The gastro-intestinal drug Iberogast should not be used by Pregnant, Breastfeeding and people with liver disease taken. Nothing was so far read on the pack. The Federal Institute for drugs and medical products by now, that the manufacturer adds these instructions.
Bayer has agreed to change the label of the gastro-intestinal Using Iberogast within the next four weeks. The Federal Institute for drugs and medical devices (BfArM) has confirmed.
You need to point out that they were Pregnant, Lactating, and patients are not allowed to take with liver disease the recipe. In addition, they are intended to Supplement damage to the Liver as a side effects of celandine containing products.
Receivables are to be implemented within four weeks
This decision is the result of a ten-year-old dispute. Already in 2008, was suspected of 50 cases of celandine liver promotes damage. The BfArM calls since then, to complement the package insert this note, however, without success.
The Federal Institute announced a number of additional cases suggest that the use of Iberogast leads to liver damage. Including a case from June of 2018, which ended, ultimately, fatal.
Since the Bayer group refused, so far, the additions should be decided by the administrative court in Cologne. Now, the marketing authorisation holder has to secure that he will implement the BfArM requested Changes within four weeks.