Biogen Idec warned on October 28, 2005 that one of its drugs to treat non-Hodgkin’s lymphoma, Zevalin (generic: ibritumomab tiuxetan), can cause severe and sometimes fatal skin reactions and death. A warning has been added to Zevalin’s label and a letter was sent to prescribing physicians. The alert and warning revision describes severe cutaneous or mucocutaneous reactions, some with fatal outcomes, that have been reported in association with the Zevalin therapeutic regimen in the post-marketing experience. Zevalin’s product label was changed to include a black-box warning about reports of erythema multiforme, Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), bullous dermatitis, and exfoliative dermatitis in patients who received the Zevalin therapeutic regimen. Some of the cases resulted in death.
Because potentially fatal side effects have been connected with Zevalin during clinical trials, the drug is approved only for patients who have not responded to other treatments, according to an FDA paper. A Biogen Idec representative said the warnings being added to the Zevalin label are already on the Rituxan label. Zevalin is occasionally used on patients who don’t respond to Biogen Idec’s other lymphoma drug, Rituxan. Zevalin was developed by Idec Pharmaceuticals, who has since merged with Biogen, forming Biogen Idec.
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