Canadian researchers from the University of British Columbia are questioning the clinical trial results which found that the drug Pradaxa was safe and effective at helping atrial fibrillation (AF) patients prevent blood clots and control their heart rhythms.
Pradaxa is a blood thinner that was recently approved by the FDA based on the results of a clinical trial called RE-LY, which compared the effects of Pradaxa to the commonly-prescribed medication Warfarin. The trial was conducted with researchers using a double-blind method of comparison between the two drugs. For the study, researchers used “two doses of Pradaxa, but a non-blinded comparison between Pradaxa and Warfarin allowed bias and errors to creep into the results,” according to Canadian researchers. What the study found was that Warfarin caused a higher death and hospitalization rate than Pradaxa did.
In the end, the researchers from the University of British Columbia had a letter published in Therapeutics Initiative that concluded that Pradaxa was approved too early and that it is not safe enough for most patients’ use. The researchers also feel that there should be an independent audit of the RE-LY clinical trials so that they can look for any possible biases and irregularities in conduct.
Before Pradaxa was approved as the newest drug to help AF patients regulate their heart rhythms, anti-arrhythmic medications like Multaq were used. The drug has since been reviewed by the FDA after patients started suffering from liver failure after taking the drug. In fact, Sanofi-Aventis, the makers of Multaq, had to halt the PALLAS study after patients started dying while taking part in a clinical trial that was meant to test Multaq being used to treat permanent AF.
If you or a loved one have suffered from liver failure after taking Multaq, contact attorney Greg Jones today for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.