All About Dabigatran(Pradaxa} Reversal in the ED

Just in case you are on this instead of warfarin, you will need to be lucid enough in the emergency room to tell your doctors what anti-clotting drug you are on.
https://www.medpagetoday.com/Blogs/EPMonthly/64573?

Agent now available for reversing new oral anticoagulant in bleeding patients

• by MedPage Today Staff
  April 15, 2017

A 67-year-old woman is brought in by EMS after she developed a severe headache at home with associated vomiting and altered mental status. Her past medical history is significant for hypertension and atrial fibrillation, for which she takes atenolol and dabigatran (Pradaxa). The patient is somnolent, and after quickly securing her airway, you send her for a stat head CT. The CT shows an intraparenchymal hemorrhage. After paging your neurosurgeon on call, you consider your options for reversal of anticoagulation. You know you need to reverse her anticoagulation, but how?
The new oral anticoagulants (NOACs) are skyrocketing in popularity, displacing warfarin as first-line anticoagulants for many patients. Dabigatran is a direct thrombin inhibitor used for stroke prevention in patients with atrial fibrillation and for treatment and secondary prevention of venous thromboembolism. Dabigatran and other NOACs have several advantages over warfarin. Their pharmacokinetics are simpler, they don't have the pesky food and drug interactions that plague warfarin, they don't require monitoring and frequent dose adjustments, and importantly, they carry a lower risk of major bleeding complications.
However, a major concern is that unlike warfarin, which can be reversed with Prothrombin Complex Concentrates (PCC) or fresh frozen plasma and vitamin K, dabigatran and the other NOACs lacked a dedicated reversal agent. This made emergency physicians and others who anticipate worst-case scenarios somewhat nervous. Although the NOACs are associated with fewer serious bleeding complications than warfarin, life-threatening bleeding can still occur. How should we manage the patient on dabigatran with an intracranial hemorrhage? Or the trauma patient who requires emergent surgery for their liver laceration who happens to be on dabigatran? Alternative reversal methods have been proposed, such as use of three- or four-factor PCC, fresh frozen plasma, or even emergent hemodialysis to remove circulating anticoagulant. However, the efficacy of these methods has been questioned, and safety concerns have been raised regarding thrombotic risk of PCC.
In October 2015 the U.S FDA approved a target-specific reversal agent for dabigatran. Idarucizumab, marketed as Praxbind, is a monoclonal antibody fragment (Fab) that binds directly to dabigatran, neutralizing its activity. It is approved for reversal of anticoagulation in patients on dabigatran requiring emergent or urgent surgery or in patients with life-threatening bleeding. Dabigatran inhibits thrombin, which catalyzes one of the final steps in the clotting cascade. Idarucizumab reverses dabigatran's anticoagulant effects by binding tightly to dabigatran with an affinity 350 times greater than thrombin, thus freeing thrombin's functionality in the clotting cascade.
Studies show that administration of idarucizumab to healthy young volunteers, older volunteers ages 65-80, and volunteers ages 45-80 with mild or moderate renal impairment resulted in complete reversal of dabigatran's anticoagulant effects within minutes without any procoagulant effects. This reversal of anticoagulation lasts 24 hours, which is an advantage over PCC, which has more transient effects. One important caveat is that there must be dabigatran in the bloodstream for idarucizumab to have any effect. Once the dabigatran is cleared by the kidney, idarucizumab will have nothing to bind to and will have no effect. It is recommended to give it if the last dose of dabigatran was in the last 24-48 hours. There may be some benefit of longer time frames in patients with renal failure, who will have a slower clearance rate of the dabigatran. Finally, since it is a monoclonal antibody, it is highly specific for dabigatran. It will not reverse the anticoagulant effects of coumadin, plavix, or other NOACs such as rivaroxaban.
The data on idarucizumab in patients who are actually bleeding or being operated on looks favorable as well. The Reversal Effects of Idarucizumab on Active Dabigatran (RE-VERSE AD) trial, a large international prospective cohort study of patients on dabigatran who receive idarucizumab either for serious bleeding or prior to an urgent surgical procedure, is still ongoing. A preliminary analysis of the first 90 patients revealed that idarucizumab rapidly and completely restored coagulation parameters in 88-98% of patients who had elevated clotting times at baseline. Among patients who underwent surgery, normal hemostasis was reported in 92%, with mild to moderate impairment in 8%. Only one of 90 patients (1%) had a thrombotic event within 72 hours of administration of idarucizumab. These data mirror the safety and efficacy data on idarucizumab from earlier human and animal studies.
Dosing
The FDA-approved dose for idarucizumab is 5 mg, which is administered as two separate 2.5 mg IV doses infused over 5 minutes. The second dose should be administered within 15 minutes of the first infusion. There is no dosing change needed for renal or hepatic impairment.
Adverse Events
Adverse reactions are rare and include headache (5%) and hypokalemia (7%). There are case reports of serious complications in patients receiving idarucizumab, including acute ischemic stroke, cardiac arrest, NSTEMI, DVT, and PE, but the incidence is thought to be extremely low.
Cautions
Contraindications include hypersensitivity to idarucizumab or any components of the formulation. Risks/benefits of anticoagulation should be considered before reversing anticoagulation with idarucizumab, since the underlying disease state may predispose to thrombotic events. However, since it is typically reserved for life-threatening bleeds, the scale typically would favor its use. Cost is also a consideration. Not all emergency departments may be able to stock idarucizumab due to the infrequent need for it and its cost.
Pregnancy
There are no studies of human or animal models of pregnancy. It is unknown if idarucizumab is excreted in breast milk.
Cost
A single 2.5 mg/50 mL dose of idarucizumab costs $2,100, so recommended treatment with two doses costs $4,200. This is slightly cheaper than four-factor PCC, which costs about $5,000 for an 80 kg patient.
Karen Serrano, MD, and Christina Shenvi, MD, are assistant professors of emergency medicine at the University of North Carolina. Shenvi authors RX Pad each month in EPM. A version of this article originally appeared at Emergency Physicians Monthly.

The authors of this column receive no funding or incentives from any pharmaceutical company, and have no conflicts of interest related to the topics of their articles. Furthermore, Praxbind is not an advertising client of Emergency Physicians Monthly.

• Primary Source

  New England Journal of Medicine

  Source Reference: Connolly SJ, et al. "Dabigatran versus warfarin in patients with atrial fibrillation" N Engl J Med 2009; DOI: 10.1056/NEJMoa0905561

• Secondary Source

  Emergency Medicine Journal

  Source Reference: Alikhan R, et al. "The acute management of hemorrhage, surgery and overdose in patients receiving dabigatran" Emerg Med J 2014; DOI: 10.1136/emermed-2012-201976.

• Additional Source

  Anesthesiology

  Source Reference: Honickel M, et al. "Prothrombin complex concentrate is effective in treating the anticoagulant effects of dabigatran in a porcine polytrauma model" Anesthesiology 2015; DOI: 10.1097/ALN.0000000000000863

New drug reverses the effects of blood thinner in patients with brain hemorrhage

If you are on the new class of blood thinners you will want to make sure all the hospitals you may ever use know about this.
http://www.alphagalileo.org/ViewItem.aspx?ItemId=160770&CultureCode=en

A new medication reverses the blood-thinning effects of the anticoagulant dabigatran in patients suffering a brain bleed, potentially limiting the extent of bleeding, according to research presented at the American Stroke Association’s International Stroke Conference 2016.
Dabigitran is prescribed to people with atrial fibrillation to prevent blood clots from forming in the heart and traveling to the brain causing a stroke.  Patients on blood-thinning drugs, such as dabigatran (Pradaxa), who suffer a type of bleeding that occurs inside the skull (intracranial hemorrhage) are at high risk of complications or disability. Idarucizumab (Praxbind) is an antibody that chemically binds and neutralizes the blood-thinning effects of dabigatran.
An interim analysis of the first 90 patients in a study called RE-VERSE AD (REVERSal Effects of idarucizumab in patients on Active Dabigatran) showed that idarucizumab effectively reversed dabigatran’s anticoagulant effects, said Richard A. Bernstein, M.D., Ph.D., lead study author and director of the stroke program at Northwestern Memorial Hospital in Chicago, Illinois.
Bernstein presented the results of 90 brain hemorrhage patients enrolled in the REVERSE-AD study. This included 11 men and seven women (average age 79).
In patients who received two 2.5-gram of idarucizumab infusions in a 15-minute period, blood tests revealed that dabigatran’s blood-thinning effect was 100 percent reversed in all 18 patients with brain bleed.
“This is definitely good news,” Bernstein said.  “Idarucizumab rapidly and completely reverses the effect of dabigatran in patients with brain hemorrhage. Once the dabigatran is reversed, we can focus on taking care of the patient without worrying about the blood thinner.”
The new results are part of a large on-going phase III study testing idarucizumab in a range of patients who take dabigatran and have dangerous bleeding or need urgent surgery or other procedures that carry serious bleeding risks.
Idarucizumab was approved by the U.S. Food and Drug Administration in October 2015 as the first medicine designed to reverse dabigatran.
Researchers say before idarucizumab was available, patients on dabigatran who needed emergency surgery were given purified clotting factors, which carry the risk of patients’ clotting systems forming dangerous blood clots.
“Idarucizumab gets rid of the dabigatran, but doesn’t seem to carry with it any tendency to increase clotting. This should make perioperative management easier and safer,” Bernstein said.
Idarucizumab’s success so far might persuade more people to take a blood thinner when their doctors recommend it. “The biggest problem we face in preventing stroke in patients with atrial fibrillation is that almost half of patients don’t take any blood thinner at all,” Bernstein said. “I see the biggest impact of idarucizumab as providing reassurance to patients that if bleeding while taking dabigatran does occur, we can quickly reverse the dabigatran. This reassurance could lead to more strokes prevented by increasing the use of an effective blood thinner.”
Co-authors are Charles V. Pollack Jr., M.D.; Jeffrey I. Weitz, M.D.; Paul A. Reilly, Ph.D.; John Eikelboom, M.B.B.S., M.Sc.; Menno V. Huisman, M.D., Ph.D.; Pieter W. Kamphuisen, M.D., Ph.D.; Jörg Kreuzer, M.D.; Jerrold H. Levy, M.D. and Thorsten Steiner, M.D., Ph.D. Author disclosures are on the abstract.
The study was funded by Boehringer Ingelheim. Praxbind and Pradaxa are both marketed by Boehringer Ingelheim of Ridgefield, Connecticut.
Additional Resources:

• Any available downloadable video/audio interviews, B-roll, animation, graphic, and images related to this news release are on the right column of the release linkhttp://newsroom.heart.org/news/new-drug-reverses-the-effects-of-blood-thinner-in-patients-with-brain-hemorrhage?preview=3526b77201c750c0e1160b975f68484c
• Video clips with researchers/authors of the studies will be added to the release link as available. 
• Follow news from ASA’s International Stroke Conference 2016 via Twitter@HeartNews #ISC16.

http://newsroom.heart.org/news/new-drug-reverses-the-effects-of-blood-thinner-in-patients-with-brain-hemorrhage?preview=3526b77201c750c0e1160b975f68484c

• Full bibliographic informationAbstract 213 - Richard A Bernstein, Northwestern Univ, Chicago, IL; Charles V Pollack, Jr., Thomas Jefferson Univ, Philadelphia, PA; Jeffrey I Weitz, McMaster Univ, Hamilton, ON, Canada; Paul A Reilly, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT; John Eikelboom, McMaster Univ, Hamilton, ON, Canada; Menno V Huisman, Leiden Univ Medical Ctr, Leiden, Netherlands; Pieter W Kamphuisen, Univ Medical Ctr Groningen, Groningen, Netherlands; Jörg Kreuzer, Boehringer Ingelheim GmbH & Co KG, Ingelheim am Rhein, Germany; Jerrold H Levy, Duke Univ Med Ctr, Atlanta, GA; Thorsten Steiner, Univ of Heidelberg, Heidelberg, Germany
  Effect Of Idarucizumab On Intracranial Bleeding In Dabigatran-treated Patients: Initial Results From RE-VERSE AD
  American Heart Association’s International Stroke Conference 2016, February 16-19, 2016, Los Angeles, California.

Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

So maybe my friend who refused to go on Pradaxa because of no reversal agent might be able to change her mind.
The trial here:
https://clinicaltrials.gov/show/NCT02104947

A discussion of preliminary results here:

NOAC Antidote Promising in Phase III Trial

Idarucizumab restored clotting in most patients on the new oral anticoagulant (NOAC) dabigatran (Pradaxa) who had serious bleeding or required urgent surgery, according to interim results of the phase III RE-VERSE AD trial.
The median maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours of administration was 100%, based on central laboratory analysis of dilute thrombin time or ecarin clotting time.

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"Idarucizumab normalized the test results in 88% to 98% of the patients, an effect that was evident within minutes," Charles V. Pollack Jr., MD, of the Pennsylvania Hospital in Philadelphia, and colleagues found.

 

Pradaxa antidote works fast, completely in small trial

And maybe we don't need rat poison anymore. The lack of an antidote was the reason a friend of mine discontinued use.
http://whtc.com/news/articles/2013/nov/18/pradaxa-antidote-works-fast-completely-in-small-trial/
An experimental antidote to the widely used blood clot preventer Pradaxa worked immediately and completely in an early-stage trial among healthy volunteers, raising hopes that the drug's blood-thinning effects can be reversed in emergency situations.
"These are absolutely exciting findings," said Dr. Stephan Glund, a research executive of privately held Boehringer Ingelheim Pharmaceuticals, the German drugmaker that developed Pradaxa and is testing the antidote.
Pradaxa, also known as dabigatran, was approved in 2010 to prevent strokes in patients with atrial fibrillation, an irregular heartbeat that affects more than 2.5 million American adults and which raises the risk of stroke fivefold. It works by blocking thrombin, a blood enzyme involved with clotting.

Pradaxa Holds No Extra Bleeding Risk, FDA Says

This is definitely for your doctor to discuss, I know there have been bleeding deaths reported and the main concern was a lack of reversal agent. Your doctor should be fluent in all this stuff, so demand an answer.
http://www.medpagetoday.com/Cardiology/VenousThrombosis/35701

They must have changed their mind from June of this year.

Report: Pradaxa tops FDA’s list for serious adverse events

Reports from both the manufacturer and direct reports pointed to 3,781 serious adverse events associated with dabigatran in the U.S. in 2011

But I'm not a medical person so I don't have any valid opinions. Ignore that person behind the curtain.

And a doctor blogging about the benefits here:

 

Pradaxa is not a bad drug

 

Report: Pradaxa tops FDA’s list for serious adverse events

Make sure you get from your doctor what to look for adverse events from Pradaxa or warfarin or statins.
http://www.cardiovascularbusiness.com/index.php?option=com_articles&view=article&id=34247:report-pradaxa-tops-fdas-list-for-serious-adverse-events
Dabigatran topped the list of direct reports to the FDA of serious adverse drug events in 2011, according to an analysis by the Institute for Safe Medication Practices. Dabigatran (Pradaxa, Boehringer Ingelheim) had the largest number of direct reports, at 817, followed by warfarin, at 490.

Reports from both the manufacturer and direct reports pointed to 3,781 serious adverse events associated with dabigatran in the U.S. in 2011, according to the analysis. Analysts identified 542 patient deaths, 2,367 cases of hemorrhage, 291 cases of acute renal failure, 644 cases of stroke and 15 cases of suspected liver failure. The FDA approved the use of dabigatran for the prevention of stroke and systemic embolism in non-valvular AF patients in 2010.

Warfarin had 1,106 cases overall in 2011, including 72 deaths. The authors noted that in past analyses, warfarin consistently ranked near the top for direct reports to the FDA.

“Two drugs that inhibit the formation of blood clots ranked first and second among all direct reports to the FDA in 2011, emphasizing that the combination of a vulnerable patient population and a powerful pharmacological action rank among the highest risks in prescription drug therapy,” the authors wrote in the report, QuarterWatch. “While a therapeutic goal of preventing strokes, pulmonary embolism, and other harm through unwanted blood clots is a worthy objective, these results demonstrate that treatment is accompanied by substantial risks.”

The European Medicines Agency (EMA) reported May 25 that its post-marketing data on dabigatran showed that the frequency of occurrence of fatal bleedings was significantly lower than what was observed in clinical trials. Nonetheless, the EMA called for an update of product information to give physicians clearer guidance on how to reduce and manage the risk of bleeding.

By QuarterWatch’s count, the FDA received 179,855 reports of serious, disabling and fatal adverse drug events in the U.S. in 2011, an increase of 9.4 percent from 2010. The majority, 88 percent, were submitted by drug manufacturers while the remaining 12 percent were submitted to the FDA by health professionals and patients.

In a section on suspect drugs linked to severe side effects in the U.S., the report listed simvastatin (Zocor, Merck) and rosuvastatin (Crestor, AstraZeneca) as first and second most frequently identified drugs linked to severe muscle damage in 2011. Simvastatin had 123 cases and rosuvastatin 73 cases. By contrast, atorvastatin (Lipitor, Pfizer) accounted for only 15 reported cases.

QuarterWatch is published by the Institute for Safe Medication Practices, a Horsham, Pa.-based nonprofit organization that monitors adverse drug events reported to the FDA. The QuarterWatch reports are funded through the institute and are based on analyses of computer excerpts that the agency releases for research use from its Adverse Event Reporting System.

Thrombosis Breakthrough May Lead To New Treatment Options

Maybe eventually a better treatment than warfarin or pradaxa.
http://www.doctortipster.com/9500-thrombosis-breakthrough-may-lead-to-new-treatment-options.html
Researchers at the Institute for Cardiovascular and Metabolic Research (ICMR) at the University of Reading, have discovered the mechanism by which platelets bind together to form blood clots. This discovery, they say, can lay the foundation for new treatments to prevent stroke or heart attacks.
In healthy people, blood is always in a physiological fluid-coagulant equilibrium. In other words, when the endothelium is damaged, platelets and fibrinogen  form a network plug that repair the defect and the bleeding stops. Then the network of fibrin is lysed and the blood vessel is recanalized. This process occurs continuously in the body. In certain diseases or conditions such hypercoagulability or atrial fibrillation, platelets aggregate together to form a thrombus that may obstruct imporant blood vessels. What researchers found is how platelets communicate with each other. It seems that platelets are interconnected by gap junctions, some pore-like structures. ‘Gap junction’ is a common type of connection to other cells, such as myocardial cells or neurons. Gap junctions are a special type of connection that  interconnects the cytoplasm of two cells.

Professor Jonathan Gibbins and Dr. Sakthivel Vaiyapuri, said: “This appears to be a very important communication mechanism for blood clotting and thrombosis”. He added that by blocking those channels involved in the formation of junctions thrombosis can be reduced. The new discovery may be a target  in antithrombotic therapy.
Currently, stroke is prevented by oral anticoagulant medication (warfarin) which inhibits the synthesis of coagulation factors dependent on vitamin K. This medication has several drawbacks. On the one hand, and patient dose should be adjusted by measuring the INR (International Normalised Ratio), on the other hand, there are plenty of side effects. Oral anticoagulants can cause bleeding and give drug interactions. It is important to note that the risk of bleeding is significantly increased when combined with anticoagulants such as clopidogrel antiplatelet or aspirin. In addition to this, anticoagulants are prohibited during pregnancy.
Anticoagulant medication is commonly prescribed in patients with cardiovascular disorders. Oral anticoagulants are prescribed long-term in patients with atrial fibrillation to prevent thromboembolic accidents. Because atria no longer contract, blood tends to clot and the formed thrombi can migrate into circulation and stroke can occur. Also, patients with metal valves need to follow long-term treatment with oral anticoagulants to prevent thrombosis.
Understanding the mechanisms underlying thrombosis may be a target for discovery of new anticoagulants. Dr. Vaiyapuri notes that this discovery is exciting even if their work is still not complete.

Minor Trauma Led to Death in Pradaxa Patient

A friend of mine was on Pradaxa for a while and she was extremely concerned about bleeding and the lack of a reversal agent.
http://www.medpagetoday.com/Neurology/HeadTrauma/31524?utm_source=cardiodaily&utm_medium=email&utm_content=aha&utm_campaign=03-07-12&eun=gd3r&userid=424561&email=oc1dean@yahoo.com&mu_id=
A dabigatran (Pradaxa) patient's death from a brain hemorrhage following a fall has again highlighted concerns over lack of an effective reversal agent for the drug.
Despite treatment with recombinant factor VII, the 83-year-old man deteriorated rapidly as the bleeding spread across most of the left hemisphere of his brain in just six hours, according to Richard H. Schmidt, MD, PhD, of the University of Utah in Salt Lake City, and colleagues.
"Imbalance and falls are common in this population, and intracranial hemorrhage resulting even from minor trauma may occur with increasing frequency as use of this drug becomes more widespread," they warned in a case report published online in the Journal of Neurosurgery.
A high index of suspicion for catastrophic hemorrhage in dabigatran users is critical so that what limited management options there are can be started without delay, the group urged.
The direct thrombin inhibitor acts at the very end of the coagulation cascade, so factor VIIa and fresh-frozen plasma don't work. Prothrombin complex concentrate hasn't been tested outside of animal models yet.
Dialysis can remove 35% to 60% of circulating dabigatran in two to three hours, but wasn't considered until too late to be effective for the reported case.
The group recommended checking the thrombin time and starting dialysis early along with judicious IV fluids to maintain renal perfusion, which is the main route of dabigatran excretion.
"Caution is necessary, however, because patients with atrial fibrillation have tenuous intravascular volume status, and fluid overload can lead to worsening heart function," they warned in the paper.
Hematologists expressed similar concerns over lack of reversibility in a recent review of a cluster of bleeding episodes in New Zealand, largely involving older patients and those with impaired renal function.
The drug was widely hailed initially for its ability to be given at a fixed dose without the need for frequent adjustments and monitoring.
In the pivotal RE-LY trial, bleeding risks were similar to those with warfarin. But since FDA approval in 2010 for stroke prevention in atrial fibrillation, reports have surfaced of a possible excess of bleeding deaths with the drug, prompting an ongoing safety review by the FDA.
Drugmaker Boehringer Ingelheim has called these reports within what would be expected based on the clinical trial, noting that dabigatran's prescribing information cites a trend for higher major bleed rates with the 150-mg dose versus warfarin in the 75-and-older population.
In the case report, the 83-year-old man had been on 150-mg twice-daily dabigatran for new-onset atrial fibrillation for one month before the ground-level fall at home that sent him to the emergency department.
On arrival, the man was alert and responsive with a normal neurological exam and a Glasgow Coma Scale score of 15. The initial CT scan showed only small, superficial areas of hemorrhage in his right temporal lobe and left temporal and parietal lobes.
Within two hours, he developed slurred speech and his neurological state began to deteriorate rapidly. Repeat CT imaging showed significant progression of right parenchymal and left frontal hemorrhages.
The neurosurgical team members knew they had limited options to reverse the blood thinner, which had left the patient with an international normalized ratio of 1.4 and a thrombin time over 150 seconds compared with the normal 15 to 20 seconds.
Despite trying a weight-based dose of recombinant factor VII for its rapid onset of action, mental status continued to slide to the point where the man lapsed into a coma (Glasgow Coma Scale score 6) and required emergency endotracheal intubation.
His final CT scan six hours after admission showed hemorrhage encompassing most of the left hemisphere and effacing the left lateral ventricle.
The patient was transitioned to palliative care after extensive discussion with his family and died shortly thereafter.
Dabigatran is only the first in a class of direct thrombin inhibitors that may raise these problems, Schmidt's group noted.
Others are on the horizon, "and these agents will likely have similar risks for catastrophic progression of traumatic injuries," they warned.

Pradaxa Benefit Outweighs Bleeding Risk, FDA Says

New news on the Pradaxa front. Quiz your doctors on this.
http://www.medpagetoday.com/Cardiology/Arrhythmias/30075?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news

The FDA has announced today that patients taking the anticoagulant dabigatran (Pradaxa) to reduce the risk of stroke associated with atrial fibrillation should continue to take the drug as directed, despite post-market reports of severe bleeding.

A report of about 50 cases of fatal bleeding worldwide associated with the drug surfaced in November.

Drugmaker Boehringer Ingelheim said at the time that dabigatran's safety profile was in line with that seen during the RE-LY clinical trial, which compared dabigatran with warfarin in more than 18,000 participants.

And the FDA noted in Wednesday's announcement that dabigatran's label contains a warning about significant and sometimes fatal bleeds, and noted that in the randomized RE-LY trial, both arms had similar major bleeding rates.

Although the agency is continuing to monitor the situation, at this time it "believes that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label."

In its statement the agency said that patients should not stop taking the drug without consulting a physician because doing so could increase the risk of stroke.

In the meantime, physicians and healthcare professionals should report any adverse events or side effects associated with dabigatran to FDA's MedWatch Safety Information and Adverse Event Reporting Program.