Pradaxa stroke medication can be fatal

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Severe side effects of the Boehringer drug Pradaxa

After the Japanese Ministry of Health had already complained in August that the pharmaceutical manufacturer Boehringer Ingelheim had not given sufficient information about the risks of the Pradaxa drug, the pharmaceutical company now expressly warns in a recent message about the potentially fatal consequences of using the drug.

As Boehringer Ingelheim explained, the drug Pradaxa should never be used to prevent stroke in high-risk patients, as there is a risk of serious health problems and even death. Worldwide, 50 people are said to have died of the serious side effects of the drug. After taking the anticoagulant, those affected bleed to death internally. To rule out further deaths, the pharmaceutical company has expressly warned against the use of Pradaxa for stroke prevention in atrial fibrillation.

Severe side effects and deaths from Pradaxa The active ingredient "Dabigatranetexilate", which was developed by Boehringer Ingelheim and contained in Pradaxa, has been approved since 2008 for follow-up care of hip joint operations worldwide. Pradaxa is used over a period of around ten days after the operation. However, as is so often the case, resourceful doctors used the anticoagulant effect of Pradaxa for other purposes too, for example to prevent stroke. The patients were treated permanently with the Boehringer drug to reduce their blood clotting and thus minimize the risk of a stroke (anticoagulants protect against strokes). A lucrative business for Boehringer Ingelheim, since stroke prevention is one of the rapidly growing areas of medical care. However, doctors and patients often did not adhere to the recommendations of the drug manufacturer Boehringer, who explicitly advises against using the drug in patients with renal insufficiency or recommends a significantly reduced dose. Numerous patients worldwide had to receive medical care because of the serious side effects Pradaxa had caused them, and the supposedly preventive stroke medication often ended in death. Especially in Japan, a particularly large number of patients suffered significant side effects from the Boehringer drug, but deaths from taking Pradaxa have also been recorded in Germany.

Warning is designed to avert patient harm because in patients with kidney disease, the drug cannot be broken down in the body or can only be broken down significantly. Accordingly, the anticoagulant remains in the organism significantly longer and over time the blood clotting is completely prevented. Internal bleeding with a potentially fatal outcome is the result. Permanent medication with Pradaxa is therefore strongly discouraged. Although Boehringer Ingelheim has long been aware of the risks of Pradaxa, the company has always followed the strategy of establishing the drug as a preventive measure against stroke, with people with cardiac arrhythmias and atrial fibrillation being cited as the patient target group. However, the pharmaceutical company now has to rethink this strategy. In order to avert harm from the patients, Boehringer felt obliged, based on the pharmaceutical code of the Federal Association of the Pharmaceutical Industry and the Association of Researching Pharmaceutical Manufacturers, to issue a warning about the potentially fatal health risks of the drug Pradaxa. This is a serious setback for Boehringer Ingelheim, because the hope of extensive use of Pradaxa in the billion-dollar stroke prevention business seems to have died. The market value of the Boehringer drug, estimated by health economists at around $ 20 billion, is likely to collapse accordingly. (fp)

Read on:
Deaths from stroke drug Pradaxa?
Anticoagulants protect against strokes

Image: BirgitH / (image does not show the drug described)

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