European Regulators May Join FDA in Minimizing Pradaxa Side Effects
By John Curran
Pradaxa internal bleeding side effects have not kept the prescription blood thinner from being a blockbuster medication for manufacturer Boehringer Ingelheim. While it was originally approved to prevent blood clotting for people who had joint surgery, the federal Food and Drug Administration also has approved it for use in preventing issues for those with atrial fibrillation, or an irregular heartbeat. If the European equivalent of the FDA joins in, there could be significant consequences for patients.
The study that the agencies are looking at is a retrospective study called RE-LY that focuses on long-term usage of blood thinners. However, while the FDA and the scientists in the study focus on the overall safety profile, the risk of Pradaxa cerebral hemorrhage side effects and related bleeding for specific groups bears mentioning. For patients with moderate to severe risk (five to nine on a 9-point scale), were about 25 percent less likely to have a stroke.
In that same cohort, the possibility of significant Pradaxa internal bleeding side effects was one-third higher than the generic warfarin for those taking it twice per day. Overall the bleeding rates were about equal except that warfarin caused somewhat more bleeding events when taken on a long-term basis for non-acute atrial fibrillation problems that could potentially lead to a stroke or other blood clotting issues, according to the study the FDA used.
So for many patients, Pradaxa side effects like internal bleeding or cerebral hemorrhage may be worth the risk. At best, they were about one-quarter less likely than those for the generic warfarin. However, the FDA, in approving the new usage, has omitted mention of the fact that there are no known reversal agents for Pradaxa bleeding, leading to hundreds of deaths in restricted applications.
That has led to numerous claims filed by Pradaxa lawsuit attorneys, and more are likely to come as a potential antidote for Pradaxa bleeding issues is a few years away. Potassium provides the same function for those taking warfarin.
People who may not have known about the sometimes fatal consequences of hemorrhaging while taking this blood thinner may want to consult with Pradaxa lawsuit attorneys and find out whether or not to pursue a legal remedy. Get a free legal review with one at the Pradaxa Internal Bleeding Class Action Lawsuit Investigation by filling out the short form there and learn whether or not a claim can be filed against the drug maker.
Updated May 22nd, 2013
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