May 19 2022

Classification of the active ingredient vidarabine


Risk level in pregnancy: This medicine is classified as Category C.

There are no adequate studies of the effect of this drug in pregnant women, so it has not been established the efficacy and safety of medication use in pregnant women. Only seem justified its use in pregnant women if the potential benefits outweigh the potential risks to the fetus.

Vidarabine not available in many European countries. However, in the form of ointment or ophthalmic ointment is still available in other markets.

This drug, administered systemically is teratogenic in laboratory animals. The application in 10% of rabbit skin surface ointment to the concentration of 10% produce fetal abnormalities in this animal species. However, the application of 2% of the skin surface produced not fetal anomalies in experimental animals.

Based on these data, it can be concluded that the risk of a pregnant woman who received the ophthalmic application of vidarabine is rather remote in view of the low solubility of the drug and the reduced dose.

Update 31.07.2009

Meaning of category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.