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Pradaxa Under the FDA’s Watchful Eye

Pradaxa is a blood-thinner that is prescribed to many patients in Atlanta to lessen the chance of stroke and blood clots in people with atrial fibrillation (AFib) not caused by heart valve trouble. It has only been available to patients for two years; however, the side effects associated with the use of Pradaxa have already caught the attention of the U.S. Food and Drug Administration (“FDA”).

The latest studies suggest that Pradaxa use poses an increased risk to the heart. Though the blood-thinner is used in the treatment of atrial fibrillation patients to protect them against the possibility of stroke, the newest fear is that dabigatran can cause a Pradaxa Heart Attack. Seven studies have found a 33 percent increase in Pradaxa heart attacks or chest pain (angina) compared to patients using another drug, like warfarin, or a placebo.

Though the chance of a Pradaxa heart episode is small at 1.19 percent in contrast to .79 percent, even so it is a risk. Interestingly, the data used from the seven studies was gathered from clinical testing that encouraged the FDA to approve Pradaxa two years ago. The results of the meta-analysis have been published in the Archives of Internal Medicine.

It is not known why Pradaxa patients have a greater chance of heart events than patients who use warfarin (coumadin). Though one doctor suggests that warfarin (coumadin) may have certain heart benefits that dabigatran doesn’t. However, Pradaxa bleeding isn’t as common as the possible bleeding that is linked with warfarin use. Therefore, the FDA was all too happy to approve Pradaxa because it was the first noteworthy substitute for warfarin (coumadin) in 50 years.

Attorney Robert J. Fleming has been handling wrongful death cases, automobile accident cases, personal injury cases, dental malpractice and medical malpractice lawsuits for individuals and families who have been harmed, injured or died as a result of the carelessness or negligence of another for more than 20 years in and around Atlanta, Georgia and its surrounding areas, including Alpharetta, Austell, Avondale Estates, Chamblee, College Park, Conyers, Duluth, Decatur, Doraville, Hapeville, Johns Creek, Jonesboro, Lawrenceville, Norcross, Peachtree City, Riverdale, Roswell, Sandy Springs, Stone Mountain, and Smyrna. If you have been seriously injured and would like quality legal representation, contact Robert J. Fleming directly on (404) 525-5150 or contact us online.