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.

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