J&J Blood-Clotting Drug May Double Risk of Internal Bleeding, FDA Says

A Johnson & Johnson drug designed to prevent deadly blood clots from forming in people following hip- or knee-replacement surgery may dramatically increase the risk of serious internal bleeding compared to other drugs, the Food and Drug Administration said.

The risks of internal bleeding from the drug, rivaroxaban, are about twice that of another similar drug, called Lovenox and made by Sanofi-Aventis, according to the FDA.

Johnson & Johnson and Bayer, who are partners in the marketing of rivaroxaban, want the once-daily pill approved as an anti-clotting drug to prevent clots from forming in the legs and reaching the lungs or heart, where they can be deadly.

About 800,000 people in the U.S. undergo knew or hip replacements every year, with about half being at risk of blood clots. The FDA is now considering whether to approve rivaroxaban and will seek input this week from an advisory board of cardiologists. The FDA is not required to follow the recommendation of the panel, although it most often does.

However, new FDA documents reveal that studies have shown the drug can result in major bleeding in some patients more frequently than other anti-clotting drugs already on the market.

Studies Find Bleeding, Other Risks

In studies of more than 12,000 patients, major bleeding occurred in 0.4 of patients taking rivaroxaban, compared to just 0.2 of those taking Lovenox, the FDA said. Lovenox is a top-selling drug for Sanofi-Aventis, having earned the company $3.5 billion in sales in 2008.

The FDA also is concerned about the effect of long-term use of rivaroxaban and the potential risks of liver injury and toxicity, which are common side effects of other blood-thinning drugs. Johnson & Johnson and Bayer have said the drug would be used for only two weeks by knee surgery patients and five weeks by hip surgery patients. However, the FDA is worried that the drug may be used longer and will seek input from its advisory panel about information available regarding risks from long-term use of the drug.

More Effective at Reducing Deadly Blood Clots

Studies of knee and hip replacement patients have shown that rivaroxaban lowered the risk of blood clots or death in half, to 0.6 percent, compared with 1.3 percent for patients taking Lovenox.

Rivaroxaban is a member of a new generation of anti-clotting drugs designed to be more effective and safer than older treatments. Patients taking Coumadin, a popular anti-clotting drug also called warfarin, must undergo frequent blood tests because doses of the drug which are too high or too low can lead to strokes or dangerous bleeding.

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