Alrex and Pregnancy
In animal studies on pregnancy and Alrex, the medication caused miscarriages and various birth defects when it was given by mouth to pregnant rabbits and rats. However, taking an appropriate dosage and using the medication as an eye drop would be less likely to cause problems. If you are using this medication and pregnancy occurs, talk to your healthcare provider about the potential risks.
Alrex® (loteprednol etabonate) is a prescription medication used to treat eye allergies. It is a corticosteroid ("steroid") eye drop. It is not known if this medication is safe for use during pregnancy. Animal studies indicate that the medication could be harmful to a developing fetus.
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 that 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 Alrex (by mouth) to rabbits or rats caused the following problems:
- Meningocele (a type of spina bifida)
- Abnormal or missing arteries
- Cleft palate
- Umbilical hernia
- Low fetal weight
- Delayed hardening of bones.
It should be noted that these studies gave large doses of the medication by mouth. Taking an appropriate Alrex dosage (as an eye drop) would be 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.