Hundreds of deaths from drugs Dabigatran

Medicines: Hundreds of drug deaths Dabigatran (Pradaxa)

12/11/2011

According to the European Medicines Agency (EMA), the blood thinner Dabigatran is believed to have killed more than 250 people instead of the 50 fatalities previously granted by the drug manufacturer. Already a few weeks ago, health authorities around the world had warned against taking the drug if patients had kidney dysfunction.

Dabigatran with the active ingredient Dabigatranetexilat is administered in tablet form and is better known in this country under the trade name „Pradaxa“ of the manufacturer Boehringer Ingelheim. The drug is still approved in the European Union since 2008 and is used to prevent the formation of blood clots after surgery for knee and hip replacement and since 2011 also to prevent strokes in patients with atrial fibrillation, to reduce the risk of apoplexy. The pharmaceutical company hoped that the introduction of the drug could replace the widely used drug „Marcumar“. The pharmaceutical manufacturer believes in a billion-dollar business with the means. Whether Dabigatran can actually contest the position is questionable after the last disturbing reports.

More deaths than admitted by the manufacturer
In recent weeks, Boehringer Ingelheim has granted individual deaths by administering certain health constellations. Well, by a request of the news magazine „The mirror“ The European Medicines Agency announced that about five times as many people worldwide have died from the complications of the disease than the pharmaceutical producer has previously acknowledged. According to authorities, until the beginning of November, 256 patients died after taking it. A total of 21 deaths had occurred in Europe by the drug Pradaxa. At least four people have died after being administered in Germany. According to the magazine „Time“ the group from Germany had given the public only 50 fatalities.

In October, red hand letters sent to doctors
As early as the end of October 2011, Boehringer Ingelheim had to call so-called „Red Hand Letters“ send. The letter was addressed to physicians who were warned against prescribing the medicine to patients whose kidneys have limited function. Patients with kidney disease in the body can not and only very slowly break down the drug. The consequence is that Dabigatranetexilat remains much longer in the organism and blood clotting is significantly disturbed. In the worst case, complete coagulation stops, triggering internal bleeding with potentially fatal consequences. Accordingly, a permanent intake should be strictly avoided, as doctors now advise.

In August 2011, the Japanese Ministry of Health accused the pharmaceutical company of not providing enough information about the potential health risks. At that time, severe bleeding had occurred in at least 81 patients. To date, a total of 14 people have died in Japan after severe internal bleeding. In the course of this, the ministry asked the group to better inform about side effects and risks. The authorities have also reported similar cases in New Zealand and Australia. However, it has not yet been conclusively clarified whether the drug actually caused the death of humans, as the Spiegel reports in its current issue. Experts are admitted, however, that the agent inhibits the coagulation so massive, so that it comes to the named internal bleeding. However, this would have to be investigated clinically.

Pradaxa approved since 2008
Since 2008, it has been approved by health authorities for the prevention of thrombi after surgery and, since 2011, for stroke prevention in patients with cardiac arrhythmia (atrial fibrillation). The manufacturer hopes for a replacement of the drug Marcumar and thus generate international business worth billions. Due to the demographic change and the increased incidence of coronary events, the patient target group continues to increase. Already the active ingredient of the old type had brought the pharmaceutical industry around five billion dollars in sales. While an antidote exists in Marcumar's medical emergency, there is no such anticoagulant in Dabigatran. By the summer of this year, the value of the active ingredient was titled with 20 billion euros. (Sb)

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Picture: Tommy S.