Tobi Podhaler and Pregnancy
Because Tobi Podhaler (tobramycin inhalation powder) may increase the risk for kidney problems, hearing loss, and other possible complications, it may not be safe to use during pregnancy. Tobi Podhaler is usually only prescribed in this case if the benefits of using the drug outweigh the potential risks to the unborn child.
Can Pregnant Women Use Tobi Podhaler?
Tobi® Podhaler™ (tobramycin inhalation powder) is a prescription medication used in the management of cystic fibrosis. This is a pregnancy Category D medication, which means it may cause harm to an unborn child if taken when pregnant.
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.
Tobi Podhaler contains tobramycin, an aminoglycoside antibiotic. In animal studies, tobramycin did not cause birth defects when given as an injection to pregnant rats and rabbits; however, it did cause kidney problems in both the mother rats and the unborn rats.
Tobi Podhaler is an inhaled antibiotic. It is not given as an injection. This specific medication has not been adequately studied in pregnant women or in pregnant animals.
Another aminoglycoside antibiotic -- streptomycin -- has been associated with complete hearing loss in children whose mothers were treated with the drug during pregnancy. It is unknown whether Tobi Podhaler would have the same risks. However, some researchers have concluded that the overall risk for deafness in an unborn child when aminoglycosides are used during pregnancy is small.