FDA links new blood clots birth control drugs

WASHINGTON (AP) - concerns of security with the popular birth control pill as yaz increased federal Thursday that scientists of Health reported that the drug from Bayer and other newer birth control treatment appear to increase the risk of dangerous blood clots more older drugs.

A new study published by the Food and Drug Administration reviewed the medical history over 800,000 women U.S. takes different forms of control of births between 2001 and 2007. On average, women taking Yaz had 75% more likely to end up with a blood clot than women older birth control medications.

YAZ contains estrogen with a synthetic hormone of next generation called drospirenone, who is known to increase the level of potassium in the blood. FDA compared the medical records of women taking the drug with those who take the old drug levonorgestrel.

YAZ, Yasmin and related pills containing drospirenone of were free of second-best-selling Bayer to $ 1.6 billion in global sales last year.

In 2009, the FDA has taken an unusual step order Bayer to run corrective on Yaz TV advertisements, stating that the ability of drugs exaggerated the drugmaker marketing campaign to prevent acne and premenstrual syndrome.

Bayer Healthcare, a division of the German conglomerate, it says "currently assessing this publication and cannot comment on at this time."

The Agency also reported complications higher in women using the Ortho Evra of Johnson & Johnson and ring patch vaginal Nuvaring of Merck & Co. Inc. These drugs combine estrogen, which is present in all birth control pills, with two other synthetic hormones in the last decade.

The FDA said it has not reached a final conclusion on the safety of the drugs but will hold a meeting with scientific advisors on 8 December.

The consumer safety advocates have criticized the Agency of the latest and most expensive birth control drug approval when cheaper, generic medicines with established security records are widely available.

"At some point we must ask why the FDA continues to approve drugs that are less safe and have no advantage over drugs already on the market," said Dr. Diana Zuckerman, President of the National Centre for women and families, a group of consumers for women's health issues. "With all these different birth control options, why take the more expensive that can kill you?"

Recent studies have reached different conclusions about the risks of contraceptive pills more recent.

A study published earlier this week on more than 1 million Danish women found that women taking Yaz and other newer drugs have twice the risk of blood clots as women taking the hormone levonorgestrel older. The findings published Tuesday in the British Medical Journal.

However, two studies published in 2007, conducted as part of the regulators FDA postmarketing requirements or European, have not found any difference in clotting between comparable groups.

Pills of birth control containing drospirenone include Yaz, Yasmin, Bayer's Beyaz, Safyral; Sandoz Syeda and Loryna; as well as Ocella Barr, Watson Pharmaceuticals Zarah and Loryna of Teva Pharmaceuticals laboratories.

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Using one embryo in IVF doesn't cut birth rate

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By Genevra Pittman

NEW YORK | Fri Oct 21, 2011 5:24pm EDT

NEW YORK (Reuters Health) - A new study from an Iowa fertility center found that implanting women with one embryo during in vitro fertilization (IVF) didn't lower their chances of having a baby, but it did mean fewer women gave birth to twins.

IVF has traditionally involved implanting multiple embryos, which is known to increase by many times a woman's chances of having twins. Pregnancy with multiples raises certain risks to both moms and babies, including diabetes during pregnancy, premature birth and cerebral palsy.

Dr. Jessica Kresowik from the University of Iowa in Iowa City said she and her colleagues felt that twin rates at their clinic were too high -- so they began requiring that younger women with a good chance of getting pregnant only have one embryo implanted.

The goal was to "increase the outcome that we want, of one healthy baby at a time," she told Reuters Health.

Babies conceived through IVF account for just one percent of U.S. births each year, but IVF is responsible for 17 percent of twins, Kresowik and her colleagues write in the journal Fertility and Sterility.

According to the American Society for Reproductive Medicine, no more than two embryos should be implanted in women under 35 -- and doctors should consider using just one.

But in the U.S., those guidelines have been "slowly adopted," the researchers note, with many clinics still implanting multiple embryos in younger, healthy women.

"In the past, you did need to implant multiple embryos in order to maintain those pregnancy rates," Kresowik said, adding that before technology improved, doctors might use six embryos at once, hoping that one would result in a pregnancy.

Now, she said, more centers are offering single embryos as an option to patients.

Using a single embryo for all women under 38 who were getting their first round of IVF and had other signs predicting a good outcome became the policy at Kresowik's fertility clinic in 2004.

The researchers collected data on IVF outcomes from five years before and five years after that practice started. As it turned out, birth rates at the clinic didn't suffer because of the policy -- in fact, they improved over time.

Before the single-embryo policy, 51 percent of all women younger than 38 got pregnant and gave birth to a live baby, compared to 56 percent afterwards.

And the proportion of women with births of multiples dropped from 35 percent to less than 18 percent when the policy was in place.

Among 364 women who fit the criteria and had a single-embryo transfer from 2004 on, 65 percent gave birth to a live baby and just over three percent had twins or other multiples.

Kresowik said that the study can "serve as a model" to other fertility clinics that want to lower their twin rates.

"A policy like this is a great idea," said Judy Stern, a fertility specialist at the Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, who wasn't involved in the new study.

The findings, she told Reuters Health, show that "it can work. You really can move toward single-embryo transfer and have it give you great success rates, and really low multiple rates."

Dr. Nicole Noyes, from the New York University Fertility Center, said that her team has also seen success using single-embryo transfer in ideal cases.

If doctors find good-quality embryos, she told Reuters Health, "and you have a good prognosis patient, putting a single embryo in does not lower pregnancy rates."

Another important finding, Kresowik said, was that the clinic didn't have any fewer women seeking treatment after the policy was implemented. Some women hope for twins during IVF, she said, seeing it as "an efficient way to reproduce" if they aren't fully aware of the risks involved -- but they didn't seem to flock away.

"If your practitioner's telling you, 'I think you should only have one embryo implanted,' that's a good thing," she concluded.

SOURCE: bit.ly/qjjdpu Fertility and Sterility, online September 29, 2011.

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Using one embryo in IVF doesn't cut birth rate

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By Genevra Pittman

NEW YORK | Fri Oct 21, 2011 5:24pm EDT

NEW YORK (Reuters Health) - A new study from an Iowa fertility center found that implanting women with one embryo during in vitro fertilization (IVF) didn't lower their chances of having a baby, but it did mean fewer women gave birth to twins.

IVF has traditionally involved implanting multiple embryos, which is known to increase by many times a woman's chances of having twins. Pregnancy with multiples raises certain risks to both moms and babies, including diabetes during pregnancy, premature birth and cerebral palsy.

Dr. Jessica Kresowik from the University of Iowa in Iowa City said she and her colleagues felt that twin rates at their clinic were too high -- so they began requiring that younger women with a good chance of getting pregnant only have one embryo implanted.

The goal was to "increase the outcome that we want, of one healthy baby at a time," she told Reuters Health.

Babies conceived through IVF account for just one percent of U.S. births each year, but IVF is responsible for 17 percent of twins, Kresowik and her colleagues write in the journal Fertility and Sterility.

According to the American Society for Reproductive Medicine, no more than two embryos should be implanted in women under 35 -- and doctors should consider using just one.

But in the U.S., those guidelines have been "slowly adopted," the researchers note, with many clinics still implanting multiple embryos in younger, healthy women.

"In the past, you did need to implant multiple embryos in order to maintain those pregnancy rates," Kresowik said, adding that before technology improved, doctors might use six embryos at once, hoping that one would result in a pregnancy.

Now, she said, more centers are offering single embryos as an option to patients.

Using a single embryo for all women under 38 who were getting their first round of IVF and had other signs predicting a good outcome became the policy at Kresowik's fertility clinic in 2004.

The researchers collected data on IVF outcomes from five years before and five years after that practice started. As it turned out, birth rates at the clinic didn't suffer because of the policy -- in fact, they improved over time.

Before the single-embryo policy, 51 percent of all women younger than 38 got pregnant and gave birth to a live baby, compared to 56 percent afterwards.

And the proportion of women with births of multiples dropped from 35 percent to less than 18 percent when the policy was in place.

Among 364 women who fit the criteria and had a single-embryo transfer from 2004 on, 65 percent gave birth to a live baby and just over three percent had twins or other multiples.

Kresowik said that the study can "serve as a model" to other fertility clinics that want to lower their twin rates.

"A policy like this is a great idea," said Judy Stern, a fertility specialist at the Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, who wasn't involved in the new study.

The findings, she told Reuters Health, show that "it can work. You really can move toward single-embryo transfer and have it give you great success rates, and really low multiple rates."

Dr. Nicole Noyes, from the New York University Fertility Center, said that her team has also seen success using single-embryo transfer in ideal cases.

If doctors find good-quality embryos, she told Reuters Health, "and you have a good prognosis patient, putting a single embryo in does not lower pregnancy rates."

Another important finding, Kresowik said, was that the clinic didn't have any fewer women seeking treatment after the policy was implemented. Some women hope for twins during IVF, she said, seeing it as "an efficient way to reproduce" if they aren't fully aware of the risks involved -- but they didn't seem to flock away.

"If your practitioner's telling you, 'I think you should only have one embryo implanted,' that's a good thing," she concluded.

SOURCE: bit.ly/qjjdpu Fertility and Sterility, online September 29, 2011.

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Woman gives birth after marathon

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11 October 2011 Last updated at 01:28 GMT Amber Miller said she was happy but called it the "longest day of my life" after giving birth to a daughter following completing the Chicago Marathon

Instead of having a rest after completing the Chicago Marathon, pregnant Amber Miller gave birth.

Mrs Miller, who was nearly 39 weeks pregnant, said "it was the longest day of my life". She gave birth to a healthy 7.7lb (3.5kg) girl, June.

The marathon was the eighth for the 27-year-old, who already had one child. On her doctor's orders she ran half and walked half the distance.

"Lots of people were cheering me on: 'Go pregnant lady'," she said.

"For me, it wasn't anything out of the ordinary. I was running up until that point anyway," she told Associated Press news agency.

"I am crazy about running."

Because she half-walked the race, she finished the 26.2 mile (42.16km) course in 6:25 - slower than her usual pace.

"A few minutes after finishing, the contractions became stronger than normal and I understood what was going on," she said.

"When they became more regular, we had a sandwich and then we left for hospital," Mrs Miller added.

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Brooklyn Artist to Give Birth in Public, as Performance Art

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Birth is both intensely private and unnervingly public, as nurses and doctors march in and out of a woman's hospital room, poking, prying, checking. There can be — shhh — poop involved. And, of course, the vagina — which most women have spent their lives covering up — plays a starring role.

Now comes Marni Kotak, who intends to elevate the private-public dichotomy to a new level, giving birth to her first child in Brooklyn. In an art gallery. Where you can watch.

"...By giving birth in public, I can bring to light something that our society clearly has many issues surrounding," wrote Kotak in an e-mail. "It troubles me when I hear women speak disdainfully about their own bodies, especially when it involves birth, as that is truly women's greatest power."

At Microscope Gallery, the stage is quite literally set for what the gallery's website calls a "durational performance culminating in an actual birth." Kotak, 36 and eight months pregnant, has fashioned a cozy birthing nook, anchored by her grandmother's bed and rocking chair and a birthing tub. A midwife and doula will assist Kotak, and there's a hospital right down the road, just in case.

MORE: In Pittsburgh, Public Art Doubles as a Sanctuary for Breast-Feeding Moms

To clarify, Kotak's labor and delivery won't be a free-for-all. "It will be a small group of people that have all come out to the gallery and spent some time getting to know me and talking to me about the exhibit," wrote Kotak. "It is important for me that I and my support team are comfortable with all of the people who will be in the audience so that I have the best birth experience for the health of the baby, myself and everyone present."

It's unclear when Kotak is actually due, but she's given herself a one-month window of time; "The Birth of Baby X" is set to run from Oct. 8 to Nov. 7. Until labor kicks in, Kotak will flit in and out of the gallery, psyching herself up for "her most profound and physically challenging performance" yet. That's saying a lot, considering Kotak's previous performances: her own birth, being forced to wear a dunce cap on a third-grade field trip and the act of losing her virginity in a blue Plymouth.

"The Birth of Baby X," incidentally, is just Act One. Kotak intends to track her child's development in an installation entitled "Raising Baby X" that "re-contextualizes the everyday act of raising a child into a work of performance art..."

Kotak, who has been overwhelmed by media interest in her project, emphasizes that she's just an artist with a job to do, which, according to the gallery's website, is to "avoid the spectacle often involved in performance art to reach what is real."

Birth is real, for sure. Real painful. Real unpredictable. Real messy. Almost surreal, in fact, while I watched via a bedside mirror as my youngest daughter was born.

It was completely transcendent and an image I will keep with me always. Would I want to share it with the general public? Not a chance.

Bonnie Rochman is a reporter at TIME. Find her on Twitter at @brochman. You can also continue the discussion on TIME's Facebook page and on Twitter at @TIME.

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Pregnancy: Eating Well Cuts the Risk of Birth Defects

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Need more of a reason to eat a healthy diet? Pregnant women who load up on fruits, veggies and whole grains have a reduced risk of having babies with neural tube defects, such as spina bifida or cleft lip, according to one of the first studies to look at the connection between diet and birth defects.

What that means for expectant mothers is that it's not enough just to take folic acid, which doctors recommend as a way to prevent up to 40% of neural tube defects (NTDs). As word has spread among pregnant women about the importance of a folic-acid supplementation, the number of babies born with NTDs has declined — but it hasn't dropped to zero. "We need to keep searching for answers," says Suzan Carmichael, lead author of the study published this week in the Archives of Pediatrics & Adolescent Medicine. 

Carmichael, an associate professor in the pediatrics department at Stanford University, decided to look at the importance of overall nutrition rather than focusing on a single nutrient such as folic acid.

MORE: Operating on Babies in the Womb: For Spina Bifida, It's the Better Option

Researchers studied 6,147 moms of babies without birth defects and 3,411 moms of babies born with NTDs and oral-facial clefts, all of whom were due between 1997 and 2005. They analyzed how closely each woman's diet hewed to two measures of diet quality: the Mediterranean diet and the U.S. Department of Agriculture food pyramid. Both diets emphasize healthy eating from various food groups, but the food pyramid stresses the importance of also including specific nutrients.

"One thing we know is nutrition is much more complex than a single nutrient," says Carmichael.

She found that women who ate the best-quality diets were up to 50% less likely to have a baby with anencephaly, a serious birth defect in which the brain doesn't fully form, than women who ate low-quality diets. They were up to 20% less likely to have a baby with spina bifida and up to 30% less likely to give birth to an infant with cleft lip or cleft palate. The highest-quality diets involved lots of fruits, vegetables and grains and fewer saturated fats and sweets.

MORE: Do We Need Vitamin-Supplemented Birth Control Pills?

The findings held true regardless of whether a woman took prenatal vitamins containing folic acid. "It's not to say that's not important, but we found the quality of diet matters," says Carmichael.

Bottom line: folic acid is important, but so is healthy eating.

Bonnie Rochman is a reporter at TIME. Find her on Twitter at @brochman. You can also continue the discussion on TIME's Facebook page and on Twitter at @TIME.

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Could Taking Birth Control Pills Make Women's Memory More Like Men's?

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A new study shows that taking birth control pills can affect women's memory.

Shawn Nielsen, a graduate student in neurobiology and behavior at the University of California, Irvine, conducted a study with 66 female students, half of whom were taking oral contraception and half who were not.

The participants were given a unique memory test. Some women were randomly assigned to view an emotionally charged video about a young boy who was hit by a car while walking with his mother and then rushed to the hospital, where doctors reattach his severed feet. Other women watched a more neutral narrative in which the mother and son observe a minor accident and then go to the hospital to practice a disaster drill.

Nielsen, who is working toward her doctorate in the lab of Larry Cahill, a well-known hormone researcher, was interested in teasing apart how differences in estrogen and progesterone levels may affect memory. Previous research has hinted that estrogen may enhance verbal memory; in one study, for example, women taking oral contraception showed better recall of words on the active hormone days of their pill cycle than on days when they either weren't supposed to take active pills or took non-hormonal substitutes.

In the current study, when women who viewed the emotional video were tested a week later about what they saw, those who were taking the pill were able to recall the general thread of the story better than its specific details. This is similar to how men remember emotional events, says Nielsen.

"If we reduce women's sex hormone levels, the change in the type of information they recall is more like what a male participant might remember," she says. The pill works by flattening out natural spikes in estrogen and progesterone — which is what triggers ovulation — and signals the body not to make additional hormones, keeping levels low throughout the cycle.

The results were the exact opposite for the women who weren't on the pill: they were better at remembering details, such as what color shirt the boy had on, whether the mother wore glasses, or whether there was a fire hydrant at the intersection. The naturally cycling women couldn't recall the general narrative of the story as well as they could these details.

This doesn't mean that the pill squelches memory or that it robs women of their ability to recall salient things. It's just a matter of what type of information they remember. Since the pill keeps hormone levels steady throughout the cycle, women who take it tend to react differently to emotionally charged experiences, compared with women undergoing the natural monthly ebb and flow of hormones. And that's important since many of the mental illnesses that affect women — such as depression, anxiety and post-traumatic stress disorder — are extremely emotional in nature.

"What is important about these findings is that sex hormones affect the type of information recalled from an emotional event," says Nielsen. "What that says to us is that these changes are a powerful tool for future studies investigating the underlying neurobiology of these disorders.

"Simply taking the pill and suppressing natural sex hormone levels can affect what type of information you remember from an emotional event. That speaks to the role that estrogen and progesterone play in memory — they affect how a woman remembers an emotional event in her life," says Nielsen.

A better understanding of this connection could lead to more effective therapies that may target such hormonal drivers. Nielsen is already trying to figure out exactly what levels of hormones are associated with changes in recall. She is about to launch additional studies to correlate fluctuating levels of estrogen and progesterone in naturally cycling women with changes in the type of information they recall from emotional events.

The current study was published in the journal Neurobiology of Learning and Memory.

Alice Park is a writer at TIME. Find her on Twitter at @aliceparkny. You can also continue the discussion on TIME's Facebook page and on Twitter at @TIME.

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Qualitest recalls birth control pills: FDA

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WASHINGTON | Fri Sep 16, 2011 6:10pm EDT

WASHINGTON (Reuters) - Qualitest Pharmaceuticals is voluntarily recalling several lots of birth control pills because of a packaging error that could leave women at risk for unplanned pregnancy, the U.S. Food and Drug Administration (FDA) said.

Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible, the FDA said in a statement on its website.

The error means the daily regimen for the oral contraceptives may be incorrect and could leave women at risk of an unplanned pregnancy, it said. The defects do not pose any immediate health risks.

"This packaging error and the potential for this error to have affected other oral contraceptive products resulted in the company issuing the recall of multiple lots," the agency said.

The recall takes effect immediately. It includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem and Tri-Previfem.

The affected lot numbers can be found here

Qualitest is a unit of Endo Pharmaceuticals Holdings Inc.

(This story corrects the link to affected lot numbers)

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Qualitest recalls birth control pills: FDA

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WASHINGTON | Fri Sep 16, 2011 6:10pm EDT

WASHINGTON (Reuters) - Qualitest Pharmaceuticals is voluntarily recalling several lots of birth control pills because of a packaging error that could leave women at risk for unplanned pregnancy, the U.S. Food and Drug Administration (FDA) said.

Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible, the FDA said in a statement on its website.

The error means the daily regimen for the oral contraceptives may be incorrect and could leave women at risk of an unplanned pregnancy, it said. The defects do not pose any immediate health risks.

"This packaging error and the potential for this error to have affected other oral contraceptive products resulted in the company issuing the recall of multiple lots," the agency said.

The recall takes effect immediately. It includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem and Tri-Previfem.

The affected lot numbers can be found here

Qualitest is a unit of Endo Pharmaceuticals Holdings Inc.

(This story corrects the link to affected lot numbers)

View the original article here

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HEALTH MANAGEMENT. Researchers examine more recent and secure birth control method

Oregon Health & Science University researchers have discovered a new contraceptive, which is better, more secure and thus a larger population of women available. The research found the OHSU Oregon National Primate Research Center. It is published online in the journal Endocrinology.
Today's birth control methods are several decades old. The food and drug approved administration, for example, "the pill", 1961. It prevents contraception due to increase in the hormone levels of synthetic hormones. This higher hormone levels interrupt the normal menstrual cycle. In short, the synthetic hormones inhibit the release of hormones, responsible for triggering ovulation.
"While the method works, it its disadvantages", said ONPRC scientist Jon Hennebold, PhD. "The main concern is that through a stronger hormone levels, this contraceptive method affects systems in the body of a woman." "Therefore, there are some risks associated with current contraceptive methods, especially heart-cardiovascular disease."
An additional drawback is that hormonal treatments such as the pill of the user of schedule must comply with drugs. Due to this requirement the pill is only about 80 to 90 percent effective.
In contrast, the contraceptive are OHSU researchers develop, is not hormonal and more focused on mechanisms that directly lead the release an egg. This new approach is aimed at the major enzymes responsible for the release of an egg. Hennebold and his colleagues were able to determine exactly what enzymes to focus through the study of rhesus monkeys, which have a very similar reproductive system to humans.
This research in monkeys showed that on these enzymes the release of an egg from the ovary can prevent. The next step for Hennebold and colleagues is the delivery method to determine such drugs and the schedule for drugs.
"Our hope is that the next generation of birth control is targeted and more effective has" Hennebold added. "Much more work is necessary our proposed solution, further, but we believe that better, safe contraceptives are possible."

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