New reports have linked Pradaxa with risk of hemorrhages. The report was published in Journal of Neurosurgery. The report also suggests that there is no antidote to reverse the side effect of bleeding occurring due to Pradaxa. Pradaxa is deemed as safer and more effective oral anticoagulants compared to Warfarin through clinical trials.

Pradaxa is an anti clotting drug containing Dabigatran as its main active ingredient. It belongs to direct thrombin inhibitor group of drugs. It was introduced by Boehringer Ingelheim in October 2010 as a superior alternative to Warfarin for prevention of strokes in patients of atrial fibrillation. It is prescribed to patients of heart disorder for prevention of blood clots and hence reducing the risk of stroke. Blood clots could also travel to heart or lungs and could cause serious complications. Thus Pradaxa is used to reduce risk of blood clotting and other related serious health complications.

The study was conducted by Department of Neurosurgery, University of Utah. The case study was of an 83 year-old patient. The patient was prescribed with Pradaxa after he suffered a fall. He had a minor injury in head and doctor gave him Pradaxa as a blood thinner. The patient later died due to brain hemorrhage. This hemorrhage was attributed to use of Pradaxa.

The patient suffered an extreme hemorrhage six hours after having Pradaxa. There is no antidote to reverse bleeding due to Pradaxa, thus he died due to extreme bleeding in brain. Bleeding due to other blood thinner could be checked by a dose of Vitamin K.

Doctors attending the patient said that the patient was fully alert in the initial period of treatment. He was responding to queries of doctor. His neurological exam also has no serious findings. The initial CT scan showed small superficial areas of hemorrhage in his brain. He showed progressive Hemorrhage within two hours. Doctors tried to stop the hemorrhaging through intravenous fluids and a protein called recombinant factor VIIa. But nothing proved effective and the patient went into coma and ultimately died.

FDA’s Adverse Event Reporting System during the first quarter of 2011 also revealed more cases of hemorrhages due to use of Pradaxa. A report by the Institute for Safe Medication Practices in January 2012 also suggests same fact. Around 500 cases of Pradaxa bleeding has been reported. It is far too much compared to Warfarin and other such drugs.

There are speculations that 35 percent to 60 percent of Pradaxa could be removed from blood through dialysis. Researches are in progress related to this option. But Pradaxa is said be more dangerous in elderly patients. They are more prone to fall and are likely to have brain hemorrhage even from a minor trauma. Risk increases as they are prescribed Pradaxa as a blood thinner.

Though clinical trials suggests that patients on the highest dose of Pradaxa had a similar rate of brain hemorrhage as patients taking Warfarin. But risk with Pradaxa is higher as there is no reversing agent for bleeding due to Pradaxa. Pradaxa is said to have decreased chances of strokes in patients of heart ailments.

There may be many lawsuits filing in future against Boehringer Ingelheim related to Pradaxa brain hemorrhage as the manufacturer has not given adequate warning against serious and potentially life-threatening health problems associated with Pradaxa.