News Feature | January 8, 2014

Pradaxa Being Reevaluated By FDA

Source: Pharmaceutical Online

By Cassandra Leger

Pradaxa (dabigatran), a relatively new anticoagulant used to treat non-valvular atrial fibrillation is being reassessed for safety by the FDA.  Pradaxa is a fixed dose medication that is given twice daily and competes with Coumadin (warfarin), a more commonly used anticoagulant. Patients on Coumadin must have their blood monitored regularly, whereas Pradaxa does not require therapeutic monitoring.

The FDA plans to test the various results of patients taking Pradaxa (Boehringer Ingelheim) and patient results of warfarin to see how they differ. While Pradaxa is a popular choice over warfarin, it has risks and side effects. Dose adjustments must be made for patients experiencing severe kidney dysfunction, the drug cannot be prescribed to patients who have mechanical prosthetic heart valves and, according to the FDA, the medication does not have a designated antidote. Coumadin, on the other hand, does have an antidote, vitamin K, which can be injected to counteract its effects.

These issues with Pradaxa have spurred lawsuits and online help centers.  However, there are also similar lawsuit websites for Coumadin

The manufacturer, Boehringer Ingelheim, is undeterred by the moderate bad press Pradaxa has received in the states.  Currently, they are running a new clinical trial for use of the drug in acute deep vein thrombosis and pulmonary embolus; which will be conducted on patients over the age of 21. The clinical trial will divide the test group up in subgroups according to age and sex. Despite the FDA contraindicating Pradaxa for patients with mechanical heart valves back in December of 2012, Boehringer Ingelheim is confident in their product.

Alternative medications for non-valvular atrial fibrillation would include rivaroxaban (Xarelto) and apixiban (Eliquis).  Xarelto was studied in comparison to warfarin in the ROCKET-AF Trial and was found to be non-inferior to Coumadin in preventing thromboembolic stroke in patients with non-valvular atrial fibrillation.  In the ARISTOTLE Trial, Eliquis was found to be superior to Coumadin in preventing thromboembolic stroke in patients with non-valvular atrial fibrillation.  Neither of these medications have a known reversal agent nor do they require laboratory monitoring.