FDA panel recommends agency approval of heparin alternative

March 23rd, 2009 by Jennifer Walker-Journey

blood cells 100x100A Food and Drug Administration () advisory panel voted last week to recommend agency approval of experimental rivaroxaban, according to Forbes. The medication, made by Johnson & Johnson and Bayer Healthcare Pharmaceuticals, is designed to be used on a short-term basis to prevent pulmonary embolism and deep-vein thrombosis in patients having total knee or hip replacement surgery. Blood clots are common after such surgeries.

Rivaroxaban, a pill marketed in Europe as Xarelto, showed to be more effective than the anticoagulant heparin, while presenting no more side effects than heparin. Side effects of and rivaroxaban include the risk of internal bleeding. Another benefit of rivaroxaban is that it does not need constant monitoring like another popular , warfarin. is administered intravenously while warfarin is a pill taken orally.

Pharmaceutical companies have long been working on safer and easier alternatives to and warfarin, especially since the tainted scandal last year where more than 80 Americans died and hundreds more were made sick after receiving injections of batches of that had been laced with oversulfated chondroitin sulfate (OSCS), a contaminant that mimics but can cause serious allergic reactions in humans.

The is expected to make a decision whether to approve rivaroxaban by May 28. If approved, rivaroxaban would be the first oral approved since the approved warfarin in 1954, according to Forbes.

“We appreciate the thoroughness of the advisory committee’s review, and we will continue to work with the as they finalize their review,” Dr. Peter DiBattiste, vice president of Johnson & Johnson Pharmaceutical Research and Development, said in a prepared statement.

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