Raptiva - Brain Injuries

Florida Raptiva Brain Injury Attorneys

Searcy Denney Firm Prepared to Represent Psoriasis Patients Who Have Taken Raptiva; Drug Touted to Relieve Psoriasis Symptoms Instead Poses Risk of Fatal Neurological Disease

For the 125 million people worldwide with psoriasis, almost any panacea is welcome to combat the itching, bleeding, ugly skin patches and silvery scales that can make going out in public a miserable experience.

There is no cure for this debilitating skin condition. But since a drug called Raptiva was approved by the FDA in 2003, more than 46,000 psoriasis sufferers worldwide have used the drug to alleviate the severity of their symptoms.

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Raptiva (generic name efalizumab) is used primarily by patients with the most common type of psoriasis - plaque psoriasis, which affects 80% of all psoriasis sufferers. Raptiva is injected once a week to block the activation, reactivation, and trafficking of T cells in the immune system that lead to psoriasis. By suppressing T cells, however, Raptiva diminishes a patient's immune system. This, in turn, increases susceptibility to infection.

The first warning signs about Raptiva came in October 2008, when manufacturer Genentech updated prescribing information about Raptiva to include a warning about the risk of serious infection - including Progressive Multifocal Leukoencephalopathy (PML). PML is a rare and usually fatal disease of the central nervous system. In the face of increasing concern, Raptiva's prescribing information was updated once more, in March 2009, with additional information about the risk of PML and introduction of a new Medication Guide to provide better warnings directly to patients.

Only after four patients receiving Raptiva died - three diagnosed with PML and one who had developed progressive neurologic symptoms - did Genentech implement a phased voluntary withdrawal of this drug from the U.S. market (April 2009). In the meantime, the company's U.S. revenues had soared to $108 million for the previous year.

The impact of the Raptiva recall, and the ramifications of the drug's link with PML, are staggering. The National Psoriasis Foundation estimates that psoriasis affects two to three percent of the world's population - 5.8 to 7.5 million Americans alone. Psoriasis is not a cosmetic problem solved by covering up its recurring red scaly patches and excessive skin production. Nearly 60% of psoriasis patients surveyed report that it is a large problem in their everyday life. And although it is not contagious, because of its appearance, psoriasis often severely limits a patient's ability to appear in public and interact with other people.

Progressive Multifocal Leukoencephalopathy (PML), the brain disease linked to Raptiva use, is caused by a virus that seriously compromises the central nervous system. It leads to an irreversible decline in neurologic function, and is almost always fatal; people who do live are severely disabled. Symptoms include changes in vision and personality; weakness and clumsiness or loss of coordination; and difficulty speaking. PML is most likely to strike people with weakened immune systems - such as psoriasis sufferers whose immune systems have been weakened by long-time, continuous injections of Raptiva. The three deaths positively attributed to Raptiva occurred after more than three years of the drug's use, and death occurred less than a year after the symptoms were first identified as PML.

As if the risk of PML were not enough, the European Medicines Agency has reported additional serious side effects linked to Raptiva. These include Guillain Barre and Miller Fisher syndromes, which damage the nerves; encephalitis (inflammation of the brain); encephalopathy (brain damage); meningitis (inflammation of the membrane surrounding the brain); and an array of other maladies that include sepsis and tuberculosis.

Raptiva has not been sold in the United States since June 8, 2009. But what happens to the 2,000 Americans with psoriasis who, according to Genentech estimates, were using Raptiva at the time of the recall?

Unfortunately, suddenly going "cold turkey" in stopping Raptiva injections can lead to severe worsening of the psoriasis and serious side effects that could require hospitalization. The National Psoriasis Foundation has issued a statement to that effect:

     The National Psoriasis Foundation recommends patients currently using Raptiva (efalizumab) to immediately contact their dermatologist and find an alternative treatment option. Patients should not stop using Raptiva without speaking with their physician - stopping abruptly could lead to a severe psoriasis flare.

In its patient letter, Genentech is also telling Raptiva users not to stop the injections without first talking with their doctor about the dangers and other options for treatment. Genentech recommends that, for the limited time patients are still taking Raptiva, they should read carefully the Medication Guide in the drug package so that they will be aware of the symptoms of PML.

However, Raptiva use should be discontinued immediately at the first appearance of PML symptoms. Unfortunately, there are no laboratory screening tests for identifying PML, or medical interventions that prevent or treat it.

At Searcy Denney Scarola Barnhart & Shipley, our attorneys understand all too well the devastation that occurs when a family member or other loved one is struck down by an unsafe pharmaceutical. We also have learned first-hand how aggressive pharmaceutical companies use their money and power to block innocent victims from having their day in court. However, we not only have the courage to stand up to powerful opponents; we have the capacity to serve our clients with meticulous investigation and case preparation to support their quest for justice.

Contact us for more information or a free consultation with an experienced Florida Raptiva / brain injury lawyer.

If you or a family member has used Raptiva for psoriasis and is experiencing symptoms of neurological disorders, or if a loved one has died from PML, the attorneys at Searcy Denney would be happy to discuss your potential case. Please fill out our contact form, or call us to learn more and arrange for a confidential free consultation.

 

Related Links:

Genentech Announces Voluntary Withdrawal of Raptiva from the U.S. Market

FDA Statement on the Voluntary Withdrawal of Aptiva From the U.S. Market

FDA Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva

Raptiva Medication Guide and Full Prescribing Information

National Psoriasis Foundation

 

 

 

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