FDA Advisory Panel Recommends Approval of New Anti-Clotting Drug Linked to Increased Bleeding Risk

Rivaroxaban, a new drug designed to prevent deadly blood clots from forming following hip or knee replacement surgery, should be approved despite a study suggesting it may increase the risk of severe internal bleeding, an FDA advisory panel says.

The new drug, made by Bayer and Johnson & Johnson, is aimed at preventing deep-vein thrombosis and pulmonary embolism. It is a rival drug to another blood-thinner called warfarin, which is also sold under the brand name Coumadin.

Earlier this week, FDA documents revealed that rivaroxaban could cause an increased risk of major bleeding, which in some cases may require surgery to stop. The documents also raised concerns about liver injury and toxicity from long-term use of the drug, which is currently only being considered for short-term use immediately after hip or knee replacement surgery.

Bleeding Risk Noted, but Outweighed

However, the FDA advisory panel comprised of medical experts, while noting the increased bleeding risk, ruled by a vote of 15-2 that the potential benefits of rivaroxaban outweighed the risks. The panel recommended that the drug be approved by the FDA, which is not required to follow the recommendation of the panel, but in most cases, it does.

Clinical trials of rivaroxaban showed the drug was far more effective at controlling blood clots than other anticoagulants. However, the study also found that nearly twice as many people taking rivaroxaban experienced major bleeding compared to people taking other drugs.

FDA officials who analyzed the data ruled that the risk of major bleeding meant rivaroxaban was not superior to other anti-clotting drugs already on the market. The advisory panel members disagreed with the FDA officials and said rivaroxaban should be given the green light.

Anti-Clotting Drugs are Big Business

Americans spent $304 million in 2008 on the top three prescription thrombosis drugs, but some industry estimates have put the potential for income from drugs in the category could someday reach as high as $6 billion a year if they are approved for treatment of chronic conditions.

Pfizer, Sanofi-Aventis, and other big drug companies also are developing anti-clotting medications.

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