Medicinal benefits versus risk in Pradaxa

Federal Institute certifies the stroke drug a positive benefit-risk ratio

11/18/2011

After numerous media reports in recent days, the deadly side effects of the stroke drug Pradaxa with the drug Dabigatran thematized, the Federal Institute for Drugs and Medical Devices (BfArM) currently checks whether actually all deaths in this country are the account of the drug from the pharmaceutical company Boehringer Ingelheim go.

In four of the five deaths, a causal relationship with the use of the stroke drug can be safely assumed, the fifth fatality is still being examined whether this is related to the use of the oral anticoagulant Pradaxa, according to the BfArM. Despite the recorded death toll, the authority goes from one „continue to be fundamentally positive“ Benefit-risk balance of the controversial drug. At the beginning of November, there were reports that 250 people worldwide had died of internal bleeding in the gastrointestinal tract or brain after taking the drug dabigatran. Critics accused the pharmaceutical company that the number of those actually affected likely to be much higher.

Internal bleeding from stroke medication
However, according to the Federal Institute for Drugs and Medical Devices, complications such as internal bleeding in oral anticoagulants are not new and only the risks and benefits should be weighed up against each other. Thus, the then registration study (RE-LY) clearly showed that the active ingredient compared to the current standard drug warfarin has clear advantages. Thus, Pradaxa has better protected from strokes than warfarin and much less often triggered the life-threatening internal bleeding. The benefit-risk ratio for Pradaxa is correspondingly more favorable than for warfarin, the BfArM explained. However, this only applies if the inclusion and exclusion criteria of the study are taken into account, according to the restriction of the Federal Institute. However, this does not always seem to be the case, although the manufacturer Boehringer Ingelheim also makes a clear reference to the risks associated with use outside the recommendation. Exclusion criteria for the use of Pradaxa primarily include severe impairment of renal function, according to the statement in the approval study and the reference by Boehringer Ingelheim in a so-called Rote-Hand-Brief, to which the BfArM commits the pharmaceutical concern in view of the health risks would have.

Customized security measures for prescribing Pradaxa
To ensure that patients do not suffer from impaired kidney function, according to the adjusted specialist information, physicians are now required to thoroughly check their patients' kidney function before prescribing the stroke drug, according to the latest BfArM communication. In addition, the treating physicians are encouraged to do so, „in high-risk patients, e.g. in patients over 75 years of age, in whom kidney function may be impaired“, To carry out a close-knit, after clinical course, control of kidney function, reports the Federal Institute for Drugs and Medical Devices in its current press release. The President of the BfArM, Prof. dr. Walter Schwerdtfeger, according to the media interest is currently „It is urgently necessary for patients to be informed about possible health risks of Pradaxa“, However, it is urgently advisable to discontinue the medication without authorization. Because this could lead to an increased risk of life-threatening thromboembolic events such as strokes or pulmonary embolism. Patients should therefore discontinue Pradaxa only after consulting their doctor, according to the warning of the Federal Institute for Drugs and Medical Devices.

Although not all of the reported deaths are linked to the stroke drug safely, it is „It is undisputed that massive risks exist if the use of the medicinal product is not carried out with the necessary care“, stressed the President of the Federal Institute for Drugs and Medical Devices. Therefore, according to the statement of Prof. Dr. med. Walter Schwerdtfeger the consistent implementation of the already launched in October on the way security measures by the manufacturer and the treating physicians particularly important, „To identify high-risk patients at an early stage, to receive treatment appropriate to the risks, or to exclude them from treatment with Pradaxa if necessary“ can be.

Application risks at Pradaxa neither more serious nor more frequent
According to the BfArM, the four deaths in Germany, which have so far been proven to be associated with Pradaxa, are not a particular accumulation and the data available to date indicates this, „that Pradaxa's application risks are neither more common nor more severe than those of other medicines used in the same treatment“, so the statement in the current press release of the BfArM. The Federal Institute points to suspected cases of Marcumar, which is used relatively frequently in Germany, in which 73 cases of suspected deaths due to hemorrhage have been reported over the past ten years. This is an average of seven deaths per year, which means a significantly higher risk than Pradaxa (reported between four and 16 deaths per year in Marcumar). However, according to the statement of the BfArM, the informative value of the reported suspected cases anyway only limited, as this is voluntary statements of suspicion of doctors (so-called „Spontaneous reporting system“) and these are only partially comparable with each other. Because „According to experience, suspected cases of new drugs such as Pradaxa are reported more frequently than in the case of long-established medicinal products such as Pradaxa. the anticoagulant Marcumar, which was approved in the mid-fifties and frequently used in Germany“, emphasized the Federal Institute for Drugs and Medical Devices in its current press release.

According to the BfArM, the fact that the reported death toll from Pradaxa is far higher in the USA and Japan than in Germany is primarily attributable to the differences between the use of Pradaxa in this country and Japan and the USA. A clear increase in the message in Germany, according to the experts is not necessarily to be feared. The different risk factors and the different concomitant medications make a comparison on the international level virtually impossible. With regard to the heart attack and coronary syndrome risks currently being discussed in the US and Europe by Pradaxa and similar drugs, the Federal Institute for Drugs and Medical Devices merely stated that „the competent authorities also these questions“ check and „inform about the progress of knowledge“ become. (Fp)

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Picture: Rita Thielen