Yourlawyer.com (Zevalin News) http://www.yourlawyer.com/topics/overview/Zevalin Fri, 19 Sep 2014 16:00:01 -0400 Fri, 19 Sep 2014 16:00:01 -0400 pixel-app en FDA and Biogen Idec Issue Drug Safety Alert Concerning Fatal Reactions to Cancer Drug, Zevalin http://www.yourlawyer.com/articles/title/fda-and-biogen-idec-issue-drug-safety-alert-concerning-fatal-reactions-to-cancer-drug-zevalin Sun, 30 Oct 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/title/fda-and-biogen-idec-issue-drug-safety-alert-concerning-fatal-reactions-to-cancer-drug-zevalin
http://www.fda.gov/medwatch/safety/2005/safety05.htm#Zevalin

The alert and warning revision (http://www.fda.gov/medwatch/safety/2005/ZevalinPI.pdf) describe severe cutaneous or mucocutaneous reactions, some with fatal outcome, that have been reported in association with the Zevalin therapeutic regimen in the post-marketing experience.

Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the Zevalin therapeutic regimen and should seek prompt medical evaluation.

Similar events have been associated with Rituxan (rituximab), a component of the Zevalin therapeutic regimen according to the senior director of drug safety and risk management for Biogen Idec, in its advisory letter.

http://www.fda.gov/medwatch/safety/2005/Zevalin_dearhcp.pdf

The Zevalin “regimen” combines the anti-CD20 monoclonal antibodies Zevalin (ibritumomab tiuxetan) and Rituxan with indium-111- and yttrium-90 labeled radioisotopes. The regimen is indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma (NHL), including patients with follicular B-cell NHL that is refractory to Rituxan.
 
"Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen," reads a boxed warning in the Zevalin package insert. "These fatalities were associated with an infusion reaction symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Approximately 80% of fatal infusion reactions occurred in association with the first rituximab infusion."

In September Biogen Idec changed the Zevalin product labeling to include a black-box warning about post-marketing reports of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, and exfoliative dermatitis in patients who received the Zevalin therapeutic regimen. Some of the cases resulted in death.

Onset of the reactions was variable; in some cases occurring within only days of administration, while in other cases the reactions occurred at three to four months.

Serious adverse events associated with the use of Zevalin should be reported to Biogen Idec at 1-877-866-4332 or to the FDA's MedWatch reporting system (1-800-FDA-1088). 
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Zevalin Side Effects Lawsuits | Side Effects: Fatal Skin Reaction, Erythema Multiforme, Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) http://www.yourlawyer.com/topics/overview/Zevalin Sun, 30 Oct 2005 00:00:00 -0400 http://www.yourlawyer.com/topics/overview/Zevalin CLICK HERE TO DOWNLOAD OUR ZEVALIN INFORMATION PACKAGE

Zevalon Side Effects May Lead To Skin Disease Lawsuits

Zevalin | Lawsuits, Lawyers | Side Effects: Fatal Skin Reaction, Erythema Multiforme, Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN)

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.

Legal Help For Victims Affected By Zevalin

If you or a loved one took Zevalin and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney or call us anytime at 1-800-YOURLAWYER (1-800-968-7529).

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