There is another drug being proposed to the U.S. Food and Drug Administration which is currently under review. Staff at the FDA have expressed concern over bleeding and other risks with Bayer AG’s and Johnson & Johnson’s blood-thinning drug Xarelto. The documents were released ahead of an FDA advisory panel meeting last month where the once-a-day pill for short-term use to prevent blood clots after hip or knee replacement surgery was discussed. If approved, the drug would compete against enoxaparin, the widely-used blood thinner sold as an injectable drug by Sanofi-Aventis SA under the name Lovenox. The rate for bleeding with Xarelto, also known as rivaroxaban, was about twice that of enoxaparin, although the overall rate of bleeding risk was low, according to the FDA report. The staff wrote in one review:
The evidence that administration of rivaroxaban (Xarelto) could lead to bleeding events in significantly more patients relative to enoxaparin amplifies this safety concern for rivaroxaban.
FDA reviewers are saying that long-term safety data are needed to fully weigh the potential for liver damage with the drug. They noted that several company-funded studies were under way that should provide that information. Despite the risks, FDA staff said the company’s data showed the drug was effective in preventing dangerous blood clots in patients undergoing such surgeries. Johnson & Johnson contends that the benefits of Xarelto outweighed its risks and says it would take steps to monitor potential problems after approval. A Bayer spokesman said the company was confident it could address the FDA’s concerns. The FDA is seeking advice from its panel of outside experts before making its decision. The agency usually follows the panel’s recommendations, but not always.
The initial market for Xarelto is somewhat small — the company estimates just 800,000 people receive replacement hips or knees each year in the United States. The greater potential of the drug is said to lie in a future use as a long-term therapy to prevent stroke, which according to the Centers for Disease Control and Prevention affects more than 5 million Americans and is the third-leading cause of death. Bayer and J&J have said they are studying that use as well as the possible prevention of acute coronary syndrome.
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