plus 4, FDA Warns Pregnant Women Taking Depakote, Depakene - Psych Centra

FDA Warns Pregnant Women Taking Depakote, Depakene - Psych Centra
New report urges more investment to slash maternal and newborn deaths ... - Balita News
Glucose intolerance in pregnancy linked to postpartum risk - Zee News
Nigeria: 144 women die daily from pregnancy complications - NEXT
Health Tip: Women who have GBS during pregnancy - WBOC

FDA Warns Pregnant Women Taking Depakote, Depakene - Psych Centra

Posted: 05 Dec 2009 09:47 AM PST

The U.S. Food and Drug Administration (FDA) last week notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy.

Depakote and depakene are common brand names for valproic acid, which is commonly used to treat bipolar disorder in men and women.

Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.

Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant.

Using valproate during pregnancy increases the chance of having a baby with a birth defect. Neural tube defects, such as spina bifida, are the birth defects most often seen with valproate use in early pregnancy.These defects of the brain and spinal cord occur when the developing spinal canal does not close normally.

For this reason, a woman of childbearing potential should generally not take valproate unless it is considered essential for her treatment. Women of childbearing potential are women who have passed puberty and have not passed through menopause and have not had their uterus or ovaries removed.

Women of childbearing potential who do take valproate should use effective birth control (contraception) while taking valproate.

Women who are planning a pregnancy or who become pregnant while taking valproate should contact their healthcare professionals immediately.They should talk to their healthcare professionals about the best way to treat their health conditions before and during pregnancy. Healthcare professionals may discuss other treatment options.

Valproate should not be stopped without talking to a healthcare professional, even in pregnant women. Stopping valproate suddenly can cause serious problems. Not treating epilepsy or bipolar disorder can be harmful to women and their developing babies.

Women who become pregnant while taking valproate or other antiepileptic drugs (AEDs) should consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Women can do this by calling the toll-free number 1-888-233-2334. This pregnancy registry gathers information about the safety of antiepileptic drugs during pregnancy.

It is important to know that birth defects also occur in babies born to women who are not taking any medicines and who do not have other risk factors, but they occur less often (in about 3 out of every 100 babies).

Taking folic acid supplements before getting pregnant and during early pregnancy has been shown to lower the chance of having a baby with a neural tube defect.

Women should tell their healthcare professionals about all the medicines they take, including prescription and non-prescription medicines, vitamins, and herbal supplements, and should not start a new medicine without first talking with a healthcare professional.

FDA first approved Depakene (valproic acid) in 1978 for the treatment of epilepsy. More recently, FDA approved valproate for the treatment of bipolar disorder and migraine headaches. As valproate's indications for use expand, it is critical that all health care professionals caring for women of childbearing potential and taking valproate for any indication be informed that valproate causes an increased risk of major birth defects. Awareness of the therapeutic benefits and risks of valproate and alternative therapies, as well as the risks of untreated disease, is critical for informed prescribing and counseling of all women taking valproate.

Valproate use during pregnancy increases the risk of major malformations, including neural tube defects. In the United States, about 1 in 1500 babies is born with a neural tube defect. The risk of neural tube defects is much higher in babies born to mothers treated with valproate during the first 12 weeks of pregnancy, with the risk increasing to 1 in 20 babies.

Data from the NAAED Pregnancy Registry show that the rate of major malformations in babies born to women with epilepsy taking valproate (monotherapy) is almost 4 times higher than the rate of major malformations in babies born to women with epilepsy taking a different antiepileptic drug. The NAAED Registry reported a major malformation rate of 10.7% (95% C.I. 6.3% – 16.9%) in the offspring of women exposed to an average of 1,000 mg/day of valproic acid monotherapy during pregnancy (dose range 500 – 2000 mg/day). The major malformation rate among the internal comparison group of 1,048 women with epilepsy who received any other antiepileptic drug monotherapy during pregnancy was 2.9% (95% CI 2.0% to 4.1%). Sixteen major malformations occurred in the offspring of 149 women who used valproate during pregnancy, and these malformations included neural tube defects, craniofacial defects, cardiovascular malformations and malformations involving other body systems.

Studies in the general population show that folic acid supplementation prior to conception and during early pregnancy reduces the risk of neural tube defects. To ensure adequate folic acid intake, women of childbearing potential should use FDA approved folic acid prescription drugs and not rely on dietary intake or supplements alone.

Source: U.S. Food and Drug Administration

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New report urges more investment to slash maternal and newborn deaths ... - Balita News

Posted: 04 Dec 2009 06:28 AM PST

December 4, 2009 11:02 pm

UNITED NATIONS, Dec. 4 — The more than four million annual maternal and newborn deaths in developing countries could be dramatically reduced if the world doubled investment in family planning and pregnancy-related care to $ 24.6 billion, according to a new UN report.

The report, by the United Nations Population Fund (UNFPA) and the Guttmacher Institute, stated that scaling up investment could reduce maternal deaths by 70 percent and newborn deaths by half. It also found that investments in family planning boost the overall effectiveness of every dollar spent on the provision of pregnancy-related and newborn health care.

"It is a win-win situation. We know what must be done, we know what it will cost, and we now know that the needed investment is modest in relation to the vast benefits that will follow," said UNFPA Executive Director Thoraya Ahmed Obaid. "It is critical to the progress of the world's most disadvantaged countries and regions to address the high rates of maternal and newborn deaths that have long been endemic. Investing simultaneously in family planning and in maternal and newborn health is cost-effective," she said. The report showed that meeting the need for both family planning and maternal and newborn health services would prevent the deaths of nearly 400,000 women and 1.6 million infants. "It's not rocket science," Dr. Sharon Camp, president of the Guttmacher Institute, said. "Investing in a handful of basic health services, like family planning and routine delivery care, can save millions of women and babies." Even with the US$ 12 billion spent a year on family planning and maternal health programs in developing nations, 215 million women who want to avoid pregnancy are not using an effective method of contraception, and only about half of the 123 million women who give birth each year receive the antenatal, delivery and newborn care they need. The report also cited additional benefits of investing in family planning and maternal health. Preventing unwanted pregnancies will also increase women's educational and employment opportunities, and enhance their social and economic status, the report added, while noting that family savings and investment would rise, spurring economic growth and reducing poverty. "The report outlines how to best focus resources to achieve the greatest gains. Investing in women has enormous benefits, not just for individuals and families, but for societies as a whole. It can truly transform the future of developing nations," Camp said. (PNA/APP) FFC/rsm

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Glucose intolerance in pregnancy linked to postpartum risk - Zee News

Posted: 01 Dec 2009 09:47 PM PST

Washington: A new study, led by an Indian-origin boffin, has revealed that women who have gestational glucose intolerance (a condition less severe than gestational diabetes) exhibit multiple cardiovascular risk factors as early as three months after birth.

Study's lead author Ravi Retnakaran, of Mount Sinai Hospital and the University of Toronto, and colleagues sought to evaluate the relationship between gestational glucose intolerance and postpartum risk of metabolic syndrome (defined as the clustering of several cardiometabolic risk factors including obesity, hypertension and low HDL cholesterol).

Metabolic syndrome, like gestational diabetes itself, is linked to an increased risk of developing type 2 diabetes and cardiovascular disease.

Retnakaran and colleagues followed 487 women who underwent oral glucose tolerance testing during pregnancy. Each subject was classified as either having normal glucose tolerance, gestational glucose intolerance or gestational diabetes.

At three months postpartum, researchers evaluated each subject's cardiometabolic characteristics, such as blood pressure, weight, waist measurement and lipid levels.

The researchers found that even mild glucose intolerance during pregnancy predicts an increased likelihood of the metabolic syndrome at 3 months postpartum.

The presence of cardiovascular risk factors as early as three months postpartum indicates that these risk factors may be longstanding and contribute to the long-term risk of cardiovascular disease in this patient population.

"The study findings raise the important possibility that women with gestational glucose intolerance and subsequent postpartum metabolic syndrome represent a patient population at particularly high risk for the future development of metabolic and vascular disease. Further research with long-term follow-up is needed to address this possibility," said Retnakaran.

The study is to be published in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM).

ANI

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Nigeria: 144 women die daily from pregnancy complications - NEXT

Posted: 05 Dec 2009 03:02 PM PST

The number of women dying from pregnancy-related complications in Nigeria is similar to a plane crashing every day, but the crisis gets less noticed amid pandemics such as AIDS and malaria, activists say.

At least 144 women die each day in Nigeria during pregnancy or childbirth, according to the UN and World Bank statistics, placing it among some of the worst countries for women to deliver babies in the world, after Sierra Leone and Niger among others.

"Imagine a plane crash in Nigeria everyday, carrying only pregnant women. Would we stand by and do nothing? But this is precisely the case -- death through pregnancy and child birth has almost become invisible," Sandra Obiago, director of a local lobby group, Communicating for Change, said.

Activists, on Thursday, premiered three short but hard-hitting Nollywood films to advocate for an urgent change in attitude and provision of adequate health care services to avoid pregnancy-related problems.

The films take a provocative look at the deadly crisis in sub-Saharan Africa's second largest economy and the world's eight largest oil exporter, where some 70 per cent of the 150 million people live on less than a dollar a day.

Nigeria lacks some of the basic infrastructure such as electricity and good roads, while skilled medical personnel is just not enough for Africa's most populous country.

"It's a failure of governance, we must make our leaders accountable to make sure they provide the infrastructure," said a civil and human rights activist, Yemisi Ransome-Kuti.

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Health Tip: Women who have GBS during pregnancy - WBOC

Posted: 05 Dec 2009 10:51 AM PST

(HealthDay News) -- Group B streptococcus (GBS) is a bacterium that is found in as many as 30 percent of pregnant women, the American Congress of Obstetricians and Gynecologists says.

GBS is not sexually transmitted, and although it has a similar name, it is not the bacterium that causes strep throat.

Most babies exposed to the germ don't get sick, but a few develop serious complications. That's why many women are treated with antibiotics during delivery as a precaution.

The ACOG says these women are candidates for precautionary treatment:

Women who have had a previous baby infected with GBS.
Women who had a urinary tract infection with GBS earlier in the pregnancy.
Women who had a positive GBS culture test during the pregnancy.
Women whose GBS status is unknown and who deliver at earlier than 37 weeks of pregnancy.
Women whose GBS status is unknown and who have a fever during labor.

-- Diana Kohnle