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FDA recommends J&J’s stroke-prevention drug

The FDA has recommended Xarelto (rivaroxaban) for stroke prevention in patients with the heart condition nonvalvular atrial fibrillation

The Food and Drug Administration (FDA) has recommended Xarelto (rivaroxaban) for stroke prevention in patients with the heart condition nonvalvular atrial fibrillation.

Johnson & Johnson, which partnered with Bayer to develop Xarelto, had previously gained approval for its use in reducing the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee or hip replacement surgery.

The drug received a positive endorsement from the FDA, despite receiving a critical FDA review two days earlier.

A study into Xarelto as a stroke-prevention drug demonstrated that it was as good as other drugs currently being used. However, when switching from Xarelto to another drug, there is a spike of adverse effects, which has not been fully studied yet.

The ease of taking Xarelto (which is administered as one 20mg pill daily) compares favourably to other treatments, as neither International Normalized Ratio (INR) monitoring nor dietary restrictions are necessary.

13th September 2011

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