Hundreds of deaths from drug dabigatran

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Drugs: Hundreds of deaths from drug dabigatran (Pradaxa)

According to the European Medicines Agency (EMA), the blood thinner dabigatran is said to have cost the lives of over 250 people instead of the 50 deaths previously granted by the drug manufacturer. A few weeks ago, health authorities around the world had warned against taking the drug if patients suffer from kidney dysfunction.

Dabigatran with the active ingredient dabigatran etexilate is administered in tablet form and is better known in Germany under the trade name "Pradaxa" from the manufacturer Boehringer Ingelheim. The drug has still been approved in the European Union since 2008 and has been used to prevent blood clots after surgery on knee and hip replacements and since 2011 to prevent stroke in patients with atrial fibrillation to reduce the risk of apoplexy. The pharmaceutical company hoped to replace the popular drug “Marcumar” by introducing the drug. The pharmaceutical manufacturer believes in a billion dollar business with the drug. According to the latest worrying reports, it is questionable whether Dabigatran can actually contest the position.

More deaths than admitted by the manufacturer In recent weeks, Boehringer Ingelheim has admitted individual deaths by administration in certain health constellations. An inquiry by the news magazine "Der Spiegel" to the European Medicines Agency has now revealed that around five times as many people worldwide have died as a result of subsequent complications due to the complications that the pharmaceutical manufacturer has previously admitted. According to the authorities, 256 patients had died by the beginning of November. A total of 21 deaths had occurred in Europe due to the drug Pradaxa. At least four people died in Germany after administration. According to the magazine "Zeit", the group from Germany admitted only 50 fatalities in public.

Red hand letters sent to doctors in October At the end of October 2011, Boehringer Ingelheim had to send so-called “red hand letters” all over Europe. The letter was addressed to medical professionals who were warned against prescribing the medicine to patients whose kidneys are not functioning properly. Patients with kidney disease cannot and only very slowly break down the active pharmaceutical ingredient in the body. The result is that dabigatran etexilate remains in the organism for significantly longer and blood clotting is considerably disturbed. In the worst case, blood coagulation completely stops, causing internal bleeding with a potentially fatal consequence. Accordingly, a permanent intake should be avoided, as doctors now advise.

In August 2011, the Japanese Ministry of Health accused the pharmaceutical company of not providing enough information about the possible health risks. At that time, at least 81 patients had severe bleeding. To date, a total of 14 people have died in Japan after severe internal bleeding. As a result, the Ministry asked the company to provide better information about side effects and risks. Authorities had 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 report in its current edition reports. However, experts concede that the agent inhibits coagulation so massively that it leads to the named internal bleeding. However, this would still have to be examined clinically.

Pradaxa approved since 2008 The drug for the prevention of thrombi after surgery and since 2011 for stroke prevention in patients with cardiac arrhythmias (atrial fibrillation) has been approved by health authorities. The manufacturer hopes to replace the drug Marcumar and thus generate international business in the billions. Due to the demographic change and the increased occurrence of coronary events, the patient target group is also increasing continuously. The active ingredient of the old type had already given the pharmaceutical industry around five billion dollars in sales. While there is an antidote in Marcumar's medical emergency, there is no antidote for the anticoagulant dabigatran. Up to the summer of this year, the value of the active ingredient was titled 20 billion euros. (sb)

Read on:
Pradaxa stroke medication can be fatal
Deaths from stroke drug Pradaxa?
Anticoagulants protect against strokes

Image: Tommy S. /

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Video: Anticoagulation Management and Difficult Cases


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