In “MOM WARNS BIRTH CONTROL KILLED HER DAUGHTER”, ABC 7 WXYZ.COM, DETROIT, MI, reports on the recent funeral of S. Burns. The 25 year old died and was buried on Mother’s Day 2012, following an aneurysm. In the heart breaking video above, her surviving Mother, Natalie Rogers, explains that YAZ “was the only medication she was on” and that she believed she died from taking the #DROSPIRENONE (#DRSP) containing contraceptive.
(Source: yazrecall.com)
“Blood Clot Warning Added to Yaz and Other Newer Birth Control Pills
April 11, 2012 | By Alexandra Sifferlin | 1
Harrison Eastwood / Getty Images
Yaz, Yasmin and other newer birth control pills will soon be bearing warning labels that detail the potential risk of blood clot risks, the U.S. Food and Drug Administration (FDA) announced on Tuesday.
The FDA is updating the labels based on recent studies that suggest that birth control pills containing drospirenone, a synthetic version of the female hormone progesterone, have a slightly increased risk of blood clots, compared with older birth control pills.
(MORE: Caution Ladies: More Birth Control Pills Recalled)
The new labels will note that some studies have found as high as a threefold increase in the risk of blood clots with drospirenone-containing pills, and will include a summary of a previous FDA-funded study on the risk, officials said in a statement.
However, the overall risk of blood clots on either newer or older birth control pills is still very low. In its statement, the FDA put the risk 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…For example: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot.
Popular birth control brands Beyaz, Safyral, Yasmin and Yaz will all receive the updated labels, but the FDA says women already using them shouldn’t worry and should “continue taking their pills as directed unless told otherwise by their healthcare professional.”
(VIDEO: Nancy Gibbs on the Pill’s Importance)
The FDA does suggest that women educate themselves on symptoms of blood clots, including persistent leg pain, severe chest pain and sudden shortness of breath. If women experience these symptoms, they should call their doctor right away.”
http://healthland.time.com/2012/04/11/blood-clot-warning-added-to-yaz-and-other-newer-birth-control-pills/
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/
February 28, 2012
”Women Warned Over Popular Birth Control Medication” by Sandra Chapman, of Indianapolis, 13, WTHR.COM, explores the history of DRSP (DROSPIRENONE) containing birth control pills and the claim of one woman who suffered a DVT (Deep Vein Thrombosis). As previously reported on this blog, DRSP LAWSUITS, or DROSPIRENONE LAWSUITS continue to exceed 11,000 as of February 2012. The story does not address the December 8, 2011 Advisory Committee vote that found the warnings were inadequate and do not (even as of this writing) communicate the elevated risks of blood clots associated with #DRSP #DROSPIRENONE containing birth control pills. Additional information on that subject is available at DRSPRecall.
INDIANAPOLIS -
It was one the best selling birth control pills on the market. But now, a warning for women.
Fifty patients have reportedly died from taking the contraceptive and thousands of others say it causes potentially life-threatening side effects, prompting a trusted drug maker to spend millions to highlight the risks.
Linda Rosenberg was the picture of a healthy baby. She recalls growing up on Bayer Baby Aspirin and planned to care for her own baby in the same way, someday.
In 2007, motherhood was still in the future when her doctor told her about Yaz, a new oral contraceptive manufactured by Bayer. It was sweeping the country with a flashy ad campaign.
“There was no reason to believe the product was, you know, that there was any danger in taking it,” explained Rosenberg.
But two years after taking daily doses of Yaz, Linda began experiencing unexplainable swelling. At her doctor’s urging, she got an ultrasound. It probably saved her life. A blood clot was discovered in her ankle.
“Yes and right behind my knee, which was causing the swelling in the ankle,” she told 13 Investigates.
Linda went through 18 months of treatment. But along the way, she lost more than she could have imagined.
“Now, I can’t have children,” she revealed.
The treatment for the blood clot left her unable to conceive children and her trust in a childhood name was gone. Rosenberg is now among hundreds of women nationwide blaming Bayer’s Yaz birth control for devastating health effects.
“I’d like to see it off the shelves, if it’s not safe,” Linda insists.
“It doesn’t happen just with Yaz,” according Dr. Sara Sayger.
Sayger has prescribed Yaz as the medical director at the Purdue Health Center and Women’s Clinic in West Lafayette. In fact, Sayger concludes all oral contraceptives come with some risk.
“Blood clotting is an uncommon side effect. A real danger, but an uncommon side effect,” she said.
But according to lawsuits nationwide, Yaz is being blamed for the deaths of at least 50 women, including young college students.
Dr. Sayger confirms the new ingredient.
“We’ve seen a couple of new synthetic progesterones that have come onto the market. Yaz is one of those new synthetic progesterones,” she said. Sayger describes Yaz as a “niche” contraceptive and evaluates closely whether it’s a good fit for each patient. “It’s a pill that’s been very positively received by women who have been on other products and still had very extreme emotional, premenstrual mood swings. Yaz seemed to be a good answer for those people” she found in her practice. But Sayger agrees it’s not for everyone. In 2008, the FDA sent Bayer a warning letter regarding its advertising for Yaz. The FDA took issue with claims by Yaz to treat PMS and acne of all severities, even though Yaz had not been evaluated to do such. The FDA also said “Yaz has additional risks because it contains the progestin, Drospirenone…which may result in potentially serious heart and health problems” in high risk patients. The FDA said Bayer knew about the risks, the information came from the company’s own studies. Yet it’s warning labels failed to adequately disclose the potential danger. Bayer declined an on-camera interview with 13 Investigates about Yaz, but in a released statement said “..the benefits…outweigh the potential risks” and that “labels…do not adequately reflect the risk…and should be revised to include additional information from available studies.” Bayer is now airing corrective ads. Sayger points out that the FDA shares responsibility to ensure products for women are safe and wants to see more studies. “Birth control pills have been on the market for 50-plus years. We now have three or four generations of pill users, so we have lots of experience with birth control pills,” Sayger said. But it’s too late for Linda Rosenberg. “Had I known that it could have been an issue, or a problem, I certainly would have not chosen to go that route,” she said, hoping to warn other women. The FDA did not take Yaz off the market. Sayger says fewer college students are using that contraceptive, but for other reasons. She says Yaz costs around $70 a month, compared to other brands that range from $9 to $20. Bayer is facing 10,000 lawsuits surrounding its Yaz and Yasmin birth control.
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.
NBC Nightly News with Brian Williams explores #DRSP (#DROSPIRENONE) containing birth control pills on 12.8.11, following FDA Advisory Committee Hearings evaluating the elevated, and confirmed, risk of blood clots per FDA funded study.
(Source: yazrecall.com)
YAZ, YASMIN, DRSP (DROSPIRENONE) DANGEROUS? as seen on CNN 12.8.11
(Source: CNN)
