Pradaxa Lawsuits
Elevated Risks of Internal Bleeding and Death from Pradaxa
Pradaxa is an anti-coagulant used in patients with heart valve problems or who have atrial fibrillation. This group is at an elevated risk for stroke. Boehringer Ingelheim, the makers of Pradaxa, claim the drug is 35% more effective at reducing that risk than the more traditional medication, warfarin. They do not, however, sufficiently emphasize that Pradaxa has been linked to cases of fatal bleeding worldwide.
To date, there have been 21 cases of Pradaxa-related bleeding deaths in Europe and 14 in Japan, with an additional 225 instances in other countries. Unfortunately, no specific statistics exist for similar cases in the United States. According to data from Boehringer Ingelheim, the deaths occurred from March 2008 through October 31, 2011.
No Pradaxa Recall, But Mounting Evidence
No recall has been issued for Pradaxa, but the drug is under investigation by health regulators in the U.S. and abroad. Anyone who has taken Pradaxa and who has experienced hemorrhaging as a result may be eligible to file a Pradaxa lawsuit to seek compensation for damages. Specifically, Pradaxa has been linked to:
- internal bleeding,
- bleeding in the gastrointestinal (GI) tract,
- brain hemorrhages,
- and kidney bleeds.
While bleeding is often a risk with anti-coagulant medications, that risk is higher and more serious with Pradaxa.
History of Pradaxa
Pradaxa was originally approved for use by the U.S. Food & Drug Administration in October 2010 and is one of a class of drugs called "direct thrombonin inhibitors." Basically these drugs limit the action of a key blood enzyme integral to the clotting process.
Because Pradaxa is excreted from the body via the kidneys, high levels of the drug can remain in circulation in instances of improper kidney function. The higher the levels of Pradaxa in the body, the greater the chance of serious internal bleeding. There is no antidote for this bleeding, so the hemorrhaging is particularly serious.
In a clinical trial conducted by RE-LY, data suggested that about 16.4% of people who take Pradaxa will experience an internal hemorrhage. The label on the medication itself warns against a higher rate of GI bleeds with Pradaxa 150 mg. The risk of a fatal bleed is much higher in patients age 75 or older.
Some Symptoms of Internal Hemorrhaging
The symptoms of internal bleeding may include, but are not limited to:
- an overall feeling of lethargy,
- unusual levels of bruising,
- urine that appears brown or pink,
- stools that are black and tarry or actually red,
- coughing up blood in varying amounts,
- vomiting material that has the appearance of coffee grounds,
- bleeding from the gums or nose,
- headaches,
- swelling and weakness in the extremities,
- swelling or pain in the joints,
- and dizziness.
Investigations of Pradaxa Underway
On December 8, 2011 the FDA said that it believes Pradaxa delivers important health benefits when used as directed, but that reports of hemorrhaging were being investigated. Patients taking Pradaxa were cautioned not to discontinue the drug without consulting their physicians.
The European Medicines Agency, in October 2011, issued a warning to doctors about prescribing Pradaxa to patients older than 75 or those with known renal impairment. If Pradaxa is used with the latter, annual kidney checks are imperative.
In August 2011, Japanese authorities asked Boehringer Ingelheim to issue a Pradaxa warning after 81 of 64,000 elderly patients on the drug experienced excessive hemorrhaging. Fourteen of those patients died.
Seek Legal Help for Pradaxa Bleeding Claims
If you or any member of your family has taken Pradaxa and suffered serious bleeding or death as a result, it is in your best interest to consult a qualified personal injury attorney. Only be securing proper legal advice can you determine if you have a valid claim for compensation for injury and associated damages.
