Fetal Risk
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8 - methoxypsoralen (Uvadex®)

D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. This drug can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Group 6

Ausreichende Erfahrungen über die Anwendung beim Menschen liegen nicht vor. Der Tierversuch erbrachte Hinweise auf embryotoxische/teratogene Wirkungen.

Insufficient data are available on use in humans. Indications of embryotoxic/teratogenic effects were observed in animal experiments.

B2

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.