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In fact, this article is only about a leaflet. So piece of paper that you can fold so hard again and that most people barely read. The piece of paper on which, according to law, all that has to be found is what a drug can cause at worst in body. Often re are things that are very, very unlikely and which have potential to panic individual people quite nicely.
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So this is ticket. More specifically, that of Iberogast, a herbal tincture that is advertised with healing power of nature and can still be harmful. And here it becomes more fundamental. It is also a question of a toothless drug authority and a pharmaceutical company, which, with its insane blockade attitude, is damaging to itself and its credibility. An attitude that was abandoned only with death of a patient.
Iberogast, distributed by Bayer, is to help against stomach ailments. The group is to take 120 million euros annually with bitter, brown drops, which are purely vegetable. Something that Bayer actively promotes: “The combination of 9 medicinal plants works quickly and effectively.” Bayer knows that a good part of German according to surveys places great importance on taking herbal or gentle medications. The problem with this is that vegetable and gentleness cannot be equated simply.
Schöllhammer Herb can harm pregnant women and people with liver
One of nine herbs contained in Iberogast, according to Bayer, is Schöllhammer herb. In high doses it leads to liver failure and could be dangerous for breastfeeding, pregnant women and ir unborn children. For this reason, Federal Institute for Pharmaceuticals and Medical Devices (BfArM) already 2008 a step procedure against schöllhammer herb-containing medicinal products. Drugs with high content of herb had to be completely off market. In case of medicines that contained little schöllhammer herb, such as Iberogast, manufacturers had to include at least warnings that breastfeeding, pregnant women and people with liver problems should avoid drug. All manufacturers followed, only company Steigerwald, which Iberogast manufactured and later was bought toger with product of Bayer. She – and later Bayer – refused and contradicted portrayal of BfArM. The reason: Iberogast was not a pure schöllhammer herb preparation, but a combination preparation and its potential health risks could not judge BfArM due to lack of data.
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As a result, Federal institute remained seemingly undone. It did not choose to force Iberogast manufacturer to accept instructions immediately. And in this stalemate it has remained for almost ten years. On request, press spokesman of Bfarm Maik Pommer announces that Bfarm could not have taken action against Iberogast between 2008 and 2017, because it would have been inferior to Steigerwald or Bayer on basis of case reports at time in a legal dispute. Thus, opposite of measures deemed necessary by BfArM would have been achieved: decision of 2008 would have lapsed and safety instructions contained rein had been completely out of world. Therefore, BfArM collected furr information on harmfulness of Iberogast. Only 2017, according to Pommer, would have been equipped with four case reports on health damage by Iberogast, including a liver failure after ingestion (American Journal of Gastroenterology: Sáez-González, 2016), for a lawsuit and rejected almost Bayer’s dormant opposition in past ten years.
But Bayer still complained (Time reported online). The procedure continues to this day. This week, however, group unexpectedly announced that Bayer “BfArM changes in technical and usage information ordered in risk assessment procedure for Iberogast at urging of BfArM”. The reason: A patient who had taken Iberogast should have suffered a liver failure and ultimately died of it. Bayer subsequently threatened BfArM with an immediate execution.
