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Clik here to view.The FDA has extended use of the blood-thinning medication Pradaxa to include patients diagnosed with or at risk of deep vein thrombosis (DVT) or pulmonary embolism (PE). The drug has been used in the United States since 2010 to prevent strokes in patients diagnosed with non-valvular atrial fibrillation. The new approval could mean many more patients will be prescribed the drug in the future, despite hundreds of reports of serious and even deadly Pradaxa side effects.
According to a press release from Pradaxa manufacturer Boehringer Ingelheim, the FDA approved the drug for patients who have been treated with a parenteral anticoagulant drug for at least five to 10 days. These types of anticoagulants, which include heparin, are faster acting drugs to prevent the formation or growth of blood clots. In addition, Pradaxa may be prescribed to patients who have previously been diagnosed with DVT or PE and risk a recurrence of their condition.
Risks of DVT and PE
DVT involves the formation of a blood clot in a deep vein of the body, often the lower leg. DVT may not occur with any symptoms, making it difficult for an individual or physician to know the condition is present. A PE occurs when the blood clot breaks loose and travels to the lung, blocking blood flow into the lung. Symptoms of a PE include chest pain, shortness of breath and rapid heart rate. It can be fatal if it is not promptly treated.
Both DVT and PE belong to a category of cardiovascular conditions known as venous thromboembolisms or VTE. VTE affects approximately 900,000 people annually. Around one-third of all cases involving a PE will have fatal consequences.
However, treating DVT and PE with Pradaxa could also carry the risk of potentially serious adverse events. Since the drug was introduced in 2010, hundreds of reports of Pradaxa side effects have concerned physicians and patients taking the drug. Reports often involve uncontrollable bleeding that has led to the death of some Pradaxa users.
When it was first introduced, Boehringer Ingelheim marketed their product as a safe and convenient alternative to the older blood-thinning medication warfarin. Unlike warfarin, Pradaxa did not require special diet restrictions or ongoing monitoring. However, patients who began bleeding on warfarin could be given vitamin K to reverse the drug’s anticoagulant effect. No such antidote exists at this time for Pradaxa, making it difficult for physicians to treat patients with bleeding events.
Growing number of Pradaxa lawsuits
Since its introduction, hundreds of injured patients have filed lawsuits against Boehringer Ingelheim, claiming the company did not provide proper warning about the potential dangers associated with their drug. More than 2,000 have been coordinated into multidistrict litigation in U.S. District Court for the Southern District of Illinois, where they are overseen by Judge David Herndon. Multidistrict litigation is used to coordinate a large number of similar cases against the same defendant, in order to streamline early trial proceedings.
The first trials in the MDL, known as bellwether trials, are scheduled to begin later this year. Bellwether trials often give attorneys and plaintiffs an idea of how juries will respond to evidence and testimony. They can also serve as a catalyst for settlement negotiations between plaintiffs and defendants. As use of Pradaxa expands to more patients, questions may be raised as to how this will effect litigation and the lawsuit number in the future.
- Medscape, FDA Approves Dabigatran for Treatment of VTE and Reducing VTE Occurrence, http://www.medscape.com/viewarticle/823159
- Formulary Watch, FDA Approves Pradaxa for Treatment, Reduction in Risk for Recurrence of DVT, PE, http://formularyjournal.modernmedicine.com/formulary-journal/news/fda-approves-pradaxa-treatment-reduction-risk-recurrence-dvt-pe?page=full
- Forbes, Boehringer Ingelheim’s Oral Anticoagulant Gains New Indication, http://www.forbes.com/sites/larryhusten/2014/04/07/boehringer-ingelheims-oral-anticoagulant-gains-new-indication/
- U.S. District Court, Southern District of Illinois, MDL No. 2385, http://www.ilsd.uscourts.gov/mdl/mdl2385.aspx
- FDA, Pradaxa (Dabigatran Etexilate Mesylate): Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events, (http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm282820.htm