Pradaxa is a relatively new anticoagulant drug made by the drug company Boehringer Ingelheim Pharmaceuticals. It was approved by the FDA in 2010, but was quickly discovered to be linked to serious side effects.

Pradaxa is also known by the generic name dabigatran, and is one of a class of drugs called Direct Thrombin Inhibitors.

When the blood thinner Pradaxa was approved in 2010, it was touted as superior to an existing blood thinner, Coumadin, also known by the generic name warfarin. The advertised advantages of Pradaxa over Coumadin were that the drug required less monitoring than Coumadin to be effective.

Pradaxa was supposed to work just as well as Coumadin with less doctor supervision, no change in diet needed, and was supposed to be more convenient because it was designed to be taken as a once-daily dose as opposed to a twice-daily dose as was necessary in the case of Coumadin.

However, reports of patients experiencing internal bleeding while taking the blood thinner Pradaxa made experts worry that the advantages of the drug were better for the drug’s marketing than they were for patient safety. Some scientists worried that not enough research had been done to ensure that taking a single dose of the drug was safe.

Allegedly, the once a day dosing of Pradaxa can cause a dramatic spike in medication amount in a person’s body, in contrast to the lower spikes in medication amount caused by the twice a day dosing of Coumadin.

Though all blood thinners come with a risk of internal bleeding, scientists worry that the large spike in the medication amount caused by the once a day dosing can cause a patient to be overly susceptible to internal bleeding. Because the patient can have a large amount of medication in their body at one time when taking the blood thinner Pradaxa, if a patient does suffer an internal bleed, that bleed can be severe and can be difficult to stop. In some cases, such severe internal bleeds can be fatal.

In the case of patients taking Coumadin, doctors could control an internal bleed by flushing the patient’s system with vitamin K, which counteracts the effect of Coumadin. Once the Coumadin was neutralized, then their blood could clot normally and the bleed could be stopped.

Unfortunately, vitamin K does not have the same antidote effect on the blood thinner Pradaxa. A Pradaxa antidote, Praxbind, was recently approved by the FDA. But for Pradaxa’s first five years on the market, there was no drug available that could counteract its anticoagulant effect in cases of dangerous internal bleeding.