A drug used to treat breast or colorectal cancer that has spread is associated with very rare cases of severe skin reactions, Health Canada says.

"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.

The regulator said it endorsed the safety information from Hoffmann-La Roche.


Roche said it will work with Health Canada to update the prescribing information for Xeloda to include the risk of severe skin reactions. (Steffen Schmidt/Keystone/Associated Press)

Xeloda (capecitabine) is approved to treat advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), 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.
  • Fever.
  • 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.

Patients who develop any of these symptoms should contact their health-care professional immediately.

The company said it will work with Health Canada to update the prescribing information.