Xeloda Side Effects Linked to Stevens-Johnson Syndrome: Health Canada

Canadian health officials warn that the cancer treatment drug Xeloda, which is also sold in the United States, has been linked to cases of Stevens-Johnson Syndrome (SJS), a rare and serious skin reaction that can lead to death in some cases.

On December 3, Health Canada issued a letter to health care professionals indicating that side effects of Xeloda have been associated with reports of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Some cases of the Xeloda skin reactions have resulted in death, the Canadian health agency warns.

Stevens-Johnson Syndrome (SJS) is a reaction that is known to be caused by several different medications It involves rashes and burns that on the skin, which develop from the inside out, producing blisters and potentially causing the skin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is typically referred to as Toxic Epidermal Necrolysis (TEN).

Treatment for SJS and TEN usually require inpatient care at a hospital Burn Unit, and it can result in permanent blindness, organ failure and death. Health Canada advises doctors to cease treatment immediately at the first sign of SJS or TEN skin irritation.

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.

The Canadian warning comes just a couple months after the Institute for Safe Medication Practices (ISMP) issued a report indicating that Xeloda was linked to 1,760 deaths in 2012. It was one of three Roche cancer drugs, including Avastin and Tarceva, that were together associated with 15,192 patient deaths.

The ISMP criticized the drug maker for its reports to the FDA, however, noting that most of the adverse event reports submitted to the agency were uninformative, giving scant details as to the reasons for the patient deaths. In the case of Xeloda, the ISMP determined that out f 2,247 total incident reports indicating death or severe injury, 1,466 of them were uninformative.