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.
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.
ABC Good Morning America, October 15, 2011, version of ABC NIGHTLINE Investigation of #DRSP #DROSPIRENONE Bitter Pill #YAZ and story of DRSP survivor C. Ubersox
FDA required corrective ads, or ‘clear up’, following FDA WARNING LETTERS involving DRSP (DROSPIRENONE) pills and their direct to consumer promotion.
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.
Concerns about an elevated risk of blood clots linked to certain birth-control pills will be discussed early next month by a Food and Drug Administration committee, which could recommend stronger warnings about potentially life-threatening problems.
At issue is the ingredient drospirenone, a form of progestin used in newer pills such as Yaz, Yasmin, Ocella, Safyral, Syeda, Zarah, Beyaz, Gianvi and Loryna.
In an effort to resolve conflicting results from previous research, an FDA-led study looked at 835,826 women and found a 74 percent higher incidence of clots for those who took the newer pills compared with those who took older types.
The risk of developing blood clots for all women who take birth-control pills is small overall: about 6 in 10,000, according to the FDA. The additional risk associated with the newer pills would put the number at about 10 in 10,000.
The analysis also found an elevated risk of heart attack and stroke for new users of the newer pills and an increased risk of clots in the legs or lung for women using a vaginal ring or birth-control patch.
On Dec. 8, the FDA committee will review the details of that study, after which they could recommend labeling changes.
The main concern is deep-vein thrombosis (a blood clot, usually in the lower leg or thigh) that breaks loose and leads to a pulmonary embolism, the potentially fatal blockage of an artery in the lung. Symptoms include persistent leg pain, severe chest pain and sudden shortness of breath.
Blood clots also can break loose and lead to strokes and heart attacks.
Emily Neffenger of Sunbury was looking forward to her June wedding when, two months before, she found herself in the bathroom in the middle of the night, unable to speak or open the door.
“The left half of my body was completely numb,” she said. “I sat down and didn’t know what to do. I couldn’t get out of the bathroom and I couldn’t talk. I was just kind of making noises.”
Alex, who is now her husband, found her there and called paramedics. Neffenger, 27, had had a mild stroke.
Eventually, doctors determined that Neffenger has a disorder that makes her prone to blood clots. But she also had been on Yaz, or a generic form, for several years.
Neffenger said doctors should be careful when prescribing birth-control pills and go over all the potential risks. She’d like to see routine testing for clotting problems.
Although blood tests are unlikely to become the norm, doctors can and should be careful to ask women about a family history of clotting and talk about other things that put women at higher risk, including smoking and obesity, said Dr. Geoffrey Eubank, a neurologist and director of Riverside Methodist Hospital’s stroke program.
In addition to learning about the risks associated with birth-control pills in general, women who have a known risk of clotting should have serious discussions with their doctors, he said.
“I think, like every decision, you kind of have to weigh the reasons you are using them against the risk,” he said.
Dr. Lisa Keder, associate professor of obstetrics and gynecology at Ohio State University Medical Center, said she has not been recommending against Yaz and similar pills because studies have shown mixed results and the risks overall are relatively low.
“If you double a rare thing, it’s still a rare thing,” she said.
And it’s important to remember that pregnancy carries an elevated risk of blood clots — about 30 incidents per 10,000 pregnant women — as well, she said.
Women who are concerned about their pills should not stop taking them without talking to their doctors, Keder said. Unintended pregnancy is a serious consideration when women who do not wish to have babies stop their birth control.
Women also should have educated discussions with their doctors about the best pill for them, Keder said. In general, she doesn’t think that Yaz and similar pills have an advantage over older pills.
Bayer, the maker of Yaz, has said that company leaders believe the clotting risks are similar to those associated with other birth-control pills and are working closely with the FDA to evaluate its study.
Full Story at Columbus Dispatch: