Celandine medicinal product: Bayer must adjust the Iberogast package insert
After a death, the chemical and pharmaceutical company has to add the package insert for its gastrointestinal agent Iberogast. The celandine medicinal product can no longer be taken by pregnant women, breastfeeding women and patients with liver diseases.
Package insert will be expanded after death
As reported by the Federal Institute for Drugs and Medical Devices (BfArM), the pharmaceutical company Bayer "implements the changes in the technical and usage information for Iberogast ordered in the risk assessment process at the urging of the BfArM." Women as well as patients with liver disease.
Herbal active ingredient
Iberogast contains the active substance Greater celandine (Chelidonium majus). It is a poppy plant that often grows on the edges of the path, fences and as a garden weed.
Celandine as a herbal pain reliever has a relaxing effect on the gastrointestinal tract and on the biliary tract.
Iberogast is therefore used, among other things, for symptoms such as stomach pain, bloated stomach, irritable bowel syndrome or heartburn.
Medicines should not be taken by pregnant women and liver patients
According to a Bayer statement, Iberogast's package leaflet will contain the following information:
"Iberogast® must not be taken if you have or have had a history of liver problems or if you are also using medicines with liver-damaging properties."
And under the section Special caution when taking Iberogast is required “if there are signs of liver damage (yellowing of the skin or eyes, dark urine, discolored stool, pain in the upper abdomen, nausea, loss of appetite, fatigue) you should stop taking Iberogast ® quit immediately and see a doctor. "
Further under the section pregnancy and breastfeeding: "Iberogast® must not be taken by pregnant and lactating women."
Furthermore, the technical and usage information for Iberogast® has been expanded to include the fact that cases of celandine products have caused liver damage.
Case of liver failure was fatal
The triggers for the changes are new reports of side effects of liver damage that have become known to the BfArM in connection with the use of Iberogast.
According to the institute, this includes a second case of liver failure with liver transplantation that ended fatally.
Bayer has now "made a binding commitment to fully implement the changes to product information for Iberogast ordered by the BfArM within four weeks," the statement said.
"This eliminates the need for the BfArM to order immediate implementation, which would otherwise have been required and would have been issued in the light of the information now available."
If, contrary to expectations, the marketing authorization holder does not meet the commitments entered into, the BfArM will continue to reserve this measure. (ad)