Magnesium Sulfate: against prolongued use in pre-term labor

Magnesium Sulfate: Drug Safety Communication - Recommendation Against Prolonged Use in Pre-term Labor

AUDIENCE: OB/GYN, Nursing, Risk Manager
ISSUE: FDA is advising health care professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant women. Administration of magnesium sulfate injection to pregnant women longer than 5-7 days may lead to low calcium levels and bone problems in the developing baby or fetus, including thin bones (osteopenia), and fractures. The shortest duration of treatment that can result in harm to the baby is not known. See the Data Summary in the Drug Safety Communication for additional information.
BACKGROUND: This use of the drug is off-label, and is not an FDA-approved use of the drug. Magnesium sulfate is approved to prevent seizures in preeclampsia, a condition in which the pregnant woman develops high blood pressure and protein in the urine, and for control of seizures in eclampsia. Both preeclampsia and eclampsia are life-threatening complications that can occur during pregnancy. Preeclampsia can lead to eclampsia, seizures, stroke, multiple organ failure, and death of the woman and/or baby.
RECOMMENDATIONS: In light of this new safety information about low calcium levels and bone problems in the developing baby, the following information is being added to the drug label for Magnesium Sulfate Injection, USP 50%:

• A new Warning stating that continuous administration of magnesium sulfate injection beyond 5-7 days in pregnancy for the treatment of pre-term labor can cause low calcium levels and bone changes in the baby.
• A new Teratogenic Effects section conveying the potential harm to developing babies by changing the Pregnancy Category to D from A. Pregnancy Category D means there is positive evidence of human fetal risk, but the potential benefits from using the drug in pregnant women may be acceptable in certain situations despite its risks.
• A new Labor and Delivery section emphasizing that continuous administration of magnesium sulfate injection to treat pre-term labor is not approved and that the safety and efficacy of use for this indication are not established. When used in pregnant women for conditions other than its approved indication, magnesium sulfate injection should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Pregnant women should discuss with their health care professional the possibility of going into labor before term and the risks and benefits of any treatments that may be used.
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm354603.htm

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Mississippi considers prosecuting women for stillbirths and miscarriages

Believe it or not, Mississipi is still in flames. .........

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Published time: May 26, 2013 18:15

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The Supreme Court of Mississippi is currently considering a case that could lead to charges of manslaughter for women who suffer miscarriages or stillbirths.
Nina Buckhalter was indicted for manslaughter in 2009 after giving birth to a stillborn baby girl named Hayley 31 weeks into her pregnancy.
According to a Mother Jones report, those charges were based on the detection of methamphetamines in Buckhalter’s system, which led a grand jury in Mississippi to declare that the defendant "did willfully, unlawfully, feloniously, kill Hayley Jade Buckhalter, a human being, by culpable negligence."
Now the court is set to rule on whether the prosecution can move forward after hearing oral arguments on the case on April 2.
According to Farah Diaz-Tello, an attorney with National Advocates for Pregnant Women and part of Buckhalter’s legal defense, if her case goes forward it could well lead to a spate of similar prosecutions in Mississippi and other US states.
The fear now is setting a precedent that "unintentional pregnancy loss can be treated as a form of homicide," says Farah Diaz-Tello.
Mississippi's manslaughter laws were never intended to apply in cases of stillbirths and miscarriages, according to reporting by Mother Jones. However, Mississippi prosecutors believe that two state laws allow them to charge Buckhalter. One law defines manslaughter as the “killing of a human being, by the act, procurement or culpable negligence of another”, while the second includes “an unborn child at every stage of gestation from conception until live birth” as the state’s definition of human beings.
Mississippi is widely considered one of the most socially conservative states in the US, and as recently as 2011 a state ballot measure had sought to grant full rights to fertilized eggs, effectively making abortion illegal.
Lawmakers are also actively looking to shut down the state’s sole women's health clinic that performed abortions.

Reuters / Kim Kyung-Hoon

Diaz-Tello believes that the underlying motivation behind Buckhalter’s case is an attempt to establish “personhood” for fetuses, a central issue in the contentious arguments for banning abortions which rely on a legal definition of an unborn child’s “viability” or rather the state’s definition of life.
The definition of “personhood” could, in turn, allow the introduction of further laws regulating or banning the use of emergency contraceptives such as Plan B, or be used in further arguments in restricting access to abortion services.
Robert McDuff, a Mississippi civil rights lawyer also representing Buckhalter, argued to the state Supreme Court that the state’s law defining homicide as including the killing of a child includes an exemption for women seeking a legal abortion.
McDuff argues that, if women in Mississippi can legally terminate unwanted pregnancies, this should carry over to unintentionally ending a wanted pregnancy.
At least a dozen medical and public health groups have filed a friend-of-the-court brief in the Buckhalter case, including the American Medical Association, the American Academy of Pediatrics and the American College of Obstetricians.
In that brief the group argues that threat of prosecution might actually lead to more abortions by women dealing with drug or alcohol addiction, or could raise the risk of miscarriage or stillbirth by women who fear they may be reported by medical professionals to the state.
Earlier in the year the state of Alabama set a precedent for prosecuting pregnant women for drug use when it upheld convictions against Amanda Kimbrough and Hope Ankrom for “chemical endangerment” of a child. As Mother Jones notes, that 2006 law was aimed to punish individuals who expose children rather than fetuses to illegal drugs, and as in the case of Buckhalter seems to have further defined “personhood.”

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A pregnant woman (Photo credit: Wikipedia)

Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches

Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics

[Posted 05/06/2013]
AUDIENCE: Health Professional, Neurology, Pharmacy, Patient
ISSUE: FDA is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant women clearly outweighs any possible benefit of the drug).
Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder.
BACKGROUND: Valproate products are approved for the treatment of certain types of epilepsy, the treatment of manic episodes associated with bipolar disorder, and the prevention of migraine headaches. They are also used off-label (for uses not approved by FDA) for other conditions, particularly other psychiatric conditions.
This alert is based on the final results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study showing that children exposed to valproate products while their mothers were pregnant had decreased IQs at age 6 compared to children exposed to other anti-epileptic drugs. For additional details, see the Drug Safety Communication Data Summary section.
RECOMMENDATION: Valproate products should not be used in pregnant women for prevention of migraine headaches and should be used in pregnant women with epilepsy or bipolar disorder only if other treatments have failed to provide adequate symptom control or are otherwise unacceptable. 
Women who are pregnant and taking a valproate medication should not stop their medication but should talk to their health care professionals immediately. Stopping valproate treatment suddenly can cause serious and life-threatening medical problems to the woman or her baby.

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Preeclampsia as a Risk Factor for Diabetes: A Population-Based Cohort Study

Belly of a woman in her 34th week of pregnancy. (Photo credit: Wikipedia)

See original in PLoS

Background

Women with preeclampsia (PEC) and gestational hypertension (GH) exhibit insulin resistance during pregnancy, independent of obesity and glucose intolerance. Our aim was to determine whether women with PEC or GH during pregnancy have an increased risk of developing diabetes after pregnancy, and whether the presence of PEC/GH in addition to gestational diabetes (GDM) increases the risk of future (postpartum) diabetes.

Methods and Findings

We performed a population-based, retrospective cohort study for 1,010,068 pregnant women who delivered in Ontario, Canada between April 1994 and March 2008. Women were categorized as having PEC alone (n = 22,933), GH alone (n = 27,605), GDM alone (n = 30,852), GDM+PEC (n = 1,476), GDM+GH (n = 2,100), or none of these conditions (n = 925,102). Our main outcome was a new diagnosis of diabetes postpartum in the following years, up until March 2011, based on new records in the Ontario Diabetes Database. The incidence rate of diabetes per 1,000 person-years was 6.47 for women with PEC and 5.26 for GH compared with 2.81 in women with neither of these conditions. In the multivariable analysis, both PEC alone (hazard ratio [HR] = 2.08; 95% CI 1.97–2.19) and GH alone (HR = 1.95; 95% CI 1.83–2.07) were risk factors for subsequent diabetes. Women with GDM alone were at elevated risk of developing diabetes postpartum (HR = 12.77; 95% CI 12.44–13.10); however, the co–presence of PEC or GH in addition to GDM further elevated this risk (HR = 15.75; 95% CI 14.52–17.07, and HR = 18.49; 95% CI 17.12–19.96, respectively). Data on obesity were not available.

Conclusions

Women with PEC/GH have a 2-fold increased risk of developing diabetes when followed up to 16.5 years after pregnancy, even in the absence of GDM. The presence of PEC/GH in the setting of GDM also raised the risk of diabetes significantly beyond that seen with GDM alone. A history of PEC/GH during pregnancy should alert clinicians to the need for preventative counseling and more vigilant screening for diabetes.

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Prophylactic oral betamimetics for preventing preterm labour in singleton pregnancies.

Causes of death by age group (see List of causes of death by rate) (Photo credit: Wikipedia)

Background

Preterm birth occurs in up to 6% to 10% of all births and is the major complication of pregnancy associated with perinatal mortality and morbidity. Previous preterm delivery is a strong predictor for preterm labour, and the earlier the birth, the more likely it is to be repeated at the same gestation. In the acute setting, betamimetics can decrease contraction frequency or delay preterm birth by 24 to 48 hours.

Objectives

To assess the effectiveness of prophylactic oral betamimetics for the prevention of preterm labour and birth for women with singleton pregnancies at high risk of preterm delivery.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (October 2010) and reference lists.

Selection criteria

Randomised controlled trials in singleton pregnancies at high risk of preterm labour comparing prophylactic oral betamimetics with placebo or any intervention with the specific aim of preventing preterm birth.

Data collection and analysis

Two authors independently assessed trial quality and extracted data.

Main results

One trial (64 singleton pregnancies) was included. The trial compared the oral betamimetic agent isoxuprine with placebo. No difference was seen for perinatal mortality rate (risk ratio (RR) 4.74, 95% confidence interval (CI) 0.50 to 45.00). There was no evidence of an effect of oral betamimetic agents in reduction of spontaneous onset of preterm labour (RR 1.07, 95% CI 0.14 to 8.09) or preterm birth, less than 37 weeks' gestation. There was no significant association between the use of oral betamimetics and side effects sufficient to stop therapy (RR 2.51, 95% CI 0.59 to 10.76). No differences were found for infant outcomes; birthweight less than 2500 grams (RR 1.74, 95% CI 0.44 to 6.87) or neonatal death (RR 4.74, 95% CI 0.50 to 45.00). This trial had adequate methodological quality; however the sample size was inappropriate to determine any significance in neonatal outcome differences between the treatment groups.

Authors' conclusions

There is insufficient evidence to support or refute the use of prophylactic oral betamimetics for preventing preterm birth in women at high risk of preterm labour with a singleton pregnancy.

 

Prophylactic oral betamimetics for preventing preterm labour in singleton pregnancies

There are insufficient data on use of betamimetic drugs given by mouth to reduce preterm birth in women at increased risk of preterm labour and carrying one baby.
Women sometimes go into labour early and babies are born prematurely (before 37 weeks). These babies are at increased risk of health problems and the earlier a baby is born the higher the risk. Babies born before 32 weeks have considerable problems, with those born before 28 weeks being at most risk. These babies can suffer from problems with breathing, bleeding, gut and intestines. They are also at increased risk of cerebral palsy or long-term handicap, and some babies do not survive even the early weeks. Babies need special care, sometimes intensive care, and this can be quite traumatic for parents. Preterm birth occurs in around 6% to 10% of births. Many interventions have been assessed to try to improve outcomes for these babies; this review looks at a group of drugs called betamimetics given by mouth in women at increased risk and carrying one baby. These drugs aim to reduce and inhibit labour contractions. However, they do have side effects which include nausea, vomiting, tremor, headaches and shortness of breath. The review of studies found only one trial involving 64 women. There is therefore insufficient evidence to support the use of these drugs to reduce preterm labour and birth.

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