Bleeding rates linked to new use of Pradaxa (Dabigatran) are no higher than they are with new users of warfarin, says a new FDA Drug Safety communication report update (November 2, 2012).

The FDA (Food and Drug Administration) carried out an evaluation on Pradaxa after receiving several post-marketing reports of bleeding among new users.

The Agency says its investigation, which focused on bleeding occurring in the stomach and intestines, as well as bleeding in the brain (intracranial hemorrhage), among new Pradaxa versus warfarin users, found that Pradaxa's bleeding rates are no higher than warfarin's.

The FDA looked at data from insurance claims and the FDA's Mini-Sentinel pilot of the Sentinel Initiative. The results of the Mini-Sentinel assessment show that bleeding rates between the two medications are similar, and consistent with data from the clinical trials that were used during the approval process of Pradaxa (the RE-LY trial).

The Agency says it is continuing to monitor various data sources in the ongoing safety review of Pradaxa.

Medications for patients with non-valvular atrial fibrillation

Patients with non-valvular atrial fibrillation (AF) are at significantly higher risk of developing stroke and blood clots. AF is the most common heart rhythm abnormality, in which the upper chambers of the atria, in the heart, beat irregularly and rapidly.

The two most important medications prescribed to AF patients are warfarin and Pradaxa, to reduce the risk of stroke and blood clots.

While Pradaxa and warfarin are effective, they can cause potentially serious and sometimes fatal bleeding. All anticoagulant medications have this risk.

Recommendations regarding Pradaxa remain unchanged

The FDA emphasizes that Pradaxa "provides an important health benefit when used as directed." It has not altered its recommendations regarding the medication.

Doctors who prescribe Pradaxa must follow the dosing recommendations in the drug label carefully, especially if the patient has renal impairment (improperly functioning kidneys), to minimize the risk of bleeding.

If you have atrial fibrillation and are on Pradaxa, do not stop taking it before discussing with your doctor. If you stop taking the drug suddenly, your risk of stroke will increase. Strokes are potentially serious, permanently disabling and fatal events.

The FDA says it is conducting two planned, protocol-based observational assessments of Pradaxa, which assess patients and evaluate reports of bleeding. Any relevant data that becomes available on bleeding risks related to Pradaxa will be reported immediately, the Agency added.

About Pradaxa (Dabigatran)

Pradaxa (Dabigatran) was approved by the US FDA in October 2010, in capsule form for the prevention of strokes and blood clots in patients with atrial fibrillation. Pradaxa was approved the following year by EMA (European Medicines Agency), in August 2011, for AF patients who are at risk of stroke.

It was the first stroke prevention medication to be approved in 50 years for individuals with AF, according to Pradaxa markers, Boehringer Ingelheim.

Pradaxa (Dabigatran) is a thrombin inhibitor anticoagulant - it inhibits thrombin. Thrombin is a blood enzyme involved in the blood clotting process. Experts believe that it will eventually replace warfarin as the preferred anticoagulant in the majority of cases, because it does not require frequent blood tests for international normalized ratio monitoring, and offers similar efficacy results.

Pradaxa competes with Johnson & Johnson's and Bayer's Xarelto

Bristol-Myers Squibb and Pfizer Inc. have submitted Eliquis (Apixaban) to the FDA for approval. According to many Wall Street analysts, Eliquis is the most impressive of the new generation of oral anticoagulants to replace warfarin.

A Phase III clinical trial (ARISTOTLE) found that patients on Eliquis had better stroke or systemic embolism protection and less bleeding than those on warfarin. Eliquis was shown to reduce stroke or systemic embolism risk by 21%, major bleeding risk by 31%; mortality was reduced by 11%.

Some facts about atrial fibrillation

  • 5 million people are thought to suffer from atrial fibrillation in the USA, and 6 million in the European Union

  • Atrial fibrillation is the most common cardiac arrhythmia (irregular heart condition)

  • Approximately 1 in every 4 people age 40+ years in the USA and Europe are expected to develop AF

  • An AF patient has a five times greater risk of stroke than people without the condition

  • In the USA, 15% of all strokes are thought to be caused by AF

  • Half of all AF patients who have a stroke die within 12 months of the stroke. This figure is considerably higher than stroke cases among non-AF patients. 24% of AF patients die within 30 days of having a stroke

Written by Christian Nordvist