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 same disease.

Internal bleeding is a common side effect with most blood thinners, and often patients who use the medications have to be monitored. Researchers have been working on treatments that could fight blood clots yet not carry the same risk for bleeding events.

Last year, the FDA approved Boehringer Ingelheim’s Pradaxa (dabigatran), which, like Xarelto, is indicated for stroke prevention patients with a certain type of irregular heartbeat. However, the medication has not shown to be as safe as expected.

Since Pradaxa has been on the market, at least 505 bleeding events involving Pradaxa have been reported to the FDA MedWatch Adverse Event Reporting Program. In the first quarter of 2011, more instances of Pradaxa hemorrhages were reported to the FDA than any other drug. What makes Pradaxa more dangerous that other blood thinner that there is no antidote for Pradaxa. Once bleeding occurs, it is almost impossible to stop.

Pradaxa is not yet approved for the treatment of lung and leg clots. The drug was tested in leg and lung clot patients in clinical trials but the results have not yet been submitted for regulatory approval.

Source: Bloomberg

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