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The American College of Obstetricians and Gynecologistsand the Society for Maternal-Fetal Medicine have longsupported the short-term use of magnesium sulfate inobstetric care for appropriate conditions and for appro-priate durations of treatment. The U.S. Food and DrugAdministration (FDA) advises against use of magnesiumsulfate injection for more than 5–7 days to stop pretermlabor in pregnant women. Based on this, the drug clas-sification was changed from Category A to Category D,

and the labeling was changed to include this new warninginformation (1). The change was prompted by concernfor fetal and neonatal bone demineralization and frac-tures associated with long-term in utero exposure tomagnesium sulfate. These concerns are based both onunsolicited reports to the FDA’s Adverse Event ReportingSystem and results from a number of epidemiologicanalyses, although these studies have important limita-tions in design (2–7). There are 18 cases in the AdverseEvent Reporting System database that report fetal andneonatal long bone demineralization and fractures. It isimportant to note that in these cases, the average duration

of prenatal magnesium sulfate exposure was 9.6 weeks,with an average total maternal dose of 3,700 g, a muchlonger duration and much higher dose than is currentlyrecommended for obstetric use. In addition, sample sizesin available population studies were generally small, mak-ing the conclusions of these studies subject to confound-ing and bias (2–7).

Magnesium sulfate has been used in obstetrics fordecades, and thousands of women have been enrolled in

clinical trials that studied the efficacy of prenatal magne-sium sulfate for a variety of conditions (8–11). Concernsabout fetal and neonatal bone demineralization and frac-ture have not been raised from these studies, includingrecent trials of magnesium for neuroprotection. The usesof magnesium sulfate in the context of appropriate clini-cal obstetric practice include, in particular, preventionand treatment of seizures in women with preeclampsiaor eclampsia and fetal neuroprotection before anticipatedearly preterm (less than 32 weeks of gestation) delivery(8, 9, 12). Magnesium sulfate also may be used for theshort-term prolongation of pregnancy (up to 48 hours)

Magnesium Sulfate Use in ObstetricsABSTRACT:  The U.S. Food and Drug Administration advises against the use of magnesium sulfate injec-

tions for more than 5–7 days to stop preterm labor in pregnant women. Based on this, the drug classification was

changed from Category A to Category D, and the labeling was changed to include this new warning information.

However, the U.S. Food and Drug Administration’s change in classification addresses an unindicated and non-

standard use of magnesium sulfate in obstetric care. The American College of Obstetricians and Gynecologists

and the Society for Maternal-Fetal Medicine continue to support the short-term (usually less than 48 hours) use of

magnesium sulfate in obstetric care for appropriate conditions and for appropriate durations of treatment, which

includes the prevention and treatment of seizures in women with preeclampsia or eclampsia, fetal neuroprotec-

tion before anticipated early preterm (less than 32 weeks of gestation) delivery, and short-term prolongation of

pregnancy (up to 48 hours) to allow for the administration of antenatal corticosteroids in pregnant women who are

at risk of preterm delivery within 7 days.

The American College of Obstetricians and Gynecologists Committee on Obstetric Practice

Society for Maternal–Fetal MedicineThis document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should

not be construed as dictating an exclusive course of treatment or procedure to be followed.

COMMITTEE OPINIONNumber 652 • January 2016 (Replaces Committee Opinion Number 573, September 2013) 

The American College ofObstetricians and GynecologistsWOMEN’S HEALTH CARE PHYSICIANS

INTERIM UPDATE: This Committee Opinion is updated to reflect a limited, focused change in gestational age at whichto consider tocolysis.

INTERIM UPDATE

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2 Committee Opinion No. 652

to allow for the administration of antenatal corticoste-roids. Tocolysis is not recommended beyond 34 weeksof gestation, and it is generally not recommended before24 weeks of gestation but may be considered based onindividual circumstances at 23 weeks (13). Practitionersshould not stop using magnesium sulfate for these indi-cations based on the FDA reclassification. In all of these

conditions, prolonged use of magnesium sulfate is neverindicated. Therefore, the FDA’s change in the pregnancyclassification of magnesium sulfate addresses an unindi-cated and nonstandard use of this medication.

Conclusions

The American College of Obstetricians and Gynecologistsand the Society for Maternal-Fetal Medicine continue tosupport the short-term (usually less than 48 hours) useof magnesium sulfate in obstetric care for appropriateconditions and for appropriate durations of treatment,which include the following:

  • Prevention and treatment of seizures in women withpreeclampsia or eclampsia.

• Fetal neuroprotection before anticipated early pre-term (less than 32 weeks of gestation) delivery.

  • Short-term prolongation of pregnancy (up to 48hours) to allow for the administration of antenatalcorticosteroids in pregnant women who are at risk ofpreterm delivery within 7 days.

References

  1. Food and Drug Administration. FDA recommends againstprolonged use of magnesium sulfate to stop pre-term labor

due to bone changes in exposed babies. FDA Drug SafetyCommunication. Silver Spring (MD): FDA; 2013. Availableat: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM353335.pdf . Retrieved June 12, 2013.^

  2. Yokoyama K, Takahashi N, Yada Y, Koike Y, Kawamata R,Uehara R, et al. Prolonged maternal magnesium adminis-tration and bone metabolism in neonates. Early Hum Dev2010;86:187–91. [PubMed] [Full Text] ^

  3. McGuinness GA, Weinstein MM, Cruikshank DP, PitkinRM. Effects of magnesium sulfate treatment on perinatalcalcium metabolism. II. Neonatal responses. Obstet Gynecol1980;56:595–600. [PubMed] [Obstetrics & Gynecology ] ^

  4. Holcomb WL Jr, Shackelford GD, Petrie RH. Magnesium

tocolysis and neonatal bone abnormalities: a controlled

study. Obstet Gynecol 1991;78:611–4. [PubMed] [Obstetrics  & Gynecology ]^

  5. Schanler RJ, Smith LG Jr, Burns PA. Effects of long-termmaternal intravenous magnesium sulfate therapy on neo-natal calcium metabolism and bone mineral content.Gynecol Obstet Invest 1997;43:236–41. [PubMed]^

  6. Matsuda Y, Maeda Y, Ito M, Sakamoto H, Masaoka N,

Takada M, et al. Effect of magnesium sulfate treatmenton neonatal bone abnormalities. Gynecol Obstet Invest1997;44:82–8. [PubMed] ^

  7. Nassar AH, Sakhel K, Maarouf H, Naassan GR, Usta IM.Adverse maternal and neonatal outcome of prolongedcourse of magnesium sulfate tocolysis. Acta Obstet GynecolScand 2006;85:1099–103. [PubMed] [Full Text] ^

  8. Magnesium sulfate before anticipated preterm birth forneuroprotection. Committee Opinion No. 455. AmericanCollege of Obstetricians and Gynecologists. Obstet Gynecol2010;115:669–71. [PubMed] [Obstetrics & Gynecology ] ^

  9. Diagnosis and management of preeclampsia and eclamp-sia. ACOG Practice Bulletin No. 33. American College of

Obstetricians and Gynecologists. Obstet Gynecol 2002;99:159–67. [PubMed] [Obstetrics & Gynecology ] ^

  10. Mercer BM, Merlino AA, Society for Maternal-FetalMedicine. Magnesium sulfate for preterm labor and pre-term birth. Obstet Gynecol 2009;114:650–68. [PubMed] [Obstetrics & Gynecology ] ^

  11. Chronic hypertension in pregnancy. Practice BulletinNo. 125. American College of Obstetricians and Gynecol-ogists. Obstet Gynecol 2012;119:396–407. [PubMed] [Obstetrics & Gynecology ] ^

  12. Management of preterm labor. Practice Bulletin No. 127.American College of Obstetricians and Gynecologists.Obstet Gynecol 2012;119:1308–17. [PubMed]  [Obstetrics  & Gynecology ]^

  13. Periviable birth. Obstetric Care Consensus No. 3. AmericanCollege of Obstetricians and Gynecologists. Obstet Gynecol2015;126:e82–94. [PubMed] [Obstetrics & Gynecology ]^

Copyright January 2016 by the American College of Obstetriciansand Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC20090-6920. All rights reserved.

ISSN 1074-861X

Magnesium sulfate use in obstetrics. Committee Opinion No. 652.American College of Obstetricians and Gynecologists. Obstet Gynecol2016;127:e52–3.

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