On Oct. 28, 2005, the U.S. Food and Drug Administration and the manufacturer of Zevalin, Biogen Idec, issued a drug safety alert warning doctors of severe reactions – some fatal – associated with the cancer therapy medication.
They said Zevalin (ibritumomab tiuxetan) therapeutic regimen had been associated with severe skin reactions, some resulting in death.
If you had a loved one who died as a result of using the Zevalin therapeutic regimen, you may want to contact a Zevalin lawyer.
The BOXED WARNING for Zevalin was revised to state the following:
“Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some with fatal outcome, have been reported in association with the ZEVALIN therapeutic regimen. Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further component of the Zevalin therapeutic regimen and should seek prompt medical evaluation.”
A warning in the Zevalin package insert also notes that “deaths have occurred within 24 hours” of rituximab infusion, an essential component of the Zevalin therapeutic regimen, according to MedPage Today, a widely used medical news service for physicians.
The ZEVALIN therapeutic regimen, administered over seven to nine days, is a cancer therapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin’s lymphoma (NHL). Earlier, in September, Biogen Idec had also changed Zevalin’s labeling to include a “black box” warning about reports of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, and exfoliative dermatitis in patients who took the therapeutic regimen. Some of those cases resulted in death.
Kline & Specter PC, a Philadelphia-based law firm with more than 30 attorneys, several of whom are also highly skilled doctors, has had success litigating product liability and prescription drug lawsuits in the Pennsylvania-New Jersey region and nationwide. For an evaluation of your case, contact a Zevalin attorney.
