The BfArM recently received numerous reports from Germany of serious adverse reactions to Angusta (misoprostol for inducing labour) when used outside the approved dosage recommendations and despite existing contraindications. One case resulted in the death of the unborn child and another in the death of the mother. Angusta may only be used in accordance with the instructions for use. In particular, the instructions on dosage, dosing intervals and certain contraindications must be observed.

To the risk information (available in German only)