Pradaxa stroke drug can be deadly

Serious side effects of Boehringer's drug Pradaxa

03/11/2011

After the Japanese Ministry of Health had already complained in August that the pharmaceutical manufacturer Boehringer Ingelheim had not sufficiently informed about the risks of the drug Pradaxa, the pharmaceutical company now warns in a recent communication expressly against the potentially fatal consequence of the use of the drug.

As Boehringer Ingelheim explained, the drug Pradaxa must not be used in stroke patients for stroke prevention, because of serious health problems, including the death of patients. Worldwide, 50 people are said to have died from the serious side effects of the drug. Those affected were bleeding profusely internally after taking the anticoagulant. To exclude further deaths, the pharmaceutical company has explicitly warned against the use of Pradaxa for stroke prevention in atrial fibrillation.

Serious side effects and deaths from Pradaxa
The drug developed by Boehringer Ingelheim and contained in Pradaxa „dabigatran etexilate“ has been approved worldwide for the follow-up of hip joint operations since 2008. Pradaxa is used over a period of about ten days after surgery. However, as so often used resourceful physicians, the anticoagulant effect of Pradaxa for other purposes, such as for stroke prevention. Patients were treated with Boehringer medication on a long-term basis to reduce their blood clotting and minimize the risk of stroke (anticoagulants to prevent strokes). A lucrative business for Boehringer Ingelheim, as stroke prevention is one of the fast-growing medical care sectors. However, doctors and patients often did not follow the recommendations of the drug manufacturer Boehringer, who explicitly advised against the use of the drug in patients with kidney hypofunction or recommended a significantly reduced dose in the user information. Numerous patients around the world had to be medically treated for the serious side effects that Pradaxa had caused them. Not infrequently, the supposedly stroke-preventive medication ended in death. Particularly in Japan, particularly many patients suffered from significant side effects of the Boehringer drug, but also in Germany were already reported deaths due to the use of Pradaxa.

Warning is to avert harm to patients
Because in patients with kidney disease, the drug can not be degraded in the body or only significantly slowed down. Accordingly, the anticoagulant remains significantly longer in the organism and over time, the blood clotting is completely suppressed. Internal bleeding with a potentially fatal outcome is the result. A permanent medication with Pradaxa is therefore urgently advised against. Although Boehringer Ingelheim has long been aware of the risks of Pradaxa, the company has so far pursued the strategy of establishing the drug as a preventive agent for strokes, with a patient target group identified as having cardiac arrhythmias and atrial fibrillation. However, the pharmaceutical company now has to rethink this strategy. To avert harm to patients, Boehringer was committed to issuing a warning about the potentially fatal health risks of the drug Pradaxa, based on the Pharma Code of the Federal Association of the Pharmaceutical Industry and the Association of Research-Based Pharmaceutical Companies. For Boehringer Ingelheim this is a serious setback, because the hope of a comprehensive use of Pradaxa in the billion dollar business of stroke prevention seems to have died. The estimated market value of Boehringer's drug, estimated by health economists at around $ 20 billion, should be correspondingly lower. (Fp)

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Image: BirgitH (picture does not show the described drug)