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FDA Reviewing Lower-Dose Option of Xarelto

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The U.S. Food and Drug Administration is currently reviewing a new low-dose version of the blood thinner Xarelto intended to “broaden the physician’s ability to customize treatment plans based on the needs of the patient,” according to Johnson & Johnson, parent company of Janssen Research & Development LLC.

The new 10 mg dose was designed specifically for patients with venous thromboembolism (VTE), a condition that heightens the risk of blood clots forming in the veins, where they can lead to deep vein thrombosis or pulmonary embolism. VTE is typically treated with anticoagulants over an extended period of time to keep clots from continuing to form.

Lower Dose Based on Study

According to Janssen, the lower dosage is based on data from the 2017 EINSTEIN CHOICE study, which examined two doses of Xarelto in patients with VTE. The study found that extended treatment with low-dose rivaroxaban was nearly three times more effective in reducing VTE than aspirin with a similar rate of bleeding in patients who had undergone six to 12 months of anticoagulation treatment. A follow-up study is planned to determine whether low-dose rivaroxaban is equally effective in other patient populations.

Since its approval in 2011, Xarelto has been offered in a convenient one-size-fits-all dose of 20 mg. Many have questioned this dosing, however, believing that it might be potentially dangerous. In a 2012 QuarterWatch report, the Institute for Safe Medicine Practices (ISMP) stated that studies concerning Xarelto had demonstrated variations in the time it takes blood to clot that could possibly be eliminated by twice-a-day dosing. Splitting the dose into two pills a day instead of one could potentially even out the effects of the anticoagulant and lower the patient’s risk of uncontrollable bleeding.

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