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

Related articles

• Fresenius Kabi AG Voluntarily Recalls One Lot of Magnesium Sulfate Injection
• Color Me Pregnant - Is hair dye safe while expecting?
• Opportunity To Study Pregnant Women In Large National Study Must Not Be Missed, Experts Say
• Fresenius Kabi USA Initiates Voluntary Recall of Single Lot of Magnesium Sulfate
• Fresenius Kabi USA Initiates Voluntary Recall of Single Lot of Magnesium Sulfate
• Preeclampsia: It's Scarier than it Sounds
• Magnesium Sulfate Production Equipment
• Taking Epsom Salt Bath
• Union County Walkers Make Strides To Raise Awareness Of Preeclampsia
• Bathe The Inches Away

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.

Related articles

• Simple interventions could save most premature babies
• 15 million babies born prematurely worldwide every year - New WHO report
• Over 1 In Every 10 Babies Born Premature Globally - Medical News Today
• WHO | Born Too Soon: The Global Action Report on Preterm Birth
• 15 million premature babies born each year
• U.S. Ranks 131st in Preterm Births
• U.S. Ranks 131st in World for Premature Birth Rate
• After first baby, weight won't lower preterm risk
• New global report says US lags behind 130 other nations in preterm birth rate