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Tobramycin Inhalation Solution and Pregnancy

Although research has not been done on using tobramycin inhalation solution in pregnant women, the active ingredient in the drug has been shown to cause kidney problems when given as an injection. Even so, tobramycin inhalation solution may be prescribed during pregnancy if the benefits outweigh the risks.


Can Pregnant Women Use Tobramycin Inhalation Solution?

Tobramycin inhalation solution (Bethkis®, Tobi®) is a prescription antibiotic used in the management of cystic fibrosis. It is a pregnancy Category D medicine, which means it could harm an unborn child.

What Is Pregnancy Category D?

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 D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
Tobramycin inhalation solution has not been adequately studied in pregnant women or animals. The active ingredient in the medicine (tobramycin) did not appear to cause birth defects when given to pregnant rats and rabbits as an injection. It did, however, cause kidney problems in both the mother rats and the unborn rats when given to the mother rats in high doses.
Tobramycin belongs to a group of medicines known as aminoglycosides. All aminoglycosides can cause damage to the inner ear, which could lead to hearing loss. Another aminoglycoside (streptomycin) has been reported to cause irreversible deafness in children whose mothers were treated with the drug while pregnant.
It is important to note that tobramycin inhalation solution is inhaled into the lungs, and very little of the medicine is expected to reach the bloodstream with normal use. Therefore, it may not be associated with the same risks as intravenous tobramycin. In addition, based on studies that have looked at the possible effects of taking aminoglycosides during pregnancy, the overall risk that the medication will cause deafness in an unborn child is thought to be small.
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