Pradaxa was first released into the market in 2010 by German pharmaceutical giant Boehringer-Ingelheim. The drug immediately reached blockbuster status by notching over $1 billion dollars in sales. In its initial stages, Pradaxa was thought to be a next generation drug that would replace the most common drug used to prevent strokes and blood clots, Coumadin, better known as Warfarin.
Coumadin is a blood thinner that has been the primary drug of choice for nearly 60 years to treat atrial fibrillation, or irregular heart rate, and prevent strokes that are associated with atrial fibrillation. One of the disadvantages of Coumadin is that it requires patients to undergo continual blood tests so that dosage adjustments can be made, if necessary.
The optimum dosage will serve to prevent strokes by thinning the blood but not thinning it so much as to cause a bleed. If the dosage is too high and a bleed results, Vitamin K and fresh frozen blood plasma can be given to the patient to reverse the effects and slow the bleeding.
Pradaxa was supposed to be more effective than Coumadin, safer and easier for patients to use. It would also not require the continual blood work regime. Unfortunately, that proved not to be the case. Pradaxa turned out to be a more dangerous substitute for Coumadin.
If a bleed occurs while using Pradaxa, there is no reversal. Simply put, traumatic bleeding cannot be stopped. Often it is even impossible to perform life-saving surgery because excessive bleeding during the procedure might prove to be worse than the initial trauma. Tthe widespread use of Pradaxa is filled with high risk for the patients who use it.
Initially the health risks of using Pradaxa were not provided to the public, specifically that traumatic bleeding cannot be stopped since there is no available reversal agent. This was documented in an issue of the Journal of Neurosurgery in March of 2012, which concluded that once the internal bleeding begins there is not much that can be done to stop it.
The FDA launched an investigation regarding the safety of Pradaxa in December 2011. There was no recall of the drug mandated. However, in September 2012, the Journal for the American Medical Association initiated new demands for a Pradaxa recall, due to the fact that perhaps the FDA overlooked the side effects of internal bleeding as it rushed to approve the drug.
Unfortunately the many patients taking Pradaxa for their atrial fibrillation are exposed to this danger of internal bleeding. The safety of Pradaxa was called into question shortly after usage began in the U.S. Some 542 deaths and 3,781 side effect problems were linked to the drug in 2011.
If you or a family member has suffered from internal bleeding, had a heart attack or lost a loved one after taking Pradaxa, you need to talk to a San Antonio personal injury lawyer who is experienced in handling dangerous and defective drug cases.
Carabin & Shaw is a San Antonio based firm with offices throughout the state. We have the resources and experience to fight the giant pharmaceutical companies so that you will maximize your recovery.
Please contact us through our website or call us direct in San Antonio at (210) 222-2288 for a no obligation consultation. For other calls, please call us toll free at (800) 862-1260.
A Promising Drug With a Flaw, The New York Times, Article by Katie Thomas, November 2, 2012
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