Health Canada Issues Warning Over Rituxan and SJS, TENs

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Ottawa, ON: Hoffmann-La Roche Limited, in consultation with Health Canada, has informed health care professionals of important safety information regarding RITUXAN (rituximab).

Specifically, the agency is warning that severe skin reactions such as Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS) have been reported very rarely in patients who were given RITUXAN for the treatment of cancer or disorders of the immune system such as rheumatoid arthritis (RA). Some cases resulted in death.

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. These may occur on the day of infusion, within a few days, a week, or up to four months following the infusion.

RITUXAN is a medication that is given by intravenous infusion to treat cancer of the lymph cells and bone marrow. RITUXAN may also be used to reduce the signs and symptoms of rheumatoid arthritis (RA) and to reduce inflammation associated with severe Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).

The prescribing information already includes information on these skin reactions for patients who are taking RITUXAN for the treatment of cancer. Based on the new safety information for patients who are taking RITUXAN for the treatment of rheumatoid arthritis (RA), Roche will be working with Health Canada to update the prescribing information accordingly.

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