DENVER - In August 2011, 86-year-old Ruth Shoemaker was taken to the hospital for a blood transfusion, after she became ill from severe internal bleeding. “I didn’t realize it was that bad, or could be that bad,” she said.
Her medical records show she took Pradaxa for nearly six months and she believes the medication caused her near-death.
Pradaxa was recommended by her family doctor to treat her heart problems. Shoemaker said the drug appealed to her when she was told she wouldn’t need regular check-up while on the medication, unlike other blood-thinning medications, like warfarin.
After she began taking Pradaxa, Shoemaker said she felt different, “I would get up and make breakfast, and then go back to bed,” she said. “I was always tired and I couldn’t do much of anything.”
“When I got off that, I regained some of my energy back,” Shoemaker said, never realizing the drug may cause internal bleeding.
In October 2010, the U.S. Food and Drug Administration approved Pradaxa to prevent strokes in people with atrial fibrillation.
In a news release by the FDA, Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research touted the drug and said, “Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa.”
After its approval, the FDA began a post-market review on the safety of the drug after a large number of complaints of bleeding among Pradaxa users.
In a report issued last week, the FDA found, “Bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.”
The report didn’t take into account Pradaxa’s inability to be reversed if bleeding occurs, a problem that many doctors and the manufacturer of Pradaxa admit.
“There is obviously research that is ongoing to try and develop agents to reverse the drug, they just haven’t come on the market yet,” said Dr. Peter Buttrick, head of Cardiology at university of Colorado Hospital.
Dr. Buttrick said if a patients who is on Pradaxa comes in with internal bleeding they will be required to do a blood transfusion or have dialysis to get the drug out of the system.
“The problem stems from the fact that the label never tells the user or the doctor that there’s no reversal agent for Pradaxa,” said Seth Katz, a lead attorney in the product liability suit.
Katz said Pradaxa directly inhibits thrombin - a protein involved in clotting.
It is different than Warfarin, which has a reversal agent to halt bleeding if a reaction occurs.
Katz told CALL7 Investigator Keli Rabon that once a patient starts bleeding, stopping it is almost impossible.
“If you don't get to the hospital in time, a lot of people have died from the drug,” Katz said.
In 2011, the FDA received 3,781 adverse event reports on Pradaxa. Among those, 644 people reportedly suffered strokes and 542 people reportedly died from taking the medication.
Despite the incidents, the FDA has not recalled the prescription drug. In a statement to CALL7 Investigators, FDA spokeswoman Sandy Walsh said the agency was reviewing the claims to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected.
Walsh added, “Bleeding that may lead to serious or fatal outcomes is a well-recognized complication of all anticoagulant therapies.”
Boehringer Ingelheim spokeswoman Emily Baier said in a statement that the company is fighting the product liability lawsuit.
”The FDA deemed Pradaxa to be safe and effective. It is well-known that all blood thinners carry a risk of bleeding. This risk must be balanced against an individual’s risk of stroke, which can be debilitating or potentially even fatal,” Baier wrote.
Katz said doctors were also left in the dark about the potential dangers. “The problem stems from the fact that the label never tells users or the doctors that there’s no reversal agent for Pradaxa; it’s not on the label,” Katz said.
Baier disputes Katz’s claim. “Boehringer Ingelheim has consistently communicated the benefits and risks of Pradaxa, which are clearly stated in the U.S prescribing information and medication guide that is distributed with every prescription,” Baier wrote.
Boehringer Ingelheim maintains that not only is its product safe for use based on its own clinical trials, but that the FDA also approved the drug.
Katz points out the per the FDA regulations, the federal agency doesn’t perform its own independent tests when approving a drug for use; it relies on research and clinical trials provided by the drug’s manufacturer.
Pradaxa E-mail to CALL7:
- Boehringer Ingelheim believes that the product liability lawsuits filed against the company regarding Pradaxa are without merit and we will vigorously defend each and every case.
- Pradaxa has been well-studied in more than 25,000 people worldwide, including the pivotal RE-LY® trial that enrolled more than 18,000 patients.
- The U. S. Food and Drug Administration (FDA) deemed Pradaxa to be safe and effective after reviewing the clinical trial data.
- The efficacy and safety of Pradaxa was established in one of the largest stroke prevention clinical trials ever conducted with NVAF patients.
- Pradaxa was proven 36% better than warfarin at reducing the risk of stroke in patients with NVAF.
- Neither lawsuits nor the significant advertising activities being conducted by plaintiffs’ attorneys alter the positive benefit-risk profile for Pradaxa.
- It is well-known that all blood thinners carry a risk of bleeding. This risk must be balanced against an individual’s risk of stroke, which can be debilitating or potentially even fatal.
- Patient safety and education is, and always will be, our top priority. Boehringer Ingelheim has consistently communicated the benefits and risks of Pradaxa, which are clearly stated in the U.S prescribing information and medication guide that is distributed with every prescription.
- We are confident the evidence will show that Boehringer Ingelheim acted appropriately and responsibly in the research, development, and marketing of this important medication.
- Boehringer Ingelheim is a science-based company that is proud to bring innovative products, like Pradaxa, to patients and the medical community. Our doctors and scientists worked for more than a decade to design and implement exhaustive clinical trials to bring the first novel oral anticoagulant in 50 years to patients and healthcare providers.