Fetal Risk

Active Ingredient Index

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raloxifene (7)

X

Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit. This drug may (can) cause fetal harm when administered to a pregnant woman. This drug is contraindicated in women who are or may become pregnant. 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 7

Es besteht ein embryotoxisches/teratogenes Risiko beim Menschen (1. Trimenon).

There is a risk of embryotoxicity/teratogenicity in humans. (1st trimester).

X

Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.