Following the convening of a joint panel of experts on 12.8.11 to discuss multiple independent studies related to the DRSP (DROSPIRENONE) family of contraceptives, on 4.10.12 the U.S. Food & Drug Administration issued the “FDA DRUG SAFETY COMMUNICATION" below. This communication has been reported in related news stories and "PR" from the manufacturer, BAYER HEALTHCARE PHARMACEUTICALS in a fashion that downplays the serious risk that this family of contraceptives, and their generic equivalents present to users. Moreover, the history of these pills, FDA sanctions against the manufacturer, over 11,000 pending civil lawsuits, allegations of "conflicts of interest" in the 12.8.11 Ad Comm Meeting, as well as testimony from Former FDA Commissioner D. Kessler regarding missing or hidden data is being complete ignored in recent reports. More information on the above and YAZ CLAIMS is available here YAZ RECALL.
FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/11:  Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone.

Safety Announcement 

[4-10-2012] The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin.  Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.  See Table 1 for a list of drospirenone-containing products.

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use. 

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not.  The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots.  For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills. 

The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.  The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period. 

These studieswere discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.

Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011.  The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins.  Previously published studies had reported conflicting findings.  The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives.  The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.

Today’s communication is in keeping with FDA’s commitment to inform the public about the Agency’s ongoing safety review of drugs.  FDA will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available.

For more information: http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm

Following the convening of a joint panel of experts on 12.8.11 to discuss multiple independent studies related to the DRSP (DROSPIRENONE) family of contraceptives, on 4.10.12 the U.S. Food & Drug Administration issued the “FDA DRUG SAFETY COMMUNICATION" below. This communication has been reported in related news stories and "PR" from the manufacturer, BAYER HEALTHCARE PHARMACEUTICALS in a fashion that downplays the serious risk that this family of contraceptives, and their generic equivalents present to users. Moreover, the history of these pills, FDA sanctions against the manufacturer, over 11,000 pending civil lawsuits, allegations of "conflicts of interest" in the 12.8.11 Ad Comm Meeting, as well as testimony from Former FDA Commissioner D. Kessler regarding missing or hidden data is being complete ignored in recent reports. More information on the above and YAZ CLAIMS is available here YAZ RECALL.

FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/11:  Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone.

Safety Announcement

[4-10-2012] The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin.  Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.  See Table 1 for a list of drospirenone-containing products.

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not.  The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots.  For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills. 

The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.  The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period. 

These studieswere discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.

Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011.  The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins.  Previously published studies had reported conflicting findings.  The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives.  The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.

Today’s communication is in keeping with FDA’s commitment to inform the public about the Agency’s ongoing safety review of drugs.  FDA will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available.

For more information: http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm

Yaz Panel Was Filled With ‘Irregularities’: Advocates

PHARMALOT’S, Ed Silverman, from the Publishers of PharmaLive.com, examines the state of DRSP (DROSPIRENONE) birth control and the FDA Advisory Committee hearings of 12.8.11.
"Three months ago, an FDA advisory panel voted 15-to-11 that the benefits of the Yaz and Yasmin birth control pills outweigh the risks, and the drugs should remain on the market, albeit with added information about a risk of blood clots. The decision followed a long-running controversy - studies by Bayer, which sells the pills, found there is no risk, while other studies said risk is evident (see this).

But controversy also surrounded the meeting. Beforehand, the FDA yanked Sid Wolfe of the Public Citizen Health Research group from the panel due to an intellectual conflict of interest (read here). Afterwards, concerns were raised because four panel members held ties to Bayer, either as paid consultants or in the form of research funding, but the FDA did not disclose the conflicts, prompting the Project on Government Oversight, a watchdog group, to ask the FDA to convene an entirely new meeting (read this and this).

Now, a coalition of women’s health groups charges there were several irregularities that may well have altered the outcome. In a letter to FDA commish Margaret Hamburg, the coalition complains, in particular, that the key question panelists had to answer, which determined the outcome of the voting, was vague and confusing. And they maintain that several panelists who are practicing obstetricians and gynecologists may also have held intellectual conflicts that swayed their votes.

“Obviously, we can’t predict how people would have voted with different wording…,” the coalition wrote. “However, the vaguely (and, we believe, inappropriately) worded question and the difference in how conflicts of interest were handled raises very serious questions of bias.” The groups that signed the March 9 letter include the Jacobs Institute of Women’s Health, the National Research Center for Women & Families, the National Women’s Health Network and Our Bodies Ourselves.

The panelists were asked to vote on whether “the benefits of the DRSP-containing oral contraceptives for prevention of pregnancy outweigh their risks.” DRSP is drospirenone, which is a hormone contained in the Yaz and Yasmin pills. After voting, each panelist was asked to explain their vote, and the coalition noted that those who voted “no” explained that safer oral contraceptives were available.

However, the letter also notes that almost all of the 15 who voted “yes” indicated they voted on a comparison of risks and benefits compared to pregnancy, rather than on whether the risks and benefits of oral contraceptives containing DRSP outweigh risks and benefits compared to other oral contraceptives. These are two different issues, the coalition writes, the befuddled some panelists.

The coalition pointed to panelist Elaine Morrato, who voted “yes,” but said: “However, if the standard is to make a comparative, which… I just compared it in the absolute sense. I would agree that I didn’t see any benefit of the product that’s well demonstrated for Yasmin, perhaps for Yaz. And so if the regulatory standard would be that you’d have to demonstrate a comparative benefit, then I would vote no.” This would have changed the vote to 14-to-12.

Another panelist, Anne Burke, voted “yes,” and according to the letter, said: “I don’t think I was expecting it to be more effective than other pills on the market, and while I acknowledge that there does seem to be a moderate increased risk, it’s still lower than the risks of pregnancy. And like some other folks who have spoken, a no vote sounded like it would be - to take the product off the market. I’m not quite sure that’s necessary at this point.”

And panelist Julia Johnson voted “yes” and said: “I am significantly concerned regarding the most recent FDA study…I would like to see comparison with another U.S. study. I think that’s absolutely critical. I do not think there is one advantage for this pill over any other for use for women. If indeed there is truly an increased risk, then I would vote differently,” according to the letter. Both Johnson and Burke had ties to Bayer.

Meanwhile, seven other panelist are practicing OB/GYNs. “Given that practicing OB/GYNs routinely prescribe oral contraceptives, and that these physicians have likely made a decision to either prescribe or not prescribe/stop prescribing DRSP-containing OCs prior to the meeting, this certainly raises an intellectual conflict of interest as great as that attributed to Dr. Wolfe. Had they been ask to participate in the panel but not vote, as Dr. Wolfe was, this clearly would have resulted in a majority vote that the benefits do not outweigh the risks,” the coalition writes to Hamburg.

How so? Here is the math: If Wolfe voted no and at least one of the three panelist who expressed strong concerns voted “no” on the more specific question of whether the benefits outweigh the risks compared to other pills, the vote would have been 14 “no” and 13 “yes.” But if Wolfe and those with a financial conflict had not been allowed to vote, the final vote would have been 11-to-11. And if Morrato had been counted as a “no,” given her confusion, then the vote would have 12-to-10 against allowing the Bayer drugs to remain on the market, the coalition writes (here is the letter).

The coalition, however, stopped short of asking the FDA to hold a new meeting and, instead, wants Hamburg to review its policies “that resulted in biases” so a repeat does not occur. We asked the FDA, which previously indicated the POGO request for a new meeting would be reviewed, for a reply and will update you accordingly. [UPDATE: An FDA spokeswoman writes us to say the agency will respond directly to the coalition.]”

http://www.pharmalot.com/2012/03/yaz-panel-was-filled-with-irregularities-advocates/

Did FDA Panelist with Ties to BAYER prevent a YAZ RECALL?

THE YAZ MEN: MEMBERS OF FDA PANEL REVIEWING THE RISKS OF POPULAR BAYER CONTRACEPTIVE HAD INDUSTRY TIES.

January 09, 2012 9:24 AM

 The Yaz Men: Members of FDA panel reviewing the risks of popular Bayer contraceptive had industry ties

By Jeanne Lenzer and Keith Epstein as Published in the WASHINGTON MONTHLY.

Last month, the U.S. Food and Drug Administration convened a committee of medical experts to weigh new evidence concerning the potential dangers of drospirenone, a synthetic hormone contained in popular birth control pills including Bayer AG’s Yaz and Yasmin. In a decision that helped ensure the continued presence of these drugs on American pharmacy shelves, the committee concluded by a four-vote margin that the benefits of drugs with drospirenone outweigh the risks. However, an investigation by the Washington Monthly and the British medical journal BMJ has found that at least four members of the committee have either done work for the drugs’ manufacturers or licensees or received research funding from them. The FDA made none of those financial ties public.

Yaz and Yasmin are among Bayer’s top selling pharmaceutical products. According to the German drug manufacturer, over 4 million women worldwide use Yasmin alone. But the drug has also sparked growing controversy in recent months. A series of studies published in BMJ have shown that users of pills containing drospirenone have an increased risk of blood clots, which can cause deep vein thrombosis, pulmonary embolism, stroke, heart attack and death. And thousands of women have filed a lawsuit against Bayer, saying they were injured by Yaz or Yasmin.

Other Bayer products containing the hormone drospirenone are Beyaz and Safyral. In addition, four companies—Bayer, Teva, Watson and Sandoz—sell five generic versions of the drugs evaluated by the committee last month.

The FDA’s decision not to reveal its advisors’ relationships with the drugs’ manufacturers and Bayer raises serious questions about the agency’s treatment of potential conflicts of interest, a historically problematic area for the department. In 2004, controversy erupted over another FDA advisory hearing—involving the painkiller Vioxx—when it became clear that advisors with financial conflicts of interest were more likely than those without conflicts to vote that Vioxx was safe and should be allowed to stay on the market. The drug was ultimately withdrawn after a study showed it was associated with approximately 60,000 deaths. In 2008, partly in response to this uproar, the agency issued a new guidance on how to handle conflicts of interest among its advisors, stating that it wanted to reduce “bias” and to be more “transparent.”

The agency’s handling of the drospirenone hearings casts major doubt on how far it has gone to attain those goals.

What’s more, interviews and records also show that the drospirenone advisory committee, when it voted last month, lacked significant information about increased risks to the health of women using contraceptives containing drospirenone.

The FDA ordered the safety review of drugs containing the hormone after three articles published in the BMJ found an increased incidence of blood clots among users of the pills. The advisors were given these studies prior to the December 8 meeting. However, the panel was not shown documents from a report by David Kessler, a former FDA commissioner and an expert witness in the lawsuit filed against Bayer on behalf the women who say they were injured by Yaz and Yasmin. Kessler’s report cites internal Bayer corporate documents that suggest the company had withheld safety data from the FDA.

The documents show that in 2004, Bayer scientists reported in a draft analysis that Yasmin incurs a “several-fold increase” in reporting rates for blood clots compared to three other oral contraceptives, and that Yasmin’s rate of all serious adverse events was “10 fold higher” than that of other products.

In his report, Kessler writes that Bayer failed to report safety data to the FDA, engaged in off-label promotion of the pills, and paid $450,000 to a high profile gynecologist to sponsor her book tour in which she promoted such off-label uses.

Kessler’s report, originally under seal, was not released until December 6, two days prior to the advisory meeting. The FDA said it could not give the advisors the information because the date to submit documents had passed.

***

The FDA relies on some 50 advisory committees to obtain “independent” expert advice and “maintain the public trust.” Recommendations on evidence for safety and efficacy can lead to drug approvals and withdrawals; while nonbinding, recommendations by such committees can move stock prices and are generally regarded as indicators of official FDA action.

Under FDA guidelines, when advisory committee members have a financial relationship with a drug company whose product is under review, the agency can issue waivers that acknowledge the advisors’ links to industry but allow them to vote if their expertise is needed and no other specialists are available. Such waivers often serve as the only public signal that advisors have financial conflicts of interest. In the hearings on drospirenone, the FDA issued none.

And yet, according to public records, recently unsealed court documents, and interviews with some of the FDA advisors, at least four of the advisory committee members in this case have served as paid researchers, consultants, “key opinion leaders,” or speakers for Bayer or other manufacturers or licensees of drospirenone. A fifth advisor agreed to serve as a consultant but never executed the agreement. A sixth received consulting fees from a law firm representing Bayer.

In a 15-to-11 vote, the committee decided that the benefits of drospirenone outweighed its risks.Had those members with undisclosed conflicts of interest voted the other way, the committee would have come to the opposite conclusion. The committee also voted 21 to 5 to change the drug labels to warn that the hormone can cause blood clots. But the panel stopped short of recommending that the labels should warn that they are more likely than other contraceptive pills to cause blood clots. Instead the experts suggested that the labels say that the evidence about blood clots is “conflicting.”

Ironically, while the FDA allowed voting by advisors with business connections to drospirenone, the agency did bar another advisor—Sidney M. Wolfe, the panel’s lone consumer advocate—on the grounds that he has an “intellectual conflict of interest.” Wolfe, a former researcher, is a frequent critic of FDA practices on behalf of the advocacy group Public Citizen. Wolfe, the author of the consumer guide Good Pills, Bad Pills, had marked Yaz with a “do not take” advisory to readers. Jerome Hoffman, professor emeritus of medicine at UCLA, questioned Wolfe’s exclusion from the panel: “The idea that because he has an opinion on data that already exist he should be prevented from voting is nutty.”

Each of the advisors with ties to manufacturers told the Washington Monthly andBMJ that they fully disclosed their ties to the FDA, and there are no indications that the advisors failed to make required disclosures to the agency. The FDA, however, has declined to make public advisors’ financial conflict of interest forms, explaining that the forms are “confidential” and no information from them can be shared under a section of the Ethics in Government Act.

When asked whether the agency was aware of any financial ties between its advisors and manufacturers or distributors of drospirenone, FDA spokeswoman Morgan Liscinsky said, “No waivers were issued.”

But the committee’s financial ties to Bayer begin with no less than its acting chair. Julia Johnson, a professor of obstetrics and gynecology at the University of Massachusetts Medical School, conducted four clinical trials—including one of drospirenone as hormone replacement—for Bayer or its subsidiary Berlex, a manufacturer of drospirenone. She said in an e-mail, “The FDA is very vigilant on examining potential conflicts of interest and was aware of all my research.” When asked for an interview, she said, “The U.S. FDA states that I cannot speak about the meeting.”

Another advisor with ties to industry is Paula Hillard, a professor of obstetrics and gynecology at Stanford School of Medicine who has served as a paid consultant to Bayer Schering. Dr Hillard said she had fully complied with all FDA disclosures and referred the Washington Monthly and BMJ to the FDA for further questions. The FDA declined to respond to any questions, again citing the confidentiality clause of the Ethics in Government Act.

Elizabeth Raymond, a senior medical associate at Gynuity Health Projects in New York and another member of the committee, conducted studies funded by Barr, which has a licensing agreement with Bayer for generic versions of Yaz. Dr Raymond said that the FDA was “fully aware of all of my relevant current and past activities.”

Anne E. Burke, an assistant professor of gynecology and obstetrics at Johns Hopkins University in Baltimore, has received research funding from Bayer-Berlex and Duramed, which has a licensing agreement with Bayer for generic Yaz and Yasmin. Dr Burke said that she fully disclosed this to the agency.

According to Dr Kessler’s report, an internal Bayer document indicated that a fifth advisor received payment from Bayer, but that advisor told the Washington Monthlyand BMJ that although she initially agreed to serve as a consultant for Bayer, the company never pursued the agreement. She said FDA records indicated that she had ties to Bayer due to her disclosure about her agreement, but after she was nominated to be on the drospirenone advisory committee, she corrected the error.

A sixth advisor, meanwhile, confirmed that he received consulting fees from a law firm representing Bayer in 2006. He told BMJ and the Washington Monthly that he did not disclose the information to the FDA because the FDA “did not require information for that time frame for consulting unrelated to the meeting topic.”

Bayer spokesperson, Rosemarie Yancosek, said in an e-mailed statement: “Bayer had no input on who serves on the U.S. FDA Advisory Committee panel as the FDA has its own process for selecting panel members. Furthermore, it is Bayer’s understanding that the FDA has a procedure for determining conflicts of interest for potential panel members.”

The FDA does indeed have such a procedure, but critics argue that its guidelines define conflicts of interest too narrowly and provide too much flexibility in how they are applied. The guidelines are technically “suggested or recommended, but not required” provisions (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf). Whether an advisor can participate depends on “whether the discussion at the meeting or outcomes of the meeting will have a direct and predictable effect on the individual’s interest.” For instance, someone who was previously involved in another role for a manufacturer, or whose university received money from a manufacturer, may be allowed to participate. Even having a contract for $100,000 over a five-year period would not necessarily exclude an advisor, according to the guidelines.

Despite the FDA’s frequent claims that there aren’t enough experts independent of industry, a list of over 100 industry-independent experts has been presented to the agency - yet none of those experts has been tapped as an advisor.

The Project on Government Oversight, a Washington-based nonpartisan watchdog group, plans to raise concerns about the FDA’s conflict of interest policies in a letter to the agency’s top official, Margaret Hamburg.

“It shouldn’t require a lawsuit and investigative journalism to learn about these kinds of conflicts,” said the group’s executive director, Danielle Brian. “The Yaz case puts FDA’s feckless ethics policy into stark relief. It also reveals the human impact of conflicts of interest and why we need an FDA that shuns even the appearance of such conflicts.”

The organization intends to urge the FDA to routinely disclose industry ties and more aggressively determine whether an advisor has a conflict. “Right now,” said Brian, “the bar for considering whether an advisor has a conflict is too high.”

Jeanne Lenzer and Keith Epstein collaborated on this article. Lenzer is a medical investigative journalist based in New York. Epstein is a Washington-based investigative editor and writer.

(Source: yazrecall.com)

MARKETPLACE previously aired the video above to explore the risks, and growing evidence, confirming increased risks of blood clots, that DRSP (DROSPIRENONE) containing birth control pills presented. They have ‘updated’ the original Spinning A Pill Story (Update) and it is available via this link.

The Spinning a Pill Update confirms that HEALTH CANADA has found the YASMIN, YAZ and DRSP (DROSPIRENONE) family of contraceptives present higher risks of blood clots to users. The risk is estimated to be 3x higher or 74% higher per the FDA commissioned study.

The FDA held meetings on 12/8/11 to discuss the future of the pills and consider updated Warning Labels. Formal FDA action is pending and it is anticipated an upgraded Warning Label is forthcoming. This will mark the 3rd time the Warning Labels have changed in a 24month period after lawsuits began to be filed in 2009. The pills narrowly escaped a YAZ RECALL and more details are available here.

Dec. 16, 2011 at 3:02pm

CBSNews explores YAZ Birth Control Link to Blood Clots and notes risk of blood clots from DRSP (DROSPIRENONE) containing pills is higher. 

(Source: yazrecall.com)

More Detail on Risk Urged for Contraceptive Labels on YASMIN, YAZ #DRSP (DROSPIRENONE) pills

An advisory panel stopped short of recommending that the popular pills Yaz and Yasmin warn explicitly of a risk of blood clots.

NYTimes reports 21-5 vote for label change of #DRSP #DROSPIRENONE containing birth control. In narrower, 15-11 vote, panel concludes that benefits of pills outweigh risk.

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.

(Source: youtu.be)

10:52am

YAZ, YASMIN, DRSP (DROSPIRENONE) DANGEROUS? as seen on CNN 12.8.11

(Source: CNN)

FDA Revisits Safety of #DRSP #DROSPIRENONE Birth Control Drugs YAZ, YASMIN, BEYAZ & SAFYRAL - ABC News

12.8.11 FDA Advisory Committee hearings underway today to discuss elevated blood clot risk, side effects and other information pertaining to #DROSPIRENONE #DRSP containing birth control pills. Visit prior posts for more info.

12.6.11Canada’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

12.6.11
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