“With the power of nature against stomach and intestinal complaints”: the pharmaceutical company Bayer advertises the popular stomach medicine Iberogast. It is one of the best-selling non-prescription medicines in Germany. For some years the Drug is suspected to cause liver damage.
In 2018 a woman in Germany died of liver failure and internal bleeding after she had been taking Iberogast. Now, the Cologne public Prosecutor determined according to the “Handelsblatt”, whether the death could have been prevented if Bayer had earlier warned of the side effects. A request from the MIRROR at the Cologne public Prosecutor’s office has so far remained unanswered. Consumers are unsettled.
How dangerous is the plant mean?
Iberogast is an alcoholic extract of nine herbs, including celandine, which is also used in Chinese medicine. Many consumers of herbal medicines in General-tolerated and low risk. This is not true, however. Like all other medications, even herbal remedies can have side effects. Celandine, for example, in rare cases, cause liver damage.
The competent Federal Institute for drugs and medical devices (Bfarm) requested in 2008, the then-Iberogast-manufacturer Steigerwald to provide the package insert with warnings. This is initially refused, as well as Bayer, after the group had taken over the Mediterranean.
It is only since the event of death, in the year 2018 has become known, is possibly related with Iberogast, warns Bayer in the package leaflet: “In the application of celandine containing medicines are addiction cases of liver damage (increase of liver enzyme values, Bilirubin up to drug-induced yellow (medicinal-toxic Hepatitis) as well as cases of liver failure) occurred.”
How high is the risk?
Since 2008, officially 115 suspected cases have been documented any side effects in connection with Iberogast in Germany. The cases In which the Drug was actually for the complaints to be responsible, is unclear.
Sure is, that celandine can cause herb-containing drugs liver damage. However, as with all of the side effects is the dose it comes. As critical, the value of alkaloids which are also found in greater celandine to apply.
In 2008, all the funds lost, the approval, which contained a daily dose of more than 2.5 milligrams of these substances. In the case of the recommended daily amount of Iberogast in patients according to Bayer, only 0.3 milligrams of total alkaloids. The group argued, therefore, that of Iberogast is only a minimal risk.
Who should not use Iberogast oral?
- Patients suffering from a disease of the liver, have overcome these or other liver-damaging medications, should avoid Iberogast.
- Also, for Pregnant, or Nursing, the agent is not suitable.
- Who noticed signs of a liver injury should discontinue the drug immediately and go to the doctor. Symptoms include yellowing of the skin or eyes, dark urine, discoloured stools, pain in the upper abdomen, Nausea, loss of appetite, fatigue:.
- Iberogast for more than four weeks will be taken should be examined by a doctor, the liver values.
The intake is for other patients safe?
Also, Doctors are divided. “Iberogast is not a harmless juice, but an effective drug,” says Frank Tacke, Director of the Hospital for Hepatology and gastroenterology at the Charité hospital in Berlin, in front of the MIRROR. Without a medical diagnosis, it should not be taken.
According to Tacke, however, is still unclear, such as celandine damages in rare cases, the liver. Possibly the metabolism of the Affected react differently to the agent than usual. Patients without liver disease may take Iberogast continue to, if it relieves your symptoms. In addition, the application should be monitored by a physician, in order to detect rare side effects in a timely manner.
Bernd Mühlbauer, Director of the Institute for pharmacology, Klinikum Bremen Mitte, doubted the Benefits of Iberogast. In many cases, the risks in the relationship were too high.
“The data for the effectiveness of Iberogast is not convincing,” says Mühlbauer, who also sits in the drug Commission of the German medical Profession. At the same time there is clear evidence that the agent may have life-threatening side effects. The drug Commission Iberogast no longer recommends.
In any case, patients with persistent should stomach or intestinal problems, consult promptly with a physician, advises Mühlbauer. In any case, the patient should be treat on weeks, even with Iberogast, before you go to a physician. “The best solution would be,” says Mühlacher, “if Bayer in Iberogast dispense with celandine and a methodologically good study on the effectiveness of the new product would perform.”
In summary: The drug Iberogast against stomach and intestinal discomfort is suspected to damage the liver. People with liver disease should not take it, therefore, as well as Pregnant and lactating. The drug Commission of the German medical Profession Iberogast is no longer recommended for other patients.