Fetal Risk

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 3

Bei umfangreicher Anwendung am Menschen ergab sich kein Verdacht auf eine embryotoxische/teratogene Wirkung. Der Tierversuch erbrachte jedoch Hinweise auf embryotoxische/teratogene Wirkungen. Diese scheinen für den Menschen ohne Bedeutung zu sein.

There was no suspicion of embryotoxic/teratogenic effects after extensive use in humans. Indications of embryotoxic/teratogenic effects were observed in animal experiments. These appear to bear no significance for humans.

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 have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

Active Ingredient Index

desogestrel