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Raptiva Psoriasis Drug PML Brain Infection Deaths


On April 8, 2009, Raptiva was voluntarily withdrawn from the market by its manufacturer, Genentech. The drug was discontinued due to the risk of Raptiva PML (progressive multifocal leukoencephalopathy), a rare and serious progressive neurologic disease. The risk of developing such a serious Raptiva side effect caused enough concern that the drug was removed from the market after the US Food and Drug Administration (FDA) issued a Public Health Advisory about the medication.

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Raptiva Side Effects

On February 19, 2009, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory concerning four reports of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients died and all four patients were treated with Raptiva for more than three years. None of the patients were receiving other treatments that suppress the immune system.

On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information regarding the risk of PML in patients using the medication. On October 2008, Raptiva's label was changed to highlight the risk of life-threatening infections, including PML. Around the same time, Genentech was told to develop a Risk Evaluation and Mitigation Strategy (REMS) to ensure patients received vital information about Raptiva.

Those steps, however, were not enough and on April 8, 2009, Raptiva was voluntarily withdrawn from the market.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy.

PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. There is no known effective prevention or treatment.

Raptiva Lawsuit

Raptiva lawsuits have been filed against Genentech, a division of Roche Holdings AG, alleging patients were harmed by the use of the drug. In January 2012, reports surfaced that Genentech had settled at least one lawsuit, but Roche Holdings denied that report and a lawyer for the plaintiff later stated he spoke in error.

As of January 13, 2012, approximately 100 Raptiva lawsuits were consolidated in state court in Oakland, CA, with other lawsuits reportedly pending in federal and state courts in Texas and Massachusetts, according to Bloomberg (01/13/12).

Lawsuits allege Genentech downplayed the risks associated with Raptiva.

Raptiva PML Brain Infection Legal Help

If you or a loved one has suffered or is suffering adverse health effects such as PML from using this drug, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
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RAPTIVA BRAIN INFECTION LEGAL ARTICLES AND INTERVIEWS

Raptiva Lawsuits Cause of Controversy
Raptiva Lawsuits Cause of Controversy
January 10, 2013
Oakland, CARaptiva lawsuits, alleging patients suffered serious harm and life-threatening Raptiva side effects, caused some controversy in 2012, when a plaintiff's lawyer erroneously announced a Raptiva lawsuit had been settled. The lawsuit, alleging one patient developed so-called Raptiva PML (progressive multifocal leukoencephalopathy), was initially scheduled for court in January but was later pushed back to June.
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Raptiva Pulled from Market Due to Concerns About Side Effects
Raptiva Pulled from Market Due to Concerns About Side Effects
December 17, 2012
San Antonio, TX It has been more than three years since Raptiva was voluntarily withdrawn from the market due to concerns about serious Raptiva side effects. Specifically, the drug was pulled after reports surfaced of a reported increased risk of Raptiva PML (progressive multifocal leukoencephalopathy), a rare progressive neurologic disease that is often fatal. Even though Raptiva was pulled from the market three years ago, lawsuits were scheduled to go to court in 2012.
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Why Raptiva was Withdrawn
Why Raptiva was Withdrawn
June 8, 2009
Daly City, CA After getting FDA approval in 2003, Raptiva was used to treat about 46,000 patients worldwide. In April, Genentech's immunosuppressant for psoriasis was withdrawn from the market after it was associated with progressive multifocal leukoencephalitis (PML)—a rare brain disease. So far only three cases have been associated with the drug, but PML is often undiagnosed or misdiagnosed. And given the amount of patients prescribed Raptiva, the drug may be withdrawn but we likely haven't heard the last of it…
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