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June 19, 2013
On May 30, 2013, the Food and Drug Administration (FDA) advised health care professionals that they should not use magnesium sulfate injection for more than five to seven days in attempting to stop preterm labor in pregnant women.
Risks of using the drug for more than five to seven days include low calcium levels in the patient as well as bone problems in the developing baby, including thin bones (osteopenia) and bone breaks (fractures). The FDA stated that it is not...
June 19, 2013
On May 30, 2013, the Food and Drug Administration (FDA) advised health care professionals that they should not use magnesium sulfate injection for more than five to seven days in attempting to stop preterm labor in pregnant women.
Risks of using the drug for more than five to seven days include low calcium levels in the patient as well as bone problems in the developing baby, including thin bones (osteopenia) and bone breaks (fractures). The FDA stated that it is not known whether these increased risks of harm can be eliminated by using the drug for fewer than five days.
Use of magnesium sulfate to stop preterm labor is off-label, meaning that the FDA has neither approved the drug for this use nor assessed its safety and efficacy for this indication. (Magnesium sulfate is FDA-approved to treat preeclampsia and eclampsia, which are serious, life-threatening conditions of pregnancy.)
Women at higher risk for preterm labor should be aware of this FDA announcement. Risk factors for preterm labor include:
- previous preterm labor, premature birth or miscarriage
- pregnancy with twins, triplets or other multiples
- use of cigarettes, alcohol or illegal drugs
- pregnancy complications, such as preeclampsia
- underweight or overweight before pregnancy
- chronic conditions such as high blood pressure or diabetes
