NEW FDA Recommendation on Pre-Term Labor

The Office on Women’s Health (OWH) sent this bulletin at 06/05/2013 05:44 PM EDT

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FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-Term Labor

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 longer than 5-7 days may lead to low calcium levels and bone problems in the developing fetus. 

The Pregnancy Category for the drug is changing to D from A. Pregnancy Category D means that 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. 

Read the drug safety communication for more information for health professionals and patients.