The FDA has changed the Pregnancy Category of magnesium sulfate(Drug information on magnesium sulfate)
from ‘A’ to ‘D,’ indicating that there is “positive evidence of human
fetal risk” when the drug is used during pregnancy. The agency cautions
that the drug should not be used for more than 5 to 7 days to stop
preterm labor, and using it for longer periods of time could cause
hypocalcemia, ostopenia, and fractures in the newborn.
The change comes on the heels of a review of epidemiologic data, along with 18 cases of skeletal abnormalities in newborns exposed to magnesium sulfate. While data shows that lab results in newborns return to normal shortly after birth, the long-term effects on bone health are unknown.
The average length of exposure in newborns with skeletal abnormalities was 10 weeks. Journal Watch’s Allison Bryant wrote that, “There are no data suggesting value to using magnesium sulfate for tocolysis for longer than 48 hours, for neuroprotection beyond when delivery is felt to be imminent, or for seizure prophylaxis in the setting of preeclampsia beyond 24 hours postpartum. Therefore, this FDA warning is unlikely to greatly alter current clinical practice."
The change comes on the heels of a review of epidemiologic data, along with 18 cases of skeletal abnormalities in newborns exposed to magnesium sulfate. While data shows that lab results in newborns return to normal shortly after birth, the long-term effects on bone health are unknown.
The average length of exposure in newborns with skeletal abnormalities was 10 weeks. Journal Watch’s Allison Bryant wrote that, “There are no data suggesting value to using magnesium sulfate for tocolysis for longer than 48 hours, for neuroprotection beyond when delivery is felt to be imminent, or for seizure prophylaxis in the setting of preeclampsia beyond 24 hours postpartum. Therefore, this FDA warning is unlikely to greatly alter current clinical practice."
