIRENONE DRSP LAWSUIT SETTLEMENTS REPORTED APRIL 2012

YASMIN & YAZ FDA History Outlined above.