Do not discontinue medication with Pradaxa

Do not expose the anticoagulant Pradaxa

11/14/2011

As announced on the weekend, instead of the previously admitted 50 now at least 260 people have died after taking the anticoagulant drug Pradaxa with the drug dabigatran. The pharmaceutical company Boehringer Ingelheim warns in a statement before an arbitrary discontinuation of the drug. Patients should first consult their attending physician. If patients are well adjusted, there would be no reason for dismissal, according to a spokesman for the group.

Pradaxa should not be discontinued on its own
Since March 2008 to November 2011, according to media reports, at least 260 people have died after taking the drug Pradaxa. Previously, it had been called from pharmaceutical circles, the funds have claimed only 50 fatalities worldwide. But now the drug manufacturer Boehringer Ingelheim confirmed the probable case numbers, but dismissed any critical reporting. Although there are these suspected cases, the drug as such is „effective“ and do not unduly compromise patient safety. Finally, it could come with all medicines, which are used for the prevention of thrombi, to unwanted internal bleeding. According to a company spokesman, patients who are currently taking Pradaxa should never stop their treatment on their own initiative. If a correct dose is prescribed, there is effective protection against possible strokes. In addition, according to the pharmaceutical company, the modes of action are better than in the previously similar acting drugs. At present, Boehringer Ingelheim is calling on many concerned patients, as Andreas Barner, spokesman for the management, said. However, given correct dosage, there are no concerns. "For well-adjusted patients, there is no reason to sell Pradaxa," explained Barner.

Deaths in Germany and Europe
The mirror had reported on the weekend that in Europe already 21 people have died after taking. Four people alone fell victim to the remedy in Germany. In early November, the magazine had „Time“ It has been reported that 50 people worldwide have died of internal bleeding after taking it. The pharmaceutical giant merely confirmed in this context „reported cases“. Exact case numbers, however, were not published by the company at this time. A spokesman at the time emphasized that individual case tests are still pending, the results of which are still pending. At the weekend, Boehringer Ingelheim confirmed that between March 2008 and November 2011, around 260 people worldwide died after taking the drug dabigatran. In addition, there are another 80 suspected cases. The patients also had serious bleeding. The respective causes of death are not yet confirmed or unknown.

Supervisory authority sees no reason to act
Pradaxa has been approved EU-wide since 2008 and is being used as a preventive measure against blood clots after surgery on knee and hip joints. The patient target group expanded again in 2011 to patients with cardiac arrhythmia atrial fibrillation. Again, the drug is used to minimize the risk of stroke. The supreme 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 some time, as spokesman Maik Pommer said on Sunday. According to reports from the Japanese Ministry of Health on internal bleeding with fatal consequences, the manufacturer has been asked to send Red Hand letters to doctors. It contained special warnings to alert them to possible risks. This requirement was complied with without hesitation by the pharmaceutical manufacturer.

Thus, the letter to the doctors states that the kidney function of the patient should be checked before administration of the drug. If the patient suffers from a renal impairment Pradaxa should not be used or only with lower doses. If there are kidney disorders, the drug will be absorbed slowly by the body. As a result, the drug remains longer in the body, so that the blood clotting is significantly disturbed. In the worst case, a complete loss of blood clotting threatens, causing the person suffering internal bleeding.

Federal Institute for Medicines wants to continue watching Pradaxa
The Federal Institute for Drugs and Medical Devices emphasized that not every reported suspected case should actually be linked to the intake of Pradaxa. However, you will continue to watch the drug closely, just as any other drug is also permanently on the test. The Federal Institute plans no special steps despite prevailing knowledge.

Bleeding also with alternative remedies
Marcumar belongs together with Warfarin to a drug class other than Dabigatran and has been on the market for decades. Again, there is a risk of internal bleeding. In contrast to Pradaxa, however, there are antidotes to the Reichung in an emergency. (Sb)

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Picture: Andrea Damm