The FDA has just announced that is does not advise doctors to administer magnesium sulfate injections to pregnant women for more than 5 days as a means of preventing pre-term labor.
The use of the drug to prevent pre-term labor is not approved by the FDA, however, doctors often use it “off-label”.
The FDA reported that there are numerous risks associated with the administration of magnesium sulfate injection to pregnant women for longer than 5 days.
It can lead to the following health problems in the developing baby or fetus:
The agency says it does not know what a safe period of treatment with magnesium sulfate injections is, regarding minimizing health problems for the fetus.
This isn’t the first time that experts have warned doctors about the potential health risks associated with administrating magnesium sulfate injections to pregnant women for a prolonged period.
According to a report in Obstetrics and Gynecology,Obstetrics and Gynecology, magnesium sulfate administered intravenously to a pregnant woman who is about to deliver a premature infant is an unconfirmed, ineffective and potentially fatal treatment.
Magnesium sulfate, commonly known as Epsom salts, is an inorganic salt containing sulfur and oxygen. It is medically used to:
- Treat aches and pains
- Prevent cerebral palsy in preterm babies – A study presented at the Society for Maternal-Fetal Medicine’s (SMFM) annual meeting showed that the use of magnesium sulfate (Mg) significantly reduced neonatal brain injury associated with maternal inflammation or maternal infection.
- Manage severe asthma attacks
- Prevent seizures in preeclampsia
- Control of seizures in eclampsia.
Magnesium sulfate is sometimes given to pregnant women who are between 26 and 34 weeks pregnant, for a prolonged period, to delay contractions and allow the injection of steroids, which increases the rate of fetal lung development, subsequently delaying preterm birth.
However, in light of the new FDA Drug Safety Communication, doctors should stop administration of magnesium sulfate for prolonged periods to pregnant women.
Following the new safety information of the medication, the agency will be making several changes to the drug label information for Magnesium Sulfate Injection, USP 50%.
The new labeling changes will include a Warning stating that low calcium levels and bone changes in babies can occur as a result of magnesium sulfate injection beyond 5-7 days during the mother’s pregnancy.
The FDA will also be changing the Pregnancy Category from A to D in a revised Teratogenic Effects section – which shows the extent a drug or other substance is capable of interfering with the development of a fetus.
According to the FDA: “Pregnancy Category D means there is positive evidence of human fetal risk, but the potential benefits from using the drug on pregnant women may be acceptable in certain situations despite its risks.”
Whereas “Pregnancy Category A means that adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters.”
Lastly they will add a Labor and Delivery section stressing that the use of magnesium sulfate injection to treat pre-term labor is not approved by the FDA and may not be safe.
Written by Joseph Nordqvist