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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (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. This use of the drug is off-label, which means that it is not an FDA-approved use of the drug. 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, called osteopenia, and bone breaks, called fractures. The shortest duration of treatment that can result in harm to the baby is not known.
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.
For more information, please visit: Magnesium Sulfate
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