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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/SafetyAlertsforHuma...
FDA建議醫療專業人員，硫酸鎂 (magnesium sulfate) 注射劑用來阻止孕婦早產勿使用超過5至7天。超過此天數可能會導致嬰兒低血鈣與骨骼問題，包含骨質疏鬆及骨折。可能導致嬰兒傷害的最短治療期間目前仍未知。
硫酸鎂注射劑核准之適應症為預防子癇前症、孕婦患有高血壓和蛋白尿以及控制子癇發作，尚未核准使用於阻止早產。子癇前症和子癇症皆為在懷孕期間可能會發生 且危及生命之併發症，子癇前症可能導致子癇症、癲癇發作、中風、多重器官衰竭，甚至孕婦及胎兒死亡。
有鑑於此新發布之安全警訊，以下資訊將被列入硫酸鎂注射劑，USP 50%之藥品仿單中：
1. 新發布之警訊指出懷孕期間連續給予硫酸鎂注射劑超過5至7天來阻止早產，可能會造成胎兒低血鈣和骨質改變。
2. 於新的致畸性作用 (Teratogenic Effects) 章節中，藉由將懷孕分級由A改成D，表示此藥對發育中胎兒之潛在性傷害。懷孕分級D表示已證實對胎兒有害，但於某些特殊情況下，權衡利弊，孕婦仍可使用。
3. 於新的分娩與生產 (Labor and Delivery) 章節中，強調目前未核准連續給予硫酸鎂注射劑來阻止早產，且使用於此適應症之安全性與療效尚未建立。當懷孕婦女使用此藥於非核可之適應症時，應於產科設備 齊全之醫院，由專業醫療人員給予。
懷孕婦女應與醫療專業人員討論發生早產的可能性以及使用任何治療之風險與利益。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm354603.htm
[Posted 05/31/2013]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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資料來源：藥師週刊（第1826期）
