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Xarelto 217 articles

Doctors question safety of new blood thinners Pradaxa, Xarelto

When the Food and Drug Administration (FDA) recently approved two new blood thinners to prevent strokes in some cardiac patients, the medical community was hopeful that the medications would serve as a safer alternative to warfarin, a blood thinner that has been on the market for nearly 60 years. Patients on warfarin need to be monitored on a regular basis because the drug increases the risk for internal bleeding. But growing complaints of bleeding events, some of them fatal, have made some cardiologists leery of prescribing the new blood thinners. The two new drugs include Pradaxa, made by Boehringer Ingelheim, ... Read More

FDA panel rejects expanding indication for blood thinner Xalerto

A Food and Drug Administration (FDA) advisory panel has rejected a bid from drug makers Bayer and Johnson & Johnson to widen the indication for the blood thinner Xarelto to prevent strokes in patients with acute coronary syndrome. The drug’s bleeding risk was at issue, but the most pressing concern was confusion surrounding data provided by the drug’s makers. The panel voted 4-6-1, with one panel member abstaining, against approving the drug. Xalerto’s application will move on to the FDA, which will decide whether the drug should be approved. The FDA does not always follow the recommendations of its advisory ... Read More

FDA considers more uses for blood thinner despite bleeding risk

A Food and Drug Administration (FDA) advisory panel will consider widening the indication for Johnson & Johnson’s blood thinner Xarelto, but regulators are already questioning the drug’s risk for internal bleeding. Xarelto was approved last year for to prevent strokes in patients with a heart rhythm abnormality called atrial fibrillation, and for short-term use in preventing blood clots in patients undergoing knee or hip replacement surgery. The FDA advisory panel will consider whether to allow the drug to be used to treat acute coronary syndrome, a condition that occurs when a blood clot develops inside a coronary artery and reduces ... Read More

New study to analyze Pradaxa patients around the world

Boehringer Ingelheim Pharmaceuticals has launched a new clinical analysis called the GLORIA-AF Registry Program, which, the company says, is the “largest prospective observational study in non-valvular atrial fibrillation (NVAF) currently planned. Part of the study will be devoted to studying the safety and efficacy of Pradaxa 150mg capsules across diverse clinical settings and patients groups. GLORIA-AF will follow 56,000 patients being treated in 2,200 registered sites in 50 countries. Patients enrolled in the study will be newly diagnosed with NVAF and at risk of stroke. The condition is characterized by an irregular heartbeat that can cause blood clots to form ... Read More

New blood thinner may be safer than Pradaxa

Xarelto, a new blood thinner by Johnson & Johnson, has been found to reduce the recurrence of blood clots in the lungs with half the risk of severe bleeding caused by other medications. Xarelto was approved by the Food and Drug Administration (FDA) last year for the prevention of strokes in patients with irregular heart rhythms. Johnson & Johnson is hoping to expand its indication to include the treatment of lung and leg clots. Blood clots typically start in the legs and can travel to the lungs, thus the treatment is aimed at two problems, which are manifestations of the ... Read More

Surgeons hopeful about new alternatives to heparin

Surgeons are anticipating the approval of new blood thinners that could replace more conventional methods currently in use, according to the Ortho SuperSite, a resource for orthopedic surgeons and rheumatologists. “As orthopedic surgeons, we look very critically at safety; we look very critically at efficacy. I think it is fair to say, if we consider those to be equal and the dosing schedule is equal, (and) they are both once-a-day, then it comes down to cost,” Richard J. Friedman, M.D., was quoted in the publication. “But we are looking (at) safety first and efficacy afterward.” The topic, spurred by positive ... Read More

FDA panel recommends agency approval of heparin alternative

A Food and Drug Administration (FDA) advisory panel voted last week to recommend agency approval of experimental blood thinner rivaroxaban, according to Forbes. The medication, made by Johnson & Johnson and Bayer Healthcare Pharmaceuticals, is designed to be used on a short-term basis to prevent pulmonary embolism and deep-vein thrombosis in patients having total knee or hip replacement surgery. Blood clots are common after such surgeries. Rivaroxaban, a pill marketed in Europe as Xarelto, showed to be more effective than the anticoagulant heparin, while presenting no more side effects than heparin. Side effects of heparin and rivaroxaban include the risk ... Read More