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The gastric drug Iberogast is one of the best-selling over-the-counter drugs
Photo: imago / eckphoto
The Cologne public prosecutor's office is investigating two former employees of the Bayer pharmaceuticals company because of a death that may have been linked to taking the drug Iberogast.
There is an initial suspicion of negligent homicide in one case and negligent bodily harm in ten cases, the authority announced on Thursday.
The "Kölner Stadt-Anzeiger" had previously reported on it.
In 2018, a 56-year-old woman was hospitalized in Leipzig with liver damage.
She died of complications from a liver transplant.
The woman is said to have previously taken Iberogast.
The public prosecutor is now examining whether the omission of a warning on the package insert has violated the duty of care and whether there is a causal connection with the consumption of the product and the health impairments of consumers, writes the authority.
A Bayer spokeswoman said her company is cooperating with the authorities.
"According to the current state of knowledge, there are no new medical findings that would lead to a reassessment of the facts by Bayer," she said.
Bayer also assume "that there is no established causality in connection with the side effects that have occurred in connection with the intake of Iberogast".
Iberogast is "a proven, effective and safe drug".
Iberogast is one of the best-selling non-prescription drugs in Germany.
The remedy is said to help with stomach pain, nausea, bloating, irritable bowel syndrome and heartburn.
In 2013 Bayer took over the Iberogast producer Steigerwald, and since then the Leverkusen-based company has had the stomach remedy in its portfolio.
The preparation contains celandine.
It has long been known that the alkaloids it contains can cause liver damage in rare cases.
Warning notice arranged
In 2008, all drugs whose daily dose exceeded 2.5 milligrams of these alkaloids lost their approval.
According to Bayer, patients only get 0.3 milligrams of total alkaloids with the recommended daily amount of Iberogast.
The group therefore argues that the risk of liver damage from Iberogast is minimal.
As early as 2008, the responsible Federal Institute for Drugs and Medical Devices (BfArm) asked the then manufacturer Steigerwald to provide the instruction leaflet with appropriate warnings.
Steigerwald refused.
Bayer initially stayed on this line when the company took over the funds.
The relevant notice was officially ordered in 2018.
Since then, it has been pointed out on the package insert that cases of liver damage and cases of liver failure have occurred when medicinal products containing celandine were used.
People with liver disease should generally not take the drug.
This also applies to pregnant and breastfeeding women and children under three years of age.
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wbr / dpa