Pradaxa Safety Results Questioned by Researchers
Clinical trials used to establish the safety and effectiveness of Pradaxa, a new blood thinner, are being questioned by Canadian researchers.
In a letter published in the Therapeutics Initiative (pdf), researchers from the University of British Columbia write that the clinical trials used to gain approval for Pradaxa, known as RE-LY, were fundamentally flawed. They indicate that the drug should have never been approved based on the trial’s results.
The RE-LY clinical trials compared the effects of Pradaxa with warfarin, a blood thinner that has been on the market for decades. The trial used a double-blind method comparison between two doses of Pradaxa, but a non-blinded comparison between Pradaxa and warfarin allowed bias and errors to creep into the results, according to the letter. The clinical trials found that warfarin carried a higher risk of mortality and hospitalization over Pradaxa.
Did You Know?
Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.Learn More
The researchers concluded that Pradaxa was prematurely approved and that it is unsafe to use for many patients. They also determined that an independent audit of the RE-LY clinical trials needs to look at irregularities in conduct, bias and some of the trial’s findings.
Pradaxa (dabigatran) was only released in October 2010, but has received more consumer complaints to the FDA’s MedWatch adverse event reporting system than 98.7% of the other drugs on the market.
Some patients and doctors report that the drug sometimes had too much of an effect on clotting, leading to hemorrhages. Other reports indicate that at times it does not have enough of an effect, resulting in pulmonary embolism or deep vein thrombosis.
According to a report by the Institute of Safe Medication Practices (ISMP), the FDA received hundreds of complaints about problems from Pradaxa within weeks of its release. Most of the cases were bleeding problems in elderly users. Overall, the FDA received 307 complaints about Pradaxa side effects in the last quarter of 2010, compared to 202 complaints involving warfarin.
DanielOctober 26, 2011 at 12:43 am
I have been useing Plavix since December of 2009 when I had a Stint put into the back of my heart, Just today my Cardioligist took me off of Plavix, and put me on Pradaxa, I do not understand the change, and I do not feel safe after reading about Pradaxa, I have had A-Fib for over 50 years, and have not had an incident in over 8 years, I have been takeing Diltiazem 240 mg., all this time. I am pre[Show More]I have been useing Plavix since December of 2009 when I had a Stint put into the back of my heart, Just today my Cardioligist took me off of Plavix, and put me on Pradaxa, I do not understand the change, and I do not feel safe after reading about Pradaxa, I have had A-Fib for over 50 years, and have not had an incident in over 8 years, I have been takeing Diltiazem 240 mg., all this time. I am presently 80 years old, my question is, Is this a safe change?
"*" indicates required fields
More Top Stories
Eight women have filed Uber sexual assault lawsuits, claiming the rideshare service failed to protect them from predatory drivers due to its lack of safety measures.
A new report highlights how many women and families feel left out of Camp Lejeune settlement negotiations after suffering repeated miscarriages they say were caused by miscarriages on the North Carolina military base.
A Bard Infuse-A-Port lawsuit claims a piece of a failed port catheter broke off, causing a woman to suffer a pulmonary embolism which has resulted in fragments of the device remaining in her heart.