Bethkis and Pregnancy
Is it safe for pregnant women to use Bethkis? When the active ingredient was given as an injection in pregnant rats, it appeared to cause kidney problems in both the unborn rats and the mother rats. Before using Bethkis during pregnancy, talk to your healthcare provider about the benefits and risks in your particular situation.
Bethkis® (tobramycin inhalation solution) is a prescription antibiotic that belongs to a class of antibiotics known as aminoglycosides. It is a pregnancy Category D medicine, meaning it may cause harm to your unborn child.
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.
Bethkis is inhaled into the lungs. The drug itself has not been studied in pregnant women or pregnant animals. Tobramycin, the active ingredient, has been studied in pregnant rats and rabbits when given as an injection just under the skin (a subcutaneous injection). In these studies, the drug did not appear to cause birth defects. It did, however, cause kidney problems in the unborn rats at high doses, which also caused kidney problems in the mother rats.
Other aminoglycoside antibiotics have been associated with irreversible hearing loss in children whose mothers took the drug when pregnant. However, based on studies that have looked at the possible effects of taking aminoglycosides during pregnancy, many researchers consider the risk for hearing problems in children who are exposed to the drugs before birth to be low.