The United States Food and Drug Administration (FDA) found new information on the relation between serious bleeding and blood thinners such as Pradaxa (dabigatran). An assessment was done using insurance claims and data from its Mini-Sentinel pilot of the Sentinel Initiative to found out information about Pradaxa. The FDA sponsors the Sentinel Initiative. It functions as an active surveillance system that uses healthcare data to assess safety of approved drugs.
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The risks of Pradaxa
According to the results of this assessment, the bleeding rates associated with the use of Pradaxa were not higher than those linked with the use of warfarin, which was consistent with the observations from a clinical trial that was used in approving Pradaxa. With the results of this assessment, the FDA still did not change its recommendations regarding the use of the anticoagulant. FDA maintains that Pradaxa should be carefully prescribed to patients. For patients with renal problems, physicians must still take extra caution and follow dosing recommendations to reduce bleeding. Patients of Pradaxa are caught between tough choices because stopping the use of the drug may also increase the risk of stroke.
Pradaxa could be dangerous
The FDA began evaluating the drug when it received post-marketing reports of serious bleeding among patients who were taking Pradaxa. Most blood-thinners cause serious bleeding that may even be fatal. Patients who have non-valvular atrial fibrillation, non-rheumatic heat beats, however, are prescribed with blood thinners to reduce the risk of clotting and stroke. Although blood-thinners are required for patients with atrial fibrillation, Pradaxa is a dangerous drug to be on and there are lawsuits being filed alleging that its manufacturer did not provide the patients with adequate warnings.
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Warning labels
Manufacturers are duty-bound to disclose all known risks of a drug or medical device. Proper disclosure is important in order to inform doctors and physicians of possible risks to their patients. If manufacturers do not reveal the risks or provide adequate warnings for their patients, they could be liable for the patient’s injuries from taking the drug. If they are found to be negligent, manufacturers could be liable for millions of dollars that the patients’ had to pay in medical expenses, lost wages and pain and suffering incurred while receiving treatment from a severe side effect of the drug.
If you have been injured or have suffered a disability from the use of Pradaxa in Rhode Island or Massachusetts, d’Oliveira & Associates may be able to help you file a claim to get the compensation that you deserve. The firm offers the services of only the most competent and reputable dangerous drugs lawyers in the field of personal injury. You may contact 401-431-1990 or visit our law offices to find out if you have a potential Pradaxa lawsuit.