The Food and Drug Administration (FDA) recently issued a warning to health care professionals against using magnesium sulfate injection for more than five to seven days to stop pre-term labor in pregnant women. In its statement, the agency said the use of the drug is “off-label”, meaning that this is not an approved use of the drug. The FDA said that prolonged use of the drug may lead to low calcium levels and bone problems in the developing baby or fetus, including osteopenia (an illness that results in thin bones) and bone fractures. The shortest duration of magnesium sulfate injection that results in harm to babies is unknown at this time.
The FDA found eighteen case reports in its Adverse Events Reporting System describing skeletal abnormalities in infants exposed in utero to magnesium sulfate. The average duration of exposure was ten weeks. The magnesium was given to mothers in attempts to stop early, pre-term contractions and labor. In those cases, the babies developed skeletal abnormalities and multiple fractures involving the ribs and long bones.
Magnesium sulfate shots are used to stop premature labor.
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.
The FDA is now requiring magnesium sulfate manufacturers to add warning labels to the medication letting patients know they are putting their infants at risk if they prolong treatment. The new warning states that a continuous administration of magnesium sulfate beyond five to seven days can cause low calcium levels and bone changes in the unborn baby. The label will also have a new labor and delivery section emphasizing the continuous use of magnesium sulfate injection to treat preterm labor is not approved. The FDA is also requiring a new “Tetrogenic Effects” section that warns about the potential harm to developing babies.
Our medical malpractice law firm has put together a birth injury information guide that offers preliminary advice about what to do if your child suffered any kind of injury during delivery. The information will help you understand about your legal rights and options for seeking compensation.