First confirmed death by Iberogast celandine

Celandine medicinal product: Bayer must adapt Iberogast package leaflet

The chemical and pharmaceutical company must supplement the leaflet for its gastrointestinal agent Iberogast after a death. The celandine drug may now no longer be taken by pregnant women, nursing women and patients with liver disease.

Leaflet will be extended after death

As reported by the Federal Institute for Drugs and Medical Devices (BfArM), the pharmaceutical company Bayer "implements the changes to the Specialist and Use Information for Iberogast ordered by the risk assessment process at the urging of the BfArM." In the future, the herbal medicinal product may no longer be pregnant or breastfeeding after a death Women as well as patients with liver diseases are taken.

After a death, Bayer has to adapt the leaflet for his gastrointestinal remedy Iberogast. The drug should no longer be taken by pregnant women and liver patients. (Image: benjaminnolte / fotolia.com)

Herbal active ingredient

Iberogast contains the active substance celandine (Chelidonium majus). It is a poppy plant that often grows on roadsides, fences and garden weeds.

Celandine acts as a herbal painkiller anticonvulsant on the gastrointestinal tract and on the bile ducts.

Iberogast is therefore used, among other things, for complaints such as stomach pain, bloating, irritable bowel or heartburn.

Medicament must not be taken by pregnant women and liver patients

According to a statement from Bayer, Iberogast's user information will in future contain the following information:

"Iberogast® should not be taken if you have or have a history of liver disease or if you are taking medicines with liver damaging properties."

And under the section Special care when taking Iberogast is required, "if signs of liver damage (yellowing of the skin or eyes, dark urine, discolored stools, upper abdominal pain, nausea, loss of appetite, fatigue) occur, you should stop taking Iberogast ® Immediately stop and see a doctor. "

Further, under the section on pregnancy and lactation: "Iberogast® should not be taken by pregnant and lactating women."

Furthermore, the Iberogast® Specialist Information and Use Information is extended by the statement that cases of liver damage have occurred in products containing celandine.

Case of liver failure ended fatally

Triggers for the changes are new BfArM-known side effects reports of liver damage in connection with the use of Iberogast.

Among them, according to the Institute, a second case of liver failure with liver transplantation, which 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 makes the order for immediate enforcement by the BfArM superfluous, which otherwise would have been required and issued in the light of the information now available."

If, contrary to expectation, the marketing authorization holder fails to fulfill its obligations, the BfArM will continue to do so. (Ad)