Eyes Home > Lotemax and Pregnancy

In animal studies, giving large doses of Lotemax (loteprednol) to pregnant rats and rabbits caused several problems, including miscarriages, abnormal arteries, and low fetal weight. However, these studies involved giving the medication by mouth; using Lotemax properly as an eye medication is probably less likely to cause problems. Before using this eye medication, pregnant women should talk to their healthcare provider.

Can Pregnant Women Use Lotemax?

Lotemax® (loteprednol etabonate) is a prescription medication used to treat eye inflammation. It is a corticosteroid ("steroid") eye medication.
 
At this time, it is unclear if this medication is safe for use during pregnancy. Animal studies indicate that the medication could be harmful to a developing fetus, although the benefits to the mother may outweigh the risks to the fetus in some situations.
 

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans, but do appear to cause harm to the fetus in animal studies.
 
Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
This medication was given a pregnancy Category C rating because of problems seen in animal studies. Giving Lotemax (by mouth) to pregnant rabbits or rats caused the following problems:
 
  • Miscarriages
  • Low fetal weight
  • Meningocele (a type of spina bifida)
  • Abnormal or missing arteries
  • Cleft palate
  • Umbilical hernia
  • Delayed hardening of bones.
     
It should be noted that these studies gave large doses of the medication by mouth. Taking an appropriate Lotemax dosage (as an eye medication) would probably be far less likely to cause problems.
 
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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