Two years after a death in connection with the gastrointestinal drug Iberogast, the Cologne public prosecutor is investigating two former Bayer employees. The authority is examining an initial suspicion of negligent homicide in one case and negligent bodily harm in ten cases against the two former responsible persons at Bayer Vital, based in Leverkusen, said senior prosecutor Ulrich Bremer on Wednesday.
It will be determined whether the two suspects were not fulfilling their duty of care and whether there was no warning about possible liver damage printed on the package insert for the drug. It is also checked whether consumers suffered damage to their health as a result of taking the drug. The investigation would “take a long time to complete,” it said from the public prosecutor.
The patient died in the hospital
The background to this is the case of a 56-year-old patient who may have suffered from liver problems in 2018 from taking Iberogast and who died in 2018 from complications from a complex liver transplant in the Leipzig University Hospital.
A Bayer Vital spokeswoman said at the request of the “Kölner Stadt-Anzeiger” that the company was in contact with the responsible authorities: “We ask for your understanding that we do not provide any further information on ongoing legal proceedings.”
The herbal medicine Iberogast has been on the market for six decades. It came into the Bayer portfolio in 2013 when the pharmaceutical company took over Steigerwald, a Darmstadt-based specialist for herbal medicines. For the Leverkusen-based company, it is a bestseller in the non-prescription drug business. However, after the death, which is now being investigated, became known, sales of the herbal medicine fell in the high single-digit range.
Bayer does not comment on the amount of sales with Iberogast, according to information from the pharmaceutical industry service Insight Health, it was around 120 million euros in 2018. According to the 2018 annual report, that would be slightly more than two percent of revenues in this group segment.
Quarrel has been going on for a long time
However, there has been a dispute about the risks of liver damage in pregnant women and breastfeeding mothers when taking Iberogast for much longer: the Federal Institute for Drugs and Medical Devices (BfArM) had already requested warnings in the package insert in 2008. The reason was possible side effects of the ingredient celandine, which is contained in the preparation in addition to lemon balm and chamomile. At that time, a connection between liver damage and celandine was suspected in 50 cases, but these could also be assigned to other medicinal products.
Steigerwald was therefore obliged to warn of risks in the package insert. But the group successfully took legal action against the decision of the BfArM. It was not until 2018, after years of litigation and the takeover by Bayer, that the warning became mandatory. Until then, the package insert only warned of other side effects such as rash, itching or difficulty breathing.
In October, Bayer will be launching an Iberogast variant without celandine under the name Advance and will adapt the packaging design.
Source: Kölner Stadt-Anzeiger – Kölner Stadt-Anzeiger by www.ksta.de.
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