Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), and Erythema Multiforme (EM)
In late October 2005 Biogen Idec Inc. and the FDA warned doctors about severe and sometimes fatal skin reactions that have been reported in some patients treated with Biogen's lymphoma drug Zevalin.
According to an October 2005 "Dear Doctor" letter from Biogen, the severe skin reactions toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and erythema multiforme (EM) were reported in patients treated with the approved Zevalin regimen, which includes Rituxan, a drug sold by Biogen Idec and Genentech. The Dear Doctor letter also states that similar skin reactions had been reported previously in patients using Rituxan.
The FDA said the Zevalin package insert, or label, as initially approved in 2002 carried a "black box" warning about fatal infusion reactions. This Zevalin black box warning was updated in October 2005 to discuss the severe skin reactions toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and erythema multiforme (EM).
"The potential risk of these reactions should be considered when using the Zevalin therapeutic regimen," Biogen said in its Dear Doctor letter. Likewise, the FDA cautioned that doctors should not continue to give Zevalin to any patient who develops symptoms of a skin reaction.
(Posted by: Tom Lamb)