Xeloda Black Box Warning Added Due toBleeding Risk with Blood Thinner Use

The new Xeloda warnings are part of a program reviewing cancer drugs which have been on the market for decades and may need label warning updates.

Federal drug regulators have placed a “black box” warning on Xeloda, indicating that the cancer drug may increase the bleeding risk when taken with a class of blood thinners known as vitamin K antagonists, like warfarin.

The new Xeloda label warning (PDF) was announced on January 17, in the Journal of the American Medical Association (JAMA).

The update comes as a result of an U.S. Food and Drug Administration (FDA) pilot program known as Project Renewal, which has the agency taking a look at cancer drugs that are several decades old, and may need their labels updated due to out-of-date formatting or have significant off-label uses.

Xeloda (capecitabine) is approved for the treatment of colorectal cancer and breast cancer. In the United States, the Roche medication was first approved by the FDA in 1998, and it is now also available as a generic. In 2013, the cancer drug was linked to a risk of  Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Some cases of the Xeloda skin reactions have resulted in death, Health Canada researchers warned.

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As a result of the recent investigation, the FDA added a new boxed warning, which is the most stringent warning the agency can require a drug to carry, indicating using Xeloda with a vitamin k antagonist blood thinner could increase the risk of bleeding.

“Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with oral vitamin K antagonists,” the new boxed warning states.

The new label warnings also include new and revised indications for colon, rectum, breast, gastrointestinal tract and pancreatic cancers. It also includes changes on dosing regimens.


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