Pradaxa Side Effects Under FDA Investigation

Pradaxa/ Blood Clots/ Blood ThinnersPradaxa Side Effects – FDA Update

In December of 2011 the FDA conducted an investigation of reports of patients using Pradaxa in order to see if the rate of serious side effects is greater than first projected by the manufacturer.

Pradaxa, a blood thinner, became available in the U.S. in October 2010.  It is used to reduce the risk of stroke in patients with non-valvular atrial fibrillation.  It is marketed as being safer than traditional blood thinners, like warfarin (brand names Coumadin, Marfarin and Jantoven).   It also does not react with certain foods the way warfarin does, which reduces the likelyhood of  bleeding events.  Since Pradaxa thins blood, bleeding events can be extremely dangerous to patients.

In November of 2011 Pradaxa manufacturer, Boehringer Ingelheim, reported 260 cases of fatal bleeding cases that had been attributed to using Pradaxa.  They were clear to state that the rate was still below the projected rate in their clinical trial. However, there have been enough reports that the FDA put Pradaxa on their FDA MedWatch email alert in early December 2011.

Boehringer Ingelheim and the FDA are working together to analyze the post-market reports.  It is complicated with the many factors that influence the reports, such as the length of time the drug has been on the market, whether or not the adverse side effect is detailed on the drug label, and the rate at which adverse effects are reported.  The FDA is also examining the reports looking for evidence of inappropriate dosing, use of interacting drugs, and other clinical factors that may lead to bleeding.

Pradaxa Has No Antidote for Traumatic Bleeding

Traumatic hemorrhaging from Pradaxa is potentially deadly.  Unlike traditional blood thinners that Pradaxa was meant to replace, serious bleeding can not be stopped by the administration of vitamin K.  There is no simple antidote for Pradaxa bleeding.

The elderly are much more vulnerable to hemorrhaging from Pradaxa.  There are a couple reasons for this.  First, they are more likely to suffer from balance problems, arthritis and other disorders that put them at a greater risk of a fall which results in bleeding.  Also, older people’s kidneys may not filter as efficiently and the drug may stay in their system longer.  Dialysis can clear the drug from their system and may be prescribed for patients needing to stop serious bleeding.

In March 2012, a case study in the Journal of Neurosurgery showcased the deadly dangers of Pradaxa traumatic hemorrhaging in an elderly patient. The report detailed the ultimate death, of an 83-year-old man at the University of Utah Medical Center. In the begining, the patient’s case appeared to be that of a minor fall. Initially the patient was awake and alert, and his neurological exam produced no concerns. CT scans revealed only small, superficial areas of hemorrhaging in his brain.

Unfortunately, within a few hours of arriving at the hospital, new scans showed extensive intracranial hemorrhaging. Doctors administered IV fluids and a protein called recombinant factor VIIa to stop his brain bleeding, but nothing worked. Dialysis was also considered to clear the Pradaxa from his system, but his condition deteriorated too quickly. The man went into a deep coma, and passed away shortly after.

FDA Advises Pradaxa Users

Patients with AF are advised not to stop taking Pradaxa without discussing it with their healthcare professional.  The risk of stroke is greatly increased with the abrupt stopping of blood thinners.  Strokes can cause serious and permanent disability and even death.

The FDA will continue to communicate any drug safety information concerning Pradaxa when it becomes available.

Pradaxa Sales Skyrocket

On a side note Pradaxa is reported to have made Boehringe Ingelheim $831 million from February 2011 to February 2012.   Board member Hubertus von Baumbach said in a statement. ”The launch of Pradaxa is among the most successful market introductions in the pharmaceutical industry in the past few years.”

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