U.S. FDA Approves Second Bayer Oral Contraceptive That Also Raises Folate Levels

Bayer HealthCare Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive (OC), SAFYRAL™ (drospirenone 3 mg/ ethinyl estradiol 30 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets). In women who choose an OC for birth control, SAFYRAL raises folate levels for the purpose of reducing the risk of rare neural tube defects (NTDs) in a pregnancy conceived while taking SAFYRAL or shortly after discontinuing it. SAFYRAL provides the birth control YASMIN® (drospirenone 3 mg/ ethinyl estradiol 30 mcg) with 451 mcg levomefolate calcium, which is a B vitamin.


SAFYRAL is the second Bayer OC which contains folate. In September, the FDA approved Beyaz™ (drospirenone 3 mg/ ethinyl estradiol 20 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets), the first OC approved by the FDA to raise folate levels in women who choose an OC for birth control.


"With the FDA approval of Safyral, Bayer now offers two oral contraceptives that contain folate," said Leslie North, Vice President of Marketing, Women's HealthCare, Bayer HealthCare Pharmaceuticals. "SAFYRAL and Beyaz are part of Bayer's growing women's health franchise, and these new products reinforce our commitment to providing women various contraceptive options."


The Centers for Disease Control and Prevention, the U.S. Preventive Services Task Force, the March of Dimes and other leading health authorities recommend that all women of childbearing age supplement their diet with at least 400 mcg of folic acid daily.(1),(2),(3) A well-established body of evidence supports folate supplementation as a means to reduce the incidence of neural tube defects rare birth defects of the brain and spinal cord.(2),(3),(4) These rare birth defects happen in the first few weeks of pregnancy often before a woman finds out she is pregnant. As a result, daily folate supplementation is particularly important at least one month before and three months after conception.(2)


"Combining an oral contraceptive with folate is important, because women may become pregnant during OC use or shortly after discontinuation, possibly before seeking preconception counseling from their healthcare providers," said Dr. Anita Nelson, Professor of Obstetrics and Gynecology at the Harbor-UCLA Medical Center, Torrance, California. "For women who already use YASMIN for contraception, SAFYRAL offers these women a new option to receive daily folate supplementation as part of their OC routine."


Women should not use SAFYRAL if they smoke and are over age 35. Smoking increases the risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke or heart attack. This risk increases with age and number of cigarettes smoked.















Patients are advised to alert their healthcare provider if they are taking folate supplements. SAFYRAL is not indicated during pregnancy. SAFYRAL has 99 percent contraceptive efficacy when used as directed. If pregnancy occurs during treatment with SAFYRAL, further intake must be stopped. If a woman discontinues use of SAFYRAL either with the intention of becoming pregnant or if she discontinues due to pregnancy while on the product, she is strongly encouraged to speak with her healthcare provider about taking a multivitamin with folic acid or another folate to maintain recommended folate intake.


SAFYRAL is in a 21/7 day regimen consisting of 21 days of drospirenone 3 mg/ethinyl estradiol 30 mcg with levomefolate calcium 451 mcg (Metafolin®*) followed by seven days of Metafolin only. SAFYRAL is expected to be available in mid-January 2011 by prescription only.


Women should not use SAFYRAL if they have kidney, liver, or adrenal disease because this could cause serious heart and health problems, or if they have or have had blood clots, certain cancers, history of heart attack or stroke, or if they are or may be pregnant. SAFYRAL increases the risk of serious conditions including blood clots, stroke and heart attack. Smoking increases these risks, especially in women over 35. The risk of blood clots is highest during the first year of use.


In addition, SAFYRAL contains drospirenone, a different kind of hormone that for some may increase potassium too much. Women should consult with their healthcare provider if they are on daily long-term treatment for a chronic condition with medications that may also increase potassium, as they should have a blood test to check their potassium level during the first month of taking SAFYRAL.


About the Clinical Development Program for SAFYRAL


The FDA approval of SAFYRAL to raise folate levels in women who choose an OC for contraception is based on two clinical trials. The first trial was a pivotal 24-week clinical trial involving 379 healthy women aged 18-40 years, which found that YAZ® (drospirenone 3 mg/ ethinyl estradiol 20 mcg) in combination with 451 mcg of Metafolin increased folate levels from baseline. This multicenter, randomized, double-blind, parallel group study conducted in a U.S. population with folate fortified food evaluated the effect of YAZ in combination with 451 mcg of Metafolin on red blood cell (RBC) folate and plasma folate levels compared to YAZ alone during 24 weeks of treatment. At week 24, the mean changes from baseline were significantly (p

Giuliani Says He Would Appoint 'Strict Constructionist' Judges To Supreme Court

Former New York City Mayor and possible Republican presidential candidate Rudolph Giuliani in recent weeks has "distanc[ed] himself from a position favoring abortion rights that he espoused" during his mayoral campaigns and "highlighted a different element of his thinking on the abortion debate," the New York Times reports. Giuliani in recent talks with conservative media outlets and voters in South Carolina said he would appoint "strict constructionist" judges to the Supreme Court -- a term that abortion-rights advocates say is "code among conservatives for those who seek to overturn or limit" Roe v. Wade, the 1973 Supreme Court decision that effectively barred state abortion bans -- the Times reports. Giuliani said he would nominate judges like Chief Justice John Roberts and Justices Antonin Scalia and Samuel Alito, who he believes would restrict Roe. In a recent interview with Sean Hannity of Fox News, Giuliani said that a law (S 3) being reviewed by the Supreme Court that bans so-called "partial-birth abortion" should be upheld. Giuliani in 2000 when asked by NBC News' "Meet the Press" host Tim Russert if he supported President Clinton's veto of a law that would have banned partial-birth abortion said, "I would vote to preserve the option for women. I think the better thing for America to do is to leave that choice to the woman because it affects her probably more than anyone else." Giuliani also told Hannity that he supports parental notification requirements for minors seeking abortion with a judicial bypass provision. On a 1997 candidate questionnaire from the National Abortion and Reproductive Rights Action League of New York he answered "yes" to the question: Would you oppose legislation "requiring a minor to obtain permission from a parent or from a court before obtaining an abortion." Giuliani's campaign aides say that he has not changed his position on abortion and that his stance on partial-birth abortion has been mischaracterized. "[A]bortion is something that, as a personal matter, I would advise somebody against," Giuliani said during the Hannity interview, adding, "I believe in a woman's right to choose. I think you have to ultimately not put a woman in jail for that" (Rivera, New York Times, 2/10).

Romney Comments on Abortion Rights
Possible Republican presidential candidate and former Massachusetts Gov. Mitt Romney on Friday during a visit to South Carolina "sought to dispel doubts" about his views against abortion rights, the AP/Boston Globe reports. "I am firmly pro-life," Romney told about 100 Republicans at a local restaurant, adding, "Every act I've taken as governor has been in favor of life," (Davenport, AP/Boston Globe, 2/9). Since Romney first ran for U.S. Senate in 1994, he has acknowledged that his position on abortion has changed from "proudly" supporting abortion rights to saying that he would "like to see" Roe overturned. When Romney ran for governor in 2002, he promised to "preserve the status quo" on abortion rights in the state and oppose any changes to state laws that restricted or increased access to abortion. However, Romney in 2004 said when he studied human embryonic stem cell research, he experienced an "awakening that led him to the conclusion that 'the sanctity of life had been cheapened' by the Roe decision" (Kaiser Daily Women's Health Policy Report, 12/21/06). According to the AP/Globe, abortion is a major issue among South Carolina's conservative voters (AP/Boston Globe, 2/9).

Opinion Piece
Romney, Giuliani and other political candidates might be "thoroughly sincere in rethinking their old positions" on abortion and other issues, but they also are part of a political system that "has created strong incentives for candidates to be less than candid about what they really think," Washington Post columnist E.J. Dionne writes in an opinion piece. Candidates are "rarely willing to say ... that they do not consider abortion the most important issue in politics," and "we don't make it easy" for them to "admit, as most voters do, that abortion is an agonizing question," according to Dionne. Giuliani's support for abortion rights will test whether presidential candidates have to "hold to each party's version of political correctness" in regard to abortion rights in order to receive primary votes, Dionne writes. He concludes that "we have created a system" that encourages many politicians "to adjust their convictions to their political needs," adding, "And then we denounce them" (Dionne, Washington Post, 2/13).

Broadcast Coverage
In an interview on ABC's "This Week," Arkansas Gov. Mike Huckabee (R) -- who is seeking the Republican presidential nomination -- addressed Giuliani's position on abortion rights and other issues. In response to a question about whether Giuliani's position on abortion rights would be "a game-ender in the Republican primaries," Huckabee said, "We'll find out in this election, it looks like, because it's going to be an issue that will clearly separate some of the candidates." He added, "But I'm pro-life because I think it's consistent with who we are as an American people. We are a culture and civilization that celebrates life" (Stephanopoulos, "This Week," ABC, 2/11). Video and a transcript of the segment are available online.














NPR's "Morning Edition" on Tuesday reported Romney's potential presidential campaign. Romney's past positions on abortion and other issues could negatively affect his support among social conservatives, NPR reports (Inskeep/Gonyea, "Morning Edition," NPR, 2/13). Audio of the segment is available online.

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Fractures Significantly Reduce Quality Of Life In Women With Osteoporosis

Researchers seeking to understand the impact of osteoporosis and fractures on various aspects of health have found that women who had previous fractures experienced a significant reduction in health-related quality of life similar to or worse than that experienced by patients with diabetes, arthritis, lung disease and other chronic illnesses. This latest study from the Global Longitudinal Study of Osteoporosis in Women (GLOW), which is based at the Center for Outcomes Research at the University of Massachusetts Medical School, was published online in the Mayo Clinic Proceedings.



Approximately 40 percent of women over 50 will suffer a fracture; the most common sites of fracture are the hip, spine and wrist. These fractures often carry with them chronic pain, reduced mobility, loss of independence, and especially in the case of hip fracture, an increased risk of death. Because the likelihood of fractures increases substantially with older age, fracture numbers are projected to rise as the population ages.



Using a standardized index measuring five dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), the study authors administered health surveys to nearly 60,000 postmenopausal women in 10 countries. The surveys were used to compare the overall health status, physical function and vitality of participants and assess health-related quality of life. The study found that spine, hip and upper leg fractures resulted in the greatest decrease in quality of life.



"Our study shows that the effects of fractures result in significant reductions in quality of life that are as lasting and as disabling as other chronic conditions. As important, the greater the number of fractures, the greater the disability," said the lead author of the paper, Jonathan D. Adachi, MD, GLOW investigator and the Alliance for Better Bone Health Chair in Rheumatology at St. Joseph's Healthcare and McMaster University in Ontario. "This suggests that efforts are needed to prevent fractures from occurring."



Study Details:


GLOW is a prospective, international cohort study of women 55 years of age and older who visited their primary care physician during the 2 years prior to enrollment in the study. Over 60,000 women were recruited by more than 700 primary care physicians in 17 cities in 10 countries (Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom and United States). In GLOW, information is being gathered on fracture risk factors, treatments, patient behaviors, and fracture outcomes over a 5-year period.



GLOW in Worcester, Massachusetts:


28,000 US women are participating in GLOW. Dr. Stephen Gehlbach from the School of Public Health and Health Sciences, University of Massachusetts and co author of the article enrolled 5,091 women through the University of Massachusetts Memorial Health Care system and area physician practices. Of these participants, 23% had a previous fracture.



Sponsors:


Financial support for the GLOW study is provided by Warner Chilcott Company, LLC and sanofi-aventis to the Center for Outcomes Research, University of Massachusetts Medical School.



Source:

Alison Duffy

University of Massachusetts Medical School

Minster Unveils 'Linda's Pregnancy' at Maternity Conference, UK

UK Health Minister Stephen Ladyman will today announce an Exemplar
showing a woman's journey through pregnancy and birth and
illustrating how Government standards can be put into practice to
provide greater choice and flexibility for women using maternity
services.


'Linda's pregnancy' follows the journey of a young African Caribbean
woman and her partner as they progress through her second pregnancy.
Covering issues such as smoking during pregnancy, healthy eating and
concerns over maternal mental health, the story is taken from Linda's
realisation that she is pregnant through to 6 weeks after the birth
of her child.


Health Minister Stephen Ladyman said


"Maternity services already represent one of the many success stories
of the NHS and the exemplar illustrates some of the ways in which
professionals can work together to place the needs of women and their
babies at the centre of their care using the Children's and Maternity
National Service Framework (NSF).


"The NSF will encourage choice in maternity services so that,
whenever possible, women can decide where they give birth and the
type of care they receive. I am pleased to be working with our
partners at the Royal Colleges to take this work forward."


The Exemplar will be unveiled at 'Maternity Services for the 21st
Century', a conference which is a collaboration between the
Department of Health, the Royal College of Obstetricians and
Gynaecologists, the Royal College of Paediatrics and Child Health and
the Royal College of Midwives. It will focus on professionals
working in partnership to achieve the best outcomes and experiences
for women using maternity services.


The Royal College of Obstetricians & Gynaecologists said
"Today is all about teamwork to support one another in the
implementation of the National Service Framework and to find the best
way forward so that we can all make real and lasting improvements for
women and their babies.


"It is important to remember that this is a ten year plan for
improving care and the Colleges will now encourage the dissemination
of the Framework down to a local level so that it can be implemented
to best support the needs of local populations.


"The RCOG looks forward to continuing our close working relationship
with our colleagues at the Royal College of Midwives and the Royal
College of Paediatrics and Child Health in using this Framework to
deliver high quality maternity and neonatal services to all women in
England and Wales. The College believes that the multi-disciplinary
approach emphasised in the Framework will give us a real opportunity
to change and improve maternity services over the next decade."


The Royal College of Midwives said


"Today provides us all with the opportunity to discuss the first
steps in implementing the new NSF. We look forward to working with
our partners in providing maternity services that are user led, with
an emphasis on fulfilling health and social care needs and
priorities, as we move into the 21st Century."


Achieving the standards set out in the NSF will be challenging and in
recognition of this it has been developed as a ten-year strategy,
with services expected to meet the standards by 2014.


The NSF presents a real opportunity for the NHS to target resources
more effectively and utilising new ways of working. It aims to
ensure that Primary Care Trusts and maternity service providers
design, review and improve maternity services through a programme of
consultation, building on the work of existing local groups.



'Maternity Services for the 21st Century' will be held on 14 March
2005 at the Royal College of Obstetricians and Gynaecologists, London


The Maternity services exemplar can be found at

dh/assetRoot/04/10/60/49/04106049


The National Framework for children, young people and maternity
services was published on 15th September 2004 and is the biggest
national initiative to improve health and social services and can be
found
if you CLICK HERE.


For media enquiries, please contact: Michelle Hinds at the Department
of Health Media Centre on tel: 020 7210 5375, Marie Sterry at the
Royal College of Obstetricians and Gynaecologists on 0207 772 6357 or
Jonathan Andrews at the Royal College of Midwives on 0207 312 3432


For public enquiries, please contact the Department of Health Public
Enquiries Department on tel: 020 7210 4850


GNNREF: 112523

Issued by : DOH Press Office

Proponents Of Female Genital Cutting In Kenya Promoting It As HIV Prevention Method

Some proponents of female genital cutting in Kisii, Kenya, are claiming that the practice will reduce a woman's risk of contracting HIV, IRIN/PlusNews reports. These proponents say FGC prevents HIV because women will have reduced sexual desire after it is performed, resulting in fewer sexual partners and a decreased risk for contracting the virus. Researchers have challenged the notion that there is a difference sexual desire among women who have undergone FGC with those who have not, IRIN/PlusNews reports. After FGC was outlawed for girls younger than age 18, local residents say that proponents of the procedure have become "even more aggressive in their efforts to keep [FGC] alive." Jacqueline Mogaka, a local advocate against FGC, said, "I do not know where this idea of female genital mutilation being a remedy for HIV infection originated, but it is a strong belief" in Kisii, adding, "Young girls are now even voluntarily turning up for the cut because of this belief."

Despite being against Ministry of Health policy, FGC still is widespread in Kisii, with 97% of girls undergoing the procedure, most commonly when they are teenagers, IRIN/PlusNews reports. Grace Kemunto, a traditional circumciser said, "When you are cut as a woman, you do not become promiscuous and it means you cannot get infected by HIV." Opponents of FGC say the assumption that women and girls are always in control of their sexual practices is false and can be harmful, according to IRIN/PlusNews. In the Nyanza province, where Kisii is located, an estimated 9% of girls are married by age 15, and 53% are married by age 19, according to data from a 2003 Kenya Demographic and Health Survey. IRIN/PlusNews reports that efforts against FGC pointed out the increased HIV risk with traditional methods such as a single cutting device used on multiple women. However, this lead to an increase in nurses and midwives performing the procedure, which opponents indicate is "holding back the fight against FGC because the practice was no longer associated with a fear of HIV," IRIN/PlusNews reports. The practice also poses a risk of hemorrhaging -- during the procedure or childbirth, as well as from vaginal tearing during sexual intercourse -- that could lead to a need for blood transfusions in regions where a safe blood supply is not guaranteed, according to IRIN/PlusNews (IRIN/PlusNews, 1/27).


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Women's Risk Of Developing Schizophrenia Increased By Genetic Variant

A complete scan of the human genome has revealed that a genetic variant in the Reelin gene increases the risk of developing schizophrenia in women only. Researchers from the Hebrew University of Jerusalem and the University of Oxford, who conducted the study in the Ashkenazi Jewish population, confirmed their findings by establishing a multinational collaboration that included populations and researchers from the United Kingdom, Ireland, United States, and China. Their research is published in the February issue of the open-access journal PLoS Genetics.



Heritability of schizophrenia has been well established through epidemiological studies in past years. However, efforts to identify the genes associated with this devastating disease, which affects about 1% of the human population, have encountered significant difficulties. Technological advances that allow the complete and efficient scanning of the entire genome present a new opportunity to address this challenge.



The authors analyzed 500,000 genetic variants distributed across the whole human genome in DNA from patients with schizophrenia and control subjects. By comparing the genomes of hundreds of patients with schizophrenia with those of healthy controls across several human populations, the researchers identified a gene that significantly increases the risk of developing the disease, but interestingly in women only.



This study represents significant progress in the study of schizophrenia with possible practical implications in the areas of disease diagnosis and drug discovery. Nevertheless, it is important to stress that these possibilities will require many years of additional research, and even then, success cannot be guaranteed.







Link to the published article



CITATION: Shifman S, Johannesson M, Bronstein M, Chen SX, Collier DA, et al. (2008) Genome-wide association identifies a common variant in the reelin gene that increases the risk of schizophrenia only in women. PLoS Genet 4(2): e28. doi:10.1371/journal.pgen.0040028



CONTACT:


Dr. Sagiv Shifman

University of Oxford

Wellcome Trust Centre for Human Genetics


Dr. Ariel Darvasi

Hebrew University

Center for Research on Pain



Disclaimer


This press release refers to an upcoming article in PLoS Genetics. The release is provided by the article authors and/or their institutions. Any opinions expressed in this release or article are the personal views of the journal staff and/or article contributors, and do not necessarily represent the views or policies of PLoS. PLoS expressly disclaims any and all warranties and liability in connection with the information found in the releases and articles and your use of such information.



About PLoS Genetics


PLoS Genetics (plosgenetics/) reflects the full breadth and interdisciplinary nature of genetics and genomics research by publishing outstanding original contributions in all areas of biology. All works published in PLoS Genetics are open access. Everything is immediately and freely available online throughout the world subject only to the condition that the original authorship and source are properly attributed. Copyright is retained by the authors. The Public Library of Science uses the Creative Commons Attribution License.



About the Public Library of Science


The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit plos/.



Source: Mary Kohut


Public Library of Science

Study Finds Health Care Disparities For Female Veterans

Female veterans do not receive the same quality of outpatient care as male veterans at about one-third of the 139 Department of Veterans Affairs facilities that offer it, according to a report released on Friday by VA, the AP/Philadelphia Inquirer reports. Women account for about 14% of the U.S. Armed Forces and about 5% of VA's population, but that number is expected to nearly double in the next two years. The VA's review found the health care disparity even as women are serving on the front lines at historic levels.

The review found a need for more physicians trained to address the health care needs of women, as well as more equipment for women's health. The report noted that other studies had found better surgical outcomes and decreased mortality for women at VA hospitals compared with women enrolled in Medicare Advantage plans or those receiving private care. Other studies also have shown better performance of breast and cervical cancer screenings among women receiving care through VA than those enrolled in private or other government-sponsored health plans.

William Duncan, associate deputy undersecretary at VA, said the disparity between men and women's health is unacceptable and the department is working to address the issue. He said, "We're striving to understand the reason for these health disparities in veterans health care based on personal characteristics." The report states that VA has made some progress, such as creating on-site mammography services and women's clinics at most VA facilities. VA also is trying to recruit more clinicians with training in women's care, according to the report (Hefling, AP/Philadelphia Inquirer, 6/16).


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.