YAZ RECALL or Updated Warning Labels (Again)?

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.