In animal studies, the dexamethasone part of Tobradex (tobramycin and dexamethasone) increased the risk of birth defects. Long-term use of this steroid may also increase the risk of poor fetal growth and fetal death. Because of this, Tobradex is considered a pregnancy Category C drug, meaning it may not be safe to use in pregnant women.
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 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. A pregnancy Category C medicine may be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
In studies, giving dexamethasone (the steroid component of Tobradex) in the eyes of pregnant rabbits increased the risk of birth defects by 15.6 percent to 32.3 percent. Other studies in rats have shown that long-term use of dexamethasone during pregnancy may increase the risk of poor fetal growth and fetal death.
In general, the tobramycin component of Tobradex seems to be relatively safe for use during pregnancy, at least in the very low doses that are used in Tobradex.
eMedTV serves only as an informational resource. This site does not dispense medical advice or advice of any kind.
Site users seeking medical advice about their specific situation should consult with their own physician. Click