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FDA panel to discuss approval of drug which raises safety concerns

March 19, 2009 by  

FDA panel to discuss approval of drug which raises safety concernsDespite serious doubts about its safety, rivaroxaban is still being considered for approval by the FDA.

Rivaroxaban, a once-a-day pill for the prevention of blood clots in hip or knee replacement surgery patients, is also marketed as Xarelto by Bayer AG and Johnson & Johnson.

However, an FDA review has found evidence that the drug causes excessive bleeding and other cardiovascular events at a rate that is twice as high as the existing alternatives, according to a Reuters report.

In addition to the bleeding problem, the agency has also found evidence of an increase in a liver enzyme that may be indicative of liver damage.

The reviewers noted that studies were under way that should provide information regarding liver safety.

Reuters says that the studies are funded by the two drug companies.

FDA’s approval board is expected to make a decision today, after hearing from a panel of outside experts.

The shares of Bayer and Johnson & Johnson’s fell by 10 and 1 percent, respectively, when the documents were released on Tuesday.
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