Pradaxa: Information held back specifically?

Pradaxa: Information held back specifically?

Pharmaceutical company Boehringer Ingelheim in criticism

According to a recent article by the British Medical Journal (BMJ), the use of the blood thinner Pradaxa (manufacturer Boehringer Ingelheim) sometimes harbors considerable risks for the patient in its previous form. Here, regular checks of blood values ​​could significantly improve the safety of therapy, the authors write and associate the statement with an accusation against the pharmaceutical company: The information, on the basis of which, among other things, the drug approval authority of the United States had determined the use of Pradaxa, was incomplete, reports that "BMJ".

In the assessment of the stroke medication, the supposedly unnecessary monitoring of the blood values ​​according to the "BMJ" message played an important role, as did the option of not having to adjust the dosage individually. In the cost-benefit assessment, this made a clear advantage over the conventional stroke drug Marcumar. However, according to the BMJ article, Boehringer Ingelheim "failed to provide regulatory authorities with information about the potential benefits of monitoring and adjusting the dose."

Information withheld for marketing reasons? According to the "BMJ", Boehringer Ingelheim had known from internal investigations since 2011 that regular measurement of the plasma level of the drug and appropriate adjustment of the dosage could reduce the likelihood of severe bleeding by 30 to 40 percent compared to the well-controlled use of warfarin . It was also found that the plasma level sometimes varied considerably when taking the same dose. For marketing reasons, the pharmaceutical manufacturer decided not to publish the test results. Internal emails that became public in a legal dispute confirm that several employees of the company saw a conflict here with the market opportunities of Pradaxa (active ingredient dabigatran), reports the BMJ. Finally, the pharmaceutical company decided against announcing the test results.

Discussions about medication monitoring Before the approval of Pradaxa, according to the BMJ authors, there were discussions about the surveillance both at the Food and Drug Administration (FDA; US Medicines Agency) and at the European Medicines Agency (EMA) the medication. However, no need for monitoring was derived from the available information, and "in the end, the FDA approved dabigatran in October 2010 for use in stroke prevention in patients with atrial fibrillation without the need to adjust the dose in each patient," reports the " BMJ ". The approval was granted by the EMA in August 2011.

Elderly patients particularly at risk After the market launch, Pradaxa quickly became a success and, by April 2012, achieved blockbuster status with sales of more than one billion dollars. The Boehringer board member Hubertus von Baumbach said that "the introduction of Pradaxa has been one of the most successful market launches in the pharmaceutical industry in recent years," reports the "BMJ". However, with the sale of dabigatran, the discussion about fatal bleeding, especially in the elderly, has flared up again. In any case, they are at increased risk of bleeding, and Boehringer Ingelheim's marketing data show that "45 percent of Pradaxa patients are over 76 years of age or older," the BMJ authors write. An FDA report of all adverse events after taking Pradaxa showed that dabigatran was associated with 542 deaths and 2,367 bleeding reports, while warfarin accounted for 72 deaths over the same period. According to the authors' conclusion, fundamental doubts about the safety of therapy are appropriate and, if necessary, the requirements for monitoring and adjusting the dosage have to be corrected. (fp)

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