August 2012 Pradaxa News

News from a recent study regarding Pradaxa:  

Patients taking the new anti-clotting drug Pradaxa have a 33% higher risk of heart attack or severe symptoms ofheart disease than do patients taking warfarin.

The finding, from Cleveland Clinic researchers Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD, is based on data from seven clinical trials that enrolled 30,514 patients.

"The risk of [heart attack] or acute coronary syndrome is increased with [Pradaxa] compared with various control treatments, which include adjusted-dose warfarin, [Lovenox], or placebo," Uchino and Hernandez conclude.

Acute coronary syndrome -- acute symptoms of seriousheart disease -- is usually caused by the rupture of a plaque in a heart artery.

http://www.cbsnews.com/8301-500368_162-57356568/study-higher-heart-attack-risk-from-pradaxa/

Here is an abstract from the JAMA Archives of Internal Medicine: 

Background  The original RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) trial suggested a small increased risk of myocardial infarction (MI) with the use of dabigatran etexilate vs warfarin in patients with atrial fibrillation. We systematically evaluated the risk of MI or acute coronary syndrome (ACS) with the use of dabigatran.

Methods  We searched PubMed, Scopus, and the Web of Science for randomized controlled trials of dabigatran that reported on MI or ACS as secondary outcomes. The fixed-effects Mantel-Haenszel (M-H) test was used to evaluate the effect of dabigatran on MI or ACS. We expressed the associations as odds ratios (ORs) and their 95% CIs.

Results  Seven trials were selected (N = 30 514), including 2 studies of stroke prophylaxis in atrial fibrillation, 1 in acute venous thromboembolism, 1 in ACS, and 3 of short-term prophylaxis of deep venous thrombosis. Control arms included warfarin, enoxaparin, or placebo administration. Dabigatran was significantly associated with a higher risk of MI or ACS than that seen with agents used in the control group (dabigatran, 237 of 20 000 [1.19%] vs control, 83 of 10 514 [0.79%]; OR_M-H, 1.33; 95% CI, 1.03-1.71; P = .03). The risk of MI or ACS was similar when using revised RE-LY trial results (OR_M-H, 1.27; 95% CI, 1.00-1.61; P = .05) or after exclusion of short-term trials (OR_M-H, 1.33; 95% CI, 1.03-1.72; P = .03). Risks were not heterogeneous for all analyses (I² = 0%; P ≥ .30) and were consistent using different methods and measures of association.

Conclusions  Dabigatran is associated with an increased risk of MI or ACS in a broad spectrum of patients when tested against different controls. Clinicians should consider the potential of these serious harmful cardiovascular effects with use of dabigatran.

Use of Pradaxa/Dabigatran Leads To Increased Complications

In 2011 the FDA received more safety reports about dabigatran than any other drug. The data notes that since the bleeding complications of dabigatran are well known and physicians are more likely to report adverse events associated with new drugs, there may be more safety reports. 


 Dabigatran was the subject of  3,781 serious adverse events reported to the FDA in 2011. This included 542 patient deaths and 2,367 hemorrhages. Warfarin  was the subject of  1,106 serious adverse events, including 72 deaths.


Read more here: http://www.forbes.com/sites/larryhusten/2012/06/07/dashboard-store-posts-all-posts-add-new-categories-tags-copy-a-post-media-links-pages-comments-feedbacks-polls-ratings-appearance-users-tools-settings-collapse-menu-help-screen-options-ed/

March 2012 Pradaxa Georgia News: Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events

Pradaxa® (dabigatran etexilate mesylate) is a direct thrombin inhibitor anticoagulant, which became FDA-approved on October 29, 2010. 

Pradaxa® reduces the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Pradaxa® is being prescribed and used to replace existing successful blood thinners like Warfarin (Coumadin), the main agent used in the United States.

Anticoagulants reduce blood clotting, which is why they are more commonly called blood thinners. Anticoagulants like Pradaxa® are most commonly used in patients with atrial fibrillation, or an irregular heartbeat. This is because atrial fibrillation increases the risk of stroke, which is many times higher in patients with an irregular heartbeat.

Here is what the FDA had to say:

 

 (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

BACKGROUND: Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

RECOMMENDATION: At this time, FDA continues to believe 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.
Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.

Atrial fibrillation (AF or A-fib) is the most common cardiac arrhythmia (irregular heart beat). It may cause no symptoms, but it is often associated with palpitations, fainting, chest pain, or congestive heart failure. AF increases the risk of stroke; the degree of stroke risk can be up to seven times that of the average population, depending on the presence of additional risk factors (such as high blood pressure). It may be identified clinically when taking a pulse, and the presence of AF can be confirmed with an electrocardiogram (ECG or EKG) which demonstrates the absence of P waves together with an irregular ventricular rate.

In AF, the normal regular electrical impulses generated by the sinoatrial node are overwhelmed by disorganized electrical impulses usually originating in the roots of the pulmonary veins, leading to irregular conduction of impulses to the ventricles which generate the heartbeat. AF may occur in episodes lasting from minutes to days ("paroxysmal"), or be permanent in nature. A number of medical conditions increase the risk of AF, particularly mitral stenosis (narrowing of the mitral valve of the heart).

 http://en.wikipedia.org/wiki/Atrial_fibrillation