Pradaxa by the numbers371,000 » The number of patients who received Pradaxa prescriptions from pharmacies between October 2010 and August 2011, according to the FDA. 18,000 » The number of volunteers in a clinical study that showed major bleeding events in patients using Pradaxa or warfarin occurred at similar rates. 11,440 » The number of Utahns who filled 41,292 prescriptions for warfarin in 2010, according to data from the state’s All Payer Database, a repository of commercial insurance claims. He declined quickly, lapsing into a deep coma within six hours. Repeat scans showed blood had nearly filled the left side of the brain and a good portion of the right. He died soon after, prompting Garber and her colleagues to publish a case report alerting physicians and patients to the risk of uncontrollable bleeding with a new type of blood thinning medication, called direct thrombin inhibitors. The study, published Tuesday in the Journal of Neurosurgery, adds to a growing chorus of concern about the drug at a time when similar medications are poised for approval by the U.S. Food and Drug Administration [FDA]. Approved in October 2010, dabigatran etexilate, or Pradaxa, has been shown in clinical trials to do a better job than other blood thinners at reducing the risk of stroke in some patients, say the authors. It’s easier for doctors to administer than the leading blood thinner warfarin, which can interact with food and other medicines, requiring monthly blood testing to tailor the dose. But once bleeding starts, it’s largely irreversible, because there’s “no known agent” to counteract Pradaxa’s effects, said Garber, a neurosurgery resident. Pradaxa is prescribed to prevent strokes and blood clots in people with atrial fibrillation, or an irregular heart beat. But the drug works differently than warfarin, which is easily blocked with an injection of vitamin K. The only recognized treatment for a Pradaxa induced bleed is dialysis, which take hours to help patients eliminate the drug through their kidneys, the U. study says. High doses of clotting drugs have been shown to help in mice. The 83-year-old Salt Lake City man had an irregular heart beat. In addition to Pradaxa, he was taking medications to control his cholesterol and gastric reflux. Pradaxa lawyers and the helpline are fighting for Victims of Pradaxa and Xarelto and their families. Call the Pradaxa Helpline and speak to a Geriatric medical social worker and a Pradaxa lawyer today.
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