Posted By Jim Vititoe on April 8, 2009
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FOR IMMEDIATE RELEASE
Statement
April 8, 2009
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Media Inquiries:
Rita Chappelle, 301-796-4672
Consumer Inquiries:
888-INFO-FDA
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Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.
Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.
The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva’s labeling regarding PML.
Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.
Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.
More information about the withdrawal of Raptiva is available on the Genentech Web site: www.gene.com/gene/products. Prescribers with questions about Raptiva may contact Genentech Medical Communications at (800) 821-8590.
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If you have been seriously injured by the above event, please visit the products liability lawyers at Masry & Vititoe for a case evaluation. Through experience and education, Masry and Vititoe is able to expertly evaluate medical injuries and pursue personal injury claims on behalf of the injured plaintiff.
Categories: FDA, Medical Recall, Medical Warning
Tags: raptiva
About the author
Jim was born in Oklahoma City, Oklahoma on March 14, 1947. His father was in the military and his family moved to Germany when Jim was 5. In 1956, his family relocated back to the United States and lived in Georgia. In 1965, Jim graduated from Northside High School in Warner Robins, Georgia, where he was President of the Student Body, Honorary Mayor of the Town and selected as Most Versatile Student.
Jim attended the College of William & Mary in Williamsburg, Virginia and graduated with a degree in psychology in 1971. He moved to Hawaii to work for United Airlines and to enjoy his passion for worldwide travel. He also managed to attend the University of Hawaii for a few extra enrichment classes.
In 1973, Jim moved to Los Angeles to attend Southwestern University School of Law. He was on the Dean's List, President of the Student Bar Association, and was the recipient of the prestigious Frederick Graff Award for most outstanding student.
After graduation from Law School, Jim became an associate in the Law Offices of Edward L. Masry. Jim worked for several years as an associate attorney and in 1982 Jim became a partner. The Law Offices of Edward L. Masry was renamed The Law Offices of Masry & Vititoe. Jim married Karen Dutcher in 1984 and they have two children, Justin and Travis.
Over the past 20 plus years, Jim has specialized in civil tort litigation. He has handled thousands of wrongful death cases, work-related injuries, and personal injuries. Typical cases have included auto collisions, product liability, premises liability, medical malpractice, and environmental exposure. Recently, his focus and specialty has been brain injury cases including severe and mild traumatic brain injuries [MTBI].
Jim has received much recognition over his career. He has received the U.S. Congressional Award for Trial Lawyer of the Year in 1990, 1991 and 1992. Consumer Attorneys of California awarded him Trench Soldier of the Year in 1996; Presidential Recognition for Exceptional Contribution in 1996; Outstanding Consumer Advocate in 1997; and the President's Award of Merit in 2000. Trial Lawyers for Public Justice (TLPJ) awarded Jim the President's Award in July 2001 in recognition of his extraordinary work and success in building membership support.
Jim was appointed to the Board of Governors for the Consumer Attorney Association of Los Angeles in 1998. He was appointed to the Board of Governors for the American Trial Lawyers Association, Trial Lawyers for Public Justice, and Consumers Attorneys of California in 2001.
Jim was born in Oklahoma City, Oklahoma on March 14, 1947. His father was in the military and his family moved to Germany when Jim was 5. In 1956, his family relocated back to the United States and lived in Georgia. In 1965, Jim graduated from Northside High School in Warner Robins, Georgia, where he was President of the Student Body, Honorary Mayor of the Town and selected as Most Versatile Student.
Jim attended the College of William & Mary in Williamsburg, Virginia and graduated with a degree in psychology in 1971. He moved to Hawaii to work for United Airlines and to enjoy his passion for worldwide travel. He also managed to attend the University of Hawaii for a few extra enrichment classes.
In 1973, Jim moved to Los Angeles to attend Southwestern University School of Law. He was on the Dean's List, President of the Student Bar Association, and was the recipient of the prestigious Frederick Graff Award for most outstanding student.
After graduation from Law School, Jim became an associate in the Law Offices of Edward L. Masry. Jim worked for several years as an associate attorney and in 1982 Jim became a partner. The Law Offices of Edward L. Masry was renamed The Law Offices of Masry & Vititoe. Jim married Karen Dutcher in 1984 and they have two children, Justin and Travis.
Over the past 20 plus years, Jim has specialized in civil tort litigation. He has handled thousands of wrongful death cases, work-related injuries, and personal injuries. Typical cases have included auto collisions, product liability, premises liability, medical malpractice, and environmental exposure. Recently, his focus and specialty has been brain injury cases including severe and mild traumatic brain injuries [MTBI].
Jim has received much recognition over his career. He has received the U.S. Congressional Award for Trial Lawyer of the Year in 1990, 1991 and 1992. Consumer Attorneys of California awarded him Trench Soldier of the Year in 1996; Presidential Recognition for Exceptional Contribution in 1996; Outstanding Consumer Advocate in 1997; and the President's Award of Merit in 2000. Trial Lawyers for Public Justice (TLPJ) awarded Jim the President's Award in July 2001 in recognition of his extraordinary work and success in building membership support.
Jim was appointed to the Board of Governors for the Consumer Attorney Association of Los Angeles in 1998. He was appointed to the Board of Governors for the American Trial Lawyers Association, Trial Lawyers for Public Justice, and Consumers Attorneys of California in 2001.
Jim is currently a member of the American Trial Lawyers Association, American Bar Association, Trial Lawyers for Public Justice, Consumer Attorneys of California, Consumer Attorneys Association of Los Angeles, and the Los Angeles County Bar Association.
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