Authored by Chris Schroeder
DrugRisk has learned that the FDA is planning a new, widespread review of data from patients taking Pradaxa to determine if the popular blood thinning medication has greater risks for internal bleeding or blood clots than standby warfarin.
The move comes less than a year after the agency assured consumers that Pradaxa is as safe as warfarin, despite conflicting reports from many top health organizations.
The patient advocates at DrugRisk aren’t surprised at the FDA’s about-face, as the agency is dominated by former drug-industry executives and contributions from the very companies it is tasked with regulating.
News of the study also comes as the latest court records show nearly 2,000 patients or their families have filed Pradaxa lawsuits over internal bleeding injury or death.
Pradaxa was introduced in 2010 as an alternative blood thinner for patients with atrial fibrillation to prevent blood clots and stroke. Since the traditional medication warfarin requires regular blood testing, doctors and patients swarmed to the easier-managed Pradaxa.
However, drug maker Boehringer Ingelheim didn’t initially inform consumers that, unlike warfarin, Pradaxa has no antidote to stop internal bleeding in cases of emergency.
As a result, Pradaxa has been among the most widely reported drugs in recent years to the FDA for bleeding injuries and death. It has also been accused of causing 5 times the risk of death and 55% higher risks of blood clots.
Now, Forbes is reporting that the latest study will use the FDA’s Sentinel reporting database, which draws from 100 million patients, to again examine risks.
As Pradaxa has grown to blockbuster popularity with earnings of over $1 billion and prescriptions in over 70 countries, so have legal problems. Pradaxa lawsuits over internal bleeding in the U.S. have been consolidated to a special federal multidistrict litigation court.
At last report in December, the court counted 1,936 pending lawsuits. Judge Herndon, who presides over the Pradaxa MDL, also recently fined Boehringer nearly $1 million for failure to produce or preserve important data on the drug’s development and marketing.
If you or a loved one have suffered internal bleeding after taking Pradaxa, it is important to speak with a lawyer today about your rights to file a lawsuit. You may be entitled to substantial compensation, however, time is limited.
Due to the specialized nature of these cases, DrugRisk only recommends lawyers who have already handled Pradaxa lawsuits. Contact us today for more information on Pradaxa, or to speak with a lawyer.