Do not stop taking Pradaxa anticoagulant on your own
As became known at the weekend, instead of the 50 previously added, at least 260 people have died after taking the anticoagulant drug Pradaxa with the active ingredient dabigatran. In a message, the pharmaceutical company Boehringer Ingelheim warns against unauthorized withdrawal of the drug. Patients should consult their treating doctor beforehand. If patients are well attuned, there is no reason to withdraw, said a spokesman for the company.
Pradaxa should not be discontinued on your own Since March 2008 to November 2011, according to media reports, at least 260 people have died after taking the drug Pradaxa. Pharmaceutical circles had previously said that the drug had claimed only 50 lives worldwide. Now, however, the pharmaceutical manufacturer Boehringer Ingelheim also confirmed the probable number of cases, but refused to report critically. Although there are suspected cases, the drug as such is "effective" and does not unduly endanger patient safety. After all, all medicines used to prevent thrombi can lead to unwanted internal bleeding. According to a company spokesman, patients who are currently taking Pradaxa should under no circumstances end the treatment on their own. If a correct dosage is prescribed, there is effective protection against possible strokes. In addition, in the opinion of the pharmaceutical company, the mode of action is better than with the drugs that previously acted similarly. Numerous concerned patients are currently calling Boehringer Ingelheim, as Andreas Barner, spokesman for the company management, said. With the right dosage, however, there are no concerns. "There is no reason for well-adjusted patients to stop taking Pradaxa," said Barner.
Deaths in Germany and Europe Der Spiegel reported at the weekend that 21 people had died in Europe after taking it. Four people fell victim to the drug in Germany alone. At the beginning of November, the magazine “Zeit” reported that 50 people worldwide had died of internal bleeding after ingestion. The pharmaceutical giant only confirmed "reported cases" in this context. However, the company did not publish exact numbers of cases at this time. At the time, a spokesman emphasized that individual case examinations are still ongoing, the results of which are still pending. At the weekend, Boehringer Ingelheim confirmed that around 260 people died between March 2008 and November 2011 after taking the active ingredient dabigatran. In addition, there are another 80 suspected cases. Serious bleeding had also occurred in the patients. However, the respective causes of death have not yet been confirmed or are unknown.
Regulatory authority sees no reason to act Pradaxa has been authorized across the EU since 2008 and is administered as a preventive measure against blood clots after knee and hip joint surgery. The patient target group expanded again in 2011 to include patients with cardiac arrhythmias. The active ingredient is also used here to minimize the risk of a stroke. The highest supervisory authority, the Federal Institute for Drugs and Medical Devices (BfArM), sees no need for action despite the reports available. After all, the risks have been known for a long time, as spokesman Maik Pommer said on Sunday. According to reports from the Japanese Ministry of Health about internal bleeding resulting in death, the manufacturer was asked to send red-hand letters to doctors. Special warnings were installed in it to draw attention to possible risks. The pharmaceutical manufacturer complied with this demand without hesitation.
The letter to the doctors says that the kidney function of the patient should be checked before the drug is administered. If the patient suffers from kidney dysfunction, Pradaxa should not be used or only in low doses. If there are kidney disorders, the drug is only slowly absorbed by the body. As a result, the active ingredient remains in the body for a longer time, so that blood clotting is considerably disturbed. In the worst case, there is a risk of a complete failure of the blood to clot, causing the affected person to experience internal bleeding.
Federal Institute for Drugs wants to continue to monitor Pradaxa The Federal Institute for Drugs and Medical Devices emphasized that not every reported suspected case actually has to be connected with taking Pradaxa. However, the drug will continue to be closely monitored, just like any other drug is permanently under review. Despite the prevailing knowledge, the Federal Institute is not planning any special steps.
Bleeding also with alternative medicines
Marcumar, along with warfarin, belongs to a different class of active substances than dabigatran and has been on the market for decades. There is also a risk of internal bleeding here. In contrast to Pradaxa, there are antidotes to enrichment in an emergency. (sb)
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