Capecitabine Associated with Stevens-Johnson syndrome and TEN

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Ottawa, ON: Xeloda (capecitabine) a drug used to treat breast and metastatic colorectal cancer, is associated with severe skin reactions, such as Stevens Johnson Syndrome (SJS) Health Canada said in a statement.

"Very rare cases of severe cutaneous reactions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), in some cases with fatal outcome, have been reported during treatment with Xeloda," Health Canada said in a letter to health professionals on Tuesday.

Xeloda (capecitabine) is approved to treat advanced breast cancer or metastatic breast cancer, metastatic colon or rectum cancer and cancer of the colon following complete surgical removal, Health Canada said.

Signs and symptoms of severe skin reactions may include:

Flu-like symptoms.


Itching of the skin.

Painful, red or purplish skin rash that spreads and blisters causing the top of the skin to shed.

Mouth sores.

Eye burning, itching and discharge.

Hoffman LaRoche, the maker of capecitabine, said it will work with Health Canada to update the prescribing information.

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