Study Shows Pradaxa Has Higher Gastrointestinal Bleeding Risk than Warfarin
A new study conducted by the FDA shows that Pradaxa, which has been highly criticised for dangerous bleeding incidents, has been linked to a greater risk of gastrointestinal bleeding risk in patients than warfarin, a generic blood thinner.
The FDA looked at 134,000 Medicare patients, aged 65 years old and older, and found that, among those recently prescribed a blood thinner, Pradaxa put the patients at a lower risk of clot-related strokes, bleeding in the brain, and death, compared to Warfarin. However, Pradaxa patients had a higher incidence of gastrointestinal bleeding than those on warfarin.
The FDA said the new study was “based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern.” The administration added that they would continue “to investigate the reasons for differences in major GI bleeding rates for Pradaxa and warfarin observed.”
Although the study did not lead the FDA to the conclusion that Pradaxa needed a label change or a warning associated with it, many patients on Pradaxa have experienced harmful side effects because of the drug.
Pradaxa was developed to replace decades-old blood thinner warfarin, specifically to prevent strokes in patients suffering atrial fibrillation, a type of irregular heartbeat that is common in the elderly. Like other blood thinners, according to Boehringer, Pradaxa comes with a risk of potential internal bleeding. The company cited a recent study done by the US Food and Drug Administration (FDA) that Pradaxa had a lower risk of severe bleeding than other blood thinners, warfarin in particular.
However, personal injury and wrongful death lawsuits against the company, which number over 2,000 in the United States alone, state otherwise. A study performed by the Cleveland Clinic showed that Pradaxa had a 33% increased chance of suffering a heart attack or developed symptoms of heart disease, which could in turn increase potential for internal bleeding if a heart complication developed.
The FDA stated in 2012 that Pradaxa had been linked to around 1,000 deaths.
The Strom Law Firm Can Help with Injury Cases Involving Pradaxa
If you or a loved one have been prescribed Pradaxa and have suffered any of these complications:
- Unusual bleeding & hemorrhaging,
- Pink or brown urine,
- Red or black stools,
- Coughing blood,
- Vomiting that resembles blood or looks like coffee grounds,
- Bleeding from the gums,
- Regular nosebleeds,
- Joint pain & swelling,
- Weakness and swelling of the joints,
- Intestinal bleeding, and even
You may have a personal injury or wrongful death case against Pradaxa’s manufacturers.
The pharmaceutical liability lawyers at The Strom Law Firm, LLC are at the forefront of the fight to protect the public and will stand up for your rights against the big drug and insurance companies. We will fight to ensure that you and your loved ones receive the justice you deserve. Contact our defective drug and wrongful death attorneys at the Strom Law Firm, LLC today for a free consultation to discuss the facts of your case as well as your legal rights. 803.252.4800