A notice about the risk of severe skin reactions associated with the cancer drug capecitabine – including Stevens-Johnson syndrome – has been released by the Canadian health department.
"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" capecitabine, according to a letter to health care professionals, posted on the Health Canada website on Dec. 3. The letter states that treatment with capecitabine should be "immediately discontinued" if a patient develops signs and symptoms of SJS or TEN.
No such notice has been posted by the U.S. Food and Drug Administration. The FDA "constantly monitors and reviews reports from regulatory agencies, especially those concerning products that affect Americans’ health," and is reviewing related scientific information on this issue, an FDA spokesperson said in response to a query on the notice. The agency "will determine what, if any, actions to take," he added.
Capecitabine is a nucleoside metabolic inhibitor, and is marketed as Xeloda in Canada and the United States for treatment of colorectal cancer and breast cancer. In the United States, it was initially approved in 1998 for treating metastatic breast cancer, and is now also approved as a first-line treatment for metastatic colon cancer, as well as for adjuvant colon cancer in patients with Dukes’ C colon cancer. It is marketed by Roche, which the letter says is working with Health Canada to revise the product monograph in Canada. In the United States, a generic formulation is also available.
The U.S. label includes hand-and-foot syndrome (including grade 2 and 3 events), dermatitis, rash, and erythema among the skin and subcutaneous adverse events reported in clinical trials, but there are no reports of SJS or TEN listed.
Serious adverse events associated with capecitabine should be reported to MedWatch, the FDA Safety Information and Adverse Event Reporting Program, at www.fda.gov/Safety/MedWatch/default.htm.