Treanda Stevens-Johnson Syndrome Cases Lead to New Warnings

According to Cephalon, Inc., at least two users of their cancer drug Treanda developed a severe form of the skin condition Stevens-Johnson syndrome, known as toxic epidermal necrolysis, and at least one has died. As a result, the drug’s warning label will be updated about the risk of using the drug in combination with allopurinol.

Treanda (bendamustine HCl) is an intravenous injection approved by the FDA last year for treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. It is manufactured by Cephalon and provides a reduced treatment time, as the infusion takes about an hour and can be done on an outpatient basis.

In a recent filing with the U.S. Securities and Exchange Commission, Cephalon disclosed that they have become aware of two Treanda Stevens-Johnson syndrome (SJS) cases which had progressed to the level of toxic epidermal necrolysis (TEN). One of the two patients died as a result of the condition in December 2008.

Stevens Johnson syndrome is a rare and potentially fatal skin reaction that can be caused by several medications. It affects the skin and mucous membrane, causing severe burns and rashes over large portions of the body.

When more than 30% of the body is covered with skin lesions, the condition is known as Toxic Epidermal Necrolysis Syndrome or Lyell’s Syndrome. About 5% too 15% of severe Stevens-Johnson syndrome cases result in death, and non-fatal cases can result in organ damage and blindness.

Both of the Treanda Toxic Epidermal Necrolysis cases involved chemotherapy patients who were taking the drug together with allopurinol, which has also been associated with Stevens-Johnson syndrome side effects.

The SEC filing indicates that the FDA has approved an update to the prescribing information about the potential Stevens-Johnson Syndrome risk, and the revised label should be finalized early next month.

In September 2008, similar Stevens-Johnson syndrome warnings were placed on the cancer drug Revlimid (lenalidomide), which is a competing treatment that was impacted by the introduction of Treanda. The warnings about Revlimid SJS side effects were added after 14 post-marketing reports of the adverse skin reaction were associated with use of the drug, resulting in at least two deaths.