Raptiva

Raptiva (efalizumab) FDA Warning

Since the approval of Raptiva (efalizumab) in October 2003, the FDA has received reports of three confirmed cases and one possible case of progressive multifocal leukoencephalopathy (PML) in patients who were 47 to 73 years of age who were using Raptiva for the treatment of moderate to severe plaque psoriasis. Two of the patients with confirmed PML and one patient with possible PML died. All four patients were treated with Raptiva continuously for more than three years.  None of the patients were receiving other treatments that suppress the immune system while taking Raptiva.

PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system.  When PML occurs, it is usually in people whose immune systems have been severely weakened and often results in an irreversible decline in neurologic function and death. There is no known effective treatment for PML.

Raptiva works by affecting T-cells in the immune system.  The effects of Raptiva also decrease the function of the immune system and increase susceptibility to infections.

Raptiva was approved for the treatment of moderate to severe plaque psoriasis in 2003. There were no cases of PML seen in the clinical trials that supported the approval of Raptiva.  At the time of approval, a total of 2,764 patients had been treated with Raptiva.  Of those 2,764 patients, 2400 had been treated for three months, 904 for six months, and 218 for one year or more.

In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML.  In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva.

The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML.

Healthcare providers should, in the interim, be aware of the following information and advice:

• Raptiva increases the risk of PML.  Longer, continuous use may further increase this risk.
• Inform patients using Raptiva of the potential risk of developing PML.
• There are no known screening tests that can reliably predict PML or medical interventions that can prevent or treat this disease.
• Monitor patients being treated with Raptiva for the onset of neurologic symptoms.  Discontinue Raptiva if PML is suspected.
• Patients treated with Raptiva should be periodically re-evaluated to ensure that the benefit of treatment continues to outweigh the risks.  Consideration should be given to use of other approved therapies to control the patients’ psoriasis.
• The effects of periodic or intermittent use of Raptiva, or the concomitant use of other immunosuppressant drugs on the risk for PML is not known.

Patients using Raptiva should:

• Be aware that Raptiva increases the risk of developing PML.  PML is a disease that is fatal or causes severe disability.
• Talk with their healthcare provider about the benefits and risks of treatment with Raptiva.
• Be aware of the symptoms of PML which may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and sometimes personality changes.
• Contact their healthcare provider immediately if they experience these symptoms.
• Understand that there are no laboratory screening tests for PML or medical interventions that can prevent or treat PML

The FDA asks health care providers and patients to report possible cases of PML to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html.

Nationwide Raptiva (efalizumab) Lawsuits

Raptiva (efalizumab), a drug used to treat psoriasis, manufactured by Genentech, has recently been linked to the development of progressive multifocal leukoencephalopathy (PML). Progressive multifocal leukoencephalopathy, also known as PML is a life-threatening brain infection that often leads to death among those diagnosed.

2009 FDA Raptiva Warning

On February 19, 2009, the FDA issued an urgent, nationwide warning to physicians and patients regarding the confirmed diagnosis of PML in three psoriasis patients being treated with Raptiva. According to FDA documents, all three patients died as a result of the PML brain infection. To read more about the February 2009 FDA Raptiva Warning, click here.

2008 FDA Raptiva “Black Box Warning”

The most recent warning was not the first time Raptiva has come under FDA scrutiny. In October 2009, the FDA issued a “Black Box Warning”, the strongest warning possible for an FDA approved drug. Within the 2008 warning, the FDA required the manufacturers of Raptiva make changes to the labeling of Raptiva to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML). The labeling changes were based on the FDA’s post-market surveillance program and suspected adverse events (including PML) reported to the FDA. The FDA also required the manufacturer to prepare a submission of a Risk Evaluation and Mitigation Strategy (REMS), that included a Medication Guide for patients and a timetable for assessment of the REMS. To read more about the 2008 FDA Raptiva Black Box Warning, click here.

Progressive Multifocal Leukoencephalopathy (PML) Overview

Progressive multifocal leukoencephalopathy, also known as PML is a neurological disorder that often times leads to serious brain damage and/or death. According to an WebMD, “The term “progressive” in PML means that the disease continues to get worse and often leads to serious brain damage. The term “multifocal” means that JCV causes disease in multiple parts of the brain. However, it is possible for an individual with PML to have only one brain lesion instead of several lesions. The term “leukoencephalopathy” means that the disease affects mainly the white matter of the brain or myelin, although there are some rare cases in which the gray matter neurons is also involved.”

Signs & Symptoms of Progressive Multifocal Leukoencephalopathy (PML)

The following is a list of the signs and symptoms related to Progressive Multifocal Leukoencephalopathy:

• Mental deterioration
• Vision loss
• Speech disturbances
• Ataxia
• Paralysis
• Coma
• Seizures
• Muscle weakness
• Hemiparesis
• Facial weakness
• Dysphasia
• Memory failure
• Cognition failure

Progressive Multifocal Leukoencephalopathy & Raptiva Lawsuit - Your Legal Rights

If you or somebody you know has developed Progressive Multifocal Leukoencephalopathy or PML, you should contact one of our Raptiva attorneys as soon as possible. Regardless of your situation, you are sure to have questions. The only way to get your questions answered is to learn your legal rights and that is where our Raptiva lawyers come in.

An experienced mass tort law firm can answer your questions and provide you with a free case evaluation regarding the potential to seek financial recovery through litigation. While we understand that a financial recovery will not bring back a loved one or compensate for a lifelong disability, we also urge you to exercise your right to seek legal counsel regarding your potential Raptiva lawsuit.

Please use the form below to contact one of our Mass Tort attorneys handling Raptiva claims.