Pradaxa Lawsuit Lawyers
Please note: Our law firm no longer accepts Pradaxa cases.
Pradaxa is a blood thinning medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), commonly known as irregular heartbeat. Since being approved by the Food and Drug Administration in October of 2010, Pradaxa (dabigatranet exilatemesylate) has been prescribed to more than a million patients. In its first year, serious safety concerns arose, prompting the FDA to review the drug’s safety. In November 2011, Pradaxa manufacturer Boehringer Ingelheim confirmed reports of 260 fatal bleeding cases worldwide that had occurred in a period of three years. These fatal bleeding incidents reinforce similar cases reported to the FDA.
Matthews & Associates no longer accepts Pradaxa cases.
Increased Bleeding Risk, No Anecdote
The FDA is evaluating post-market studies to see if Pradaxa — a new generation anti-coagulant — may be linked to an increased risk of severe bleeding episodes. The FDA communicated to the public in Dec. 2011 that it was examining whether or not Pradaxa led to more sever bleeding episodes than would be expected for any other anti-coagulant. The agency also noted that all anti-coagulant drugs carry a risk of severe bleeds. Unlike another widely used blood thinner, excessive and serious bleeding associated with Pradaxa has no readily available antidote; consequently, the bleeding events could potentially kill certain susceptible patients.
Pradaxa Recall Information
Pradaxa’s creator, Boehringer Ingelheim — which maintains offices in Missouri, Virginia and Ohio — continues to market Pradaxa despite FDA concerns that it may raise the risk of serious bleeding. If and when Pradaxa is recalled from the market, we will post that information here; so please stay tuned to this web site.
If you or a loved one has experienced adverse “side effects” from the use of Pradaxa, you may qualify for compensation to help with the cost of your medical expenses, as well as your pain and suffering. To contact a Pradaxa lawyer for a free consultation, call Matthews and Associates toll free: 1-888-520-5202.
FDA Warnings for Pradaxa
In December 2011, the FDA initiated an investigation into reports of serious bleeding events associated with Pradaxa. The agency is currently evaluating post-market studies which appear to suggest the anti-coagulant Pradaxa may raise the risk of serious bleeding events in comparison with similar anti-coagulant drugs.
FDA communications note that Pradaxa’s label warns of significant and sometimes fatal bleeds. In its Dec. 2011 communication, the agency also notes that in an 18,000-patient trial which compared Pradaxa and Warfarin, major bleeding events occurred at similar rates. The agency appears to be erring on the side of Pradaxa as of this date, for other studies have suggested Pradaxa is responsible for more bleeding events than Warfarin.
The FDA’s main focus on Pradaxa is now 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.
What is Pradaxa?
Pradaxa is a medication approved by the FDA to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), wherein the two small upper chambers of the heart beat irregularly and too fast. One can live with atrial fibrillation — with an arrhythmic heart — but the problem can also lead to chronic fatigue, heart failure and stroke.
- has no generic name at this time (2012)
- contains the active ingredient dabigatran
- was originally approved in Oct. 2010
- is manufactured by Boehringer Ingelheim
- is approved the reduction of stroke risk in patients with non-valvular atrial fibrillation (AF)
Off –label Uses of Pradaxa
Despite severe side effects related to Pradaxa, many users take the drug for–
- prevention of blood clot formation in people with heart valve disease
- blood clot treatment or prevention in people undergoing surgeries
- blood clot treatment or prevention in cancer patients
- treatment or prevention of deep vein thrombosis
- treatment or prevention of pulmonary embolism (PE), a blood clot in the lungs.
Pradaxa Side Effects
While Pradaxa can be effective in the treatment of atrial fibrillation, side effects associated with the drug are often severe and sometimes life threatening. They include:
- Indigestion or heartburn
- Stomach pain or discomfort
- Gastroesophageal reflux disease (GERD)
- Digestive track ulcers
- Frequent and/or heavy nosebleeds
- Major bleeding/Life-threatening bleeding
- Bleeding in the brain
- Heavy menstrual bleeding
- Difficulty breathing or swallowing
- Joint pain or swelling
- Bleeding from the gums
- Pink or brown urine or red or black stool
- Unusual bruising or bleeding
- Coughing up blood or bile
FDA Alerts for Pradaxa
In Dec. 2011, the FDA released a safety communication about whether or not Pradaxa causes more bleeding events when compared with similar anti-coagulant drugs. The FDA stated that all patients taking Pradaxa should be closely monitored for severe symptoms such as excessive bleeding.