New labeling for CLL, NHL drug includes TEN warning

The FDA has approved labeling for a drug to treat chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL), to include a warning of a rare but life-threatening reaction to medication known as toxic epidermal necrolysis, also known as TEN, according to MedScape Today. TEN is the most severe form of Stevens Johnson Syndrome, or SJS, a condition that affects the skin and mucus membranes. Rashes appear on the skin and blister over, causing the skin to peel off in sheets. More than 200 drugs are linked to SJS and TEN, the most common being ibuprofen, antibiotics and anti-seizure medicines. The reported incidence of SJS or TEN is about one case per million people per year.

The latest drug to make this list is bendamustine, marketed under the names Teanda in the U.S. and Ribomustin. Bendamustine was first approved by the FDA for treatment of CLL in March 2008 and for NHL in October 2008. It is the first drug approved to treat CLL since 2001.

According to the report, one case of TEN was reported following the use of bendamustine in combination with rituximab, a chimeric monoclonal antibody. TEN has been previously reported for rituxima. Bendamustine’s relationship to TEN has not been fully determined. The label urges healthcare providers: “Where skin reactions occur, they may be progressive and increase in severity with further treatment. If skin reactions are severe or progressive, Treanda should be withheld or discontinued.”