Caution with Xeloda taken with Coumadin

The U.S. Food and Drug Administration has issued a new warning about potentially serious side effects when the cancer drug Xeloda (capecitabine) is taken simultaneously with the blood thinner Coumadin (warfarin).

The FDA warning, which will beef up its existing labeling requirement for Xeloda's package insert, is only the latest example of potential interactions that can result when different drugs and other products (such as herbs and supplements) are taken simultaneously. It also underscores the importance of telling your doctor about all of the products you are taking.

Xeloda, manufactured by Hoffman-La Roche, is an oral cancer therapy that was initially approved for breast cancer in April, 1998. In September, 2001 the FDA approved the use of Xeloda in combination with Taxotere (docetaxel) for treating patients with metastatic breast cancer whose cancer has progressed after treatment with an anthracycline-containing cancer therapy (such as Adriamycin and doxorubicin).

Coumadin, manufactured by Dupont Pharmaceuticals, is an anticoagulant. These drugs decrease the clotting ability of the blood and therefore help to prevent harmful clots from forming in the blood vessels. (They are sometimes called blood thinners, although they do not actually thin the blood.)

The new FDA warning strengthens its earlier labeling requirement that Xeloda can have significant drug interaction with oral coumarin-derivative anticoagulant therapy (e.g., Coumadin), which can result in serious bleeding complications.

The new warning says, "Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly."

SOURCE:
U.S Food and Drug Administration (www.fda.gov)

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