Medicines: benefit versus risk with Pradaxa

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

After numerous media reports in recent days have dealt with the deadly side effects of the stroke drug Pradaxa with the active ingredient dabigatran, the Federal Institute for Drugs and Medical Devices (BfArM) is currently examining whether all of the deaths mentioned in this country are actually attributable to the drug company Boehringer Ingelheim.

In four of the five deaths, a causal connection with the use of the stroke drug can be safely assumed, with the fifth victim, it is currently still being examined whether this is related to the intake of the oral anticoagulant Pradaxa, according to the BfArM. Despite the fatalities to be recorded, the authority assumes that the controversial drug will continue to have a “generally positive” risk-benefit ratio. At the beginning of November, figures were known that 250 people worldwide died from internal bleeding in the gastrointestinal tract or brain after taking the active ingredient dabigatran. Critics accused the pharmaceutical company that the number of people actually affected is likely to be much higher.

Internal bleeding from stroke medication According to the Federal Institute for Drugs and Medical Devices, complications such as internal bleeding from oral anticoagulants are not new and the only thing that needs to be weighed up appropriately is the risks and benefits. The approval study at the time (RE-LY) clearly showed that the active substance had significant advantages over the current standard active ingredient warfarin. Accordingly, Pradaxa provided better protection against strokes than warfarin and triggered the life-threatening internal bleeding much less frequently. The benefit-risk ratio for Pradaxa is correspondingly more favorable than for warfarin, explained the BfArM. However, this only applies if the inclusion and exclusion criteria of the study are taken into account, so the Federal Institute's restriction. However, this does not always seem to be the case, although the manufacturer Boehringer Ingelheim also clearly refers to the risks when used outside of the recommendation. The main exclusion criteria for the use of Pradaxa are severe impairment of kidney function, according to the statement in the approval study and the advice from Boehringer Ingelheim in a so-called red-hand letter, to which the BfArM commits the pharmaceutical company in view of the health risks would have.

Adjusted safety measures for prescribing Pradaxa In order to ensure that patients do not suffer from impaired kidney function, doctors are now obliged, according to the adjusted specialist information, to thoroughly check their patients' kidney function before prescribing the stroke drug, according to the latest release from the BfArM . In addition, the treating physicians are encouraged to “with risk patients, e.g. in patients over 75 years of age, in whom kidney function could be impaired, "to carry out a close clinical 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. According to Walter Schwerdtfeger, given the media interest, "factual information to patients about the possible health risks of Pradaxa is urgently required", although an unauthorized withdrawal of the drug is strongly recommended. This could lead to an increased risk of life-threatening thromboembolic events such as strokes or pulmonary embolism. Those affected should therefore stop taking Pradaxa only after consulting their doctor, the warning from the Federal Institute for Drugs and Medical Devices.

Although it is not possible to establish a connection with the stroke drug in all reported deaths, it is "indisputable that there are massive risks if the drug is not used with the necessary care," emphasized the President of the Federal Institute for Drugs and Medical Devices . Therefore, according to Prof. Walter Schwerdtfeger, the consistent implementation of the safety measures already initiated in October by the manufacturer and the treating physicians is particularly important, so that risk patients can be identified early, receive appropriate treatment for the risks, or, if necessary, treatment with Pradaxa can be excluded ”.

Application risks at Pradaxa are neither serious nor more frequent According to the BfArM, the four deaths in Germany that have so far been safely associated with Pradaxa are not particularly frequent and the data available so far indicate that “the application risks of Pradaxa are neither more frequent nor more serious than those other drugs used with the same treatment goal, ”says the statement in the current press release from the BfArM. The Federal Institute refers to the suspected cases of Marcumar, who is used relatively frequently in Germany, in whom 73 suspected cases of fatal outcome due to bleeding have been reported over the past ten years. This is an average of seven deaths per year, which speaks for a significantly higher risk than with Pradaxa (between four and 16 deaths per year were reported with Marcumar). However, according to the BfArM, the informative value of the reported suspected cases is only limited anyway, since these are voluntary reports by the doctors (so-called "spontaneous reporting system") and these can only be compared to a limited extent. Because "experience has shown that suspected cases of new medicines such as Pradaxa are reported more frequently than those that have been introduced for a long time, such as the anticoagulant Marcumar, which was approved in the mid-1950s and widely 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 number of possible deaths due to Pradaxa in the USA and Japan is far higher than in Germany is primarily due to the differences between the use of Pradaxa in Germany and in Japan and the USA. According to the experts, a significant increase in the number of reports in Germany is not necessarily to be feared. The different risk factors and the different concomitant medication make a comparison on an international level almost impossible. Regarding the heart attack and coronary syndrome risks from Pradaxa and comparable medicinal products currently being discussed in the USA and Europe, the Federal Institute for Drugs and Medical Devices merely announced that "the responsible authorities will also examine these questions" and "provide information about the progress in knowledge". (fp)

Read on:
Pradaxa: Practice test could prevent death
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Image: Rita Thielen /

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