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Mitosol and Pregnancy

Based on the results of animal studies, Mitosol (mitomycin ophthalmic) is considered a pregnancy Category X medicine. This means that this drug can cause dangerous problems in an unborn child. Giving this drug intravenously to pregnant animals caused various birth defects, such as cleft palate, clubfoot, and defects of the reproductive organs.

Can Pregnant Women Use Mitosol?

Mitosol® (mitomycin ophthalmic) can be quite dangerous for use in women who are or may become pregnant. This is based on animal studies that looked at the effects of using the drug during pregnancy. Mitosol has been given a pregnancy Category X classification based on its dangerous risks to an unborn child.

What Is Pregnancy Category X?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
When the active ingredient of the medicine (mitomycin) was given by injection to pregnant rats and mice during animal studies, it caused a variety of birth defects, such as:
  • Clubfoot
  • Cleft palate
  • Defects of the toes, fingers, and reproductive organs.
These defects occurred in doses that were equivalent to the usual recommended human intravenous (IV) dose.
Mitosol has not been studied in pregnant women. In addition, mitomycin has only been studied as an injection in animals. The topical use of the drug applied to the eye, as would be the case with Mitosol use, has not been studied. Nonetheless, based on the harmful effects observed when the drug was given by injection to pregnant animals, it is recommended that Mitosol not be used in women who are pregnant or who may become pregnant.
Pregnancy and Pain

Mitosol Medication Information

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