The Food and Drug Administration (FDA) is now warning that magnesium sulfate injections may put a pregnant women’s fetus at risk if injections are administered for more than five days.
Magnesium sulfate is used to prevent preterm labor as an “off-label” medication, which means that the use is not approved by the FDA.
The Food and Drug Administration warns of the following health problems that may develop in an unborn fetus:
- Low calcium levels
- Bone problems
- Osteopenia
- Fractures
Those complications could carry over into early childhood development after birth.
At this time, the FDA has not declared a length of time for which it finds magnesium sulfate injections to be safe for pregnant women experiencing possible preterm labor.
It should be noted that a report in Obstetrics and Gynecology also declared magnesium sulfate injections to be possibly unsafe for an unborn child.
Other Uses for Magnesium Sulfate Injections
Magnesium sulfate is not just used for preventing preterm labor. The medications has also been used for aches and pains, preventing cerebral palsy in preterm babies, managing severe asthma attacks, preventing seizures in pre-eclampsia, and controlling seizures in eclampsia.
Doctors will often inject magnesium sulfate for women who are between 26 and 34 weeks pregnant. Oftentimes, the substance is given for a prolonged period of time to stop contractions while steroids are injected in order to help fetal lung development before birth.
Drug Label Change for Magnesium Sulfate
The FDA’s new warning will soon be placed on the warning labels for Magnesium Sulfate Injection, USP 50%.
The warning will stating that low calcium levels and bone changes in babies can occur if magnesium sulfate injection extends beyond five to seven days
Magnesium sulfate will also be moved from Pregnancy Category A to Pregnancy Category D in a revised Teratogenic Effects section. The new classification suggests that the drug can interfere with fetal development.
The Food and Drug Administration now notes:
“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.”
The FDA is also requiring manufacturers of magnesium sulfate injections to add a labor and delivery section that specifically stipulates that the drugs use for stopping preterm labor is not approved by the FDA.
Image Credit
Magnesium Sulfate Injections and Fetus Complications: https://commons.wikimedia.org/wiki/File:US_Navy_031106-N-8937A-022_Hospital_Corpsman_3rd_Class_Anna_Pesqueira_prepares_an_annual_influenza_vaccination_for_injection.jpg
