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Injured by Raptiva?
Raptiva (Generic: Efalizumab) is a humanized monoclonal antibody targeted toward the hyperproliferative pathology of psoriasis. As an immunosuppressive agent, Raptiva "has the ability to enhance the threat of infection and reactivate latent, chronic infections," the label cautions. Serious infections and malignancies reported in patients taking Rapitva include malignant melanoma and non-melanoma skin cancer, non-cutaneous solid tumors, and lymphomas.On, July 20, 2005, the FDA announced a new warning on the Genentech psoriasis drug Raptiva (efalizumab) following reports of four cases of hemolytic anemia that were diagnosed four to six months after patients started on the monoclonal antibody. Two of the cases occurred during clinical trials of Raptiva, and the other two were reported as post-marketing events, according to the FDA.
In a "Dear Healthcare Provider" letter issued July 20, Genentech reported that in two severe cases, hemoglobin levels dropped to 6 and 7 g/dL. "A causal relationship between Raptiva and these events has not been established but cannot be excluded," the letter said.
The package insert for Raptiva was modified to include a warning to stop use of the drug should hemolytic anemia occur. In addition, the information sheet has been updated to include news of post marketing reports of necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infections such as pneumonia despite antimicrobial therapy.
If you or a loved one took Raptiva and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
RaptivaRSS Feed
Raptiva No Longer Available in Canada
Jun 18, 2009 | Parker Waichman Alonso LLP
Raptiva has been pulled from the market in Canada because of its association with an often-fatal brain infection called progressive multifocal leukoencephalitis (PML). The suspension of Raptiva sales in Canada is part of a global withdrawal of the drug.Raptiva works by blocking the activation of certain immune cells called T cells, and the migration of those cells into the skin. However, by suppressing the body’s natural defense system, it can also increase the risk of serious...
Raptiva Pulled from U.S. Market Following PML Deaths
Apr 8, 2009 | Parker Waichman Alonso LLP
Raptiva, an injectable drug used to treat moderate to severe plaque psoriasis, is being withdrawn from the U.S. market. According to Genentech, Raptiva has been associated with progressive multifocal leukoencephalopathy (PML), a serious and almost always fatal brain infection caused by a virus.Raptiva was approved by the U.S. Food & Drug Administration (FDA) in 2003. Raptiva works by blocking the activation of certain immune cells called T cells, and the...
Raptiva Sales Suspension Recommended in Europe After Reports of Brain Infections
Feb 20, 2009 | Parker Waichman Alonso LLP
On the same day U.S. regulators warned that the psoriasis drug Raptiva had been linked to three fatal case of a rare brain infection, their counterparts in the European Union have recommended sales of the drug be suspended. In a statement, advisers to the European Medicines Agency (EMEA) said that in light of the deaths, Raptiva's benefits do not outweigh its risks.Raptiva is an injectable drug that was approved by the U.S. Food & Drug Administration (FDA) in 2003 to treat...
Raptiva Linked to Deadly Brain Disease
Feb 19, 2009 | Parker Waichman Alonso LLP
U.S. health regulators warned today that the psoriasis drug Raptiva has been associated with three fatal cases of a brain infection known as progressive multifocal leukoencephalopathy, or PML. The Food & Drug Administration (FDA) also said it was aware of a possible fourth Raptiva patient who may have developed the deadly brain disease.Raptiva is an injectable drug that was approved by the FDA in 2003 to treat moderate to severe plaque psoriasis. Raptiva works by blocking the...
Raptiva Gets Black Box Warning for PML, Other Opportunistic Infections
Oct 17, 2008 | Parker Waichman Alonso LLP
The labeling of the psoriasis drug Raptiva will now bear a new black box warning about its association with the deadly brain disease progressive multifocal leukoencephalopathy, or PML, and other life threatening infections. The Food & Drug Administration (FDA) ordered the black box after receiving reports of serious infections - including at least one case of PML - in some patients taking Raptiva.Raptiva is an injectable drug that was approved by the Food & Drug...
Raptiva
Quick Facts
Raptiva Reference Guide
Generic Name
Efalizumab
Date Approved
October 27, 2003
Manufacturer
Genentech, Inc
Status
Warning July 20, 2005
Approved Uses
Psoriasis
Serious Side Effects
Malignant melanoma
Tumors
Hemolytic anemia
Related Topics
Defective Drugs
Efalizumab
Date Approved
October 27, 2003
Manufacturer
Genentech, Inc
Status
Warning July 20, 2005
Approved Uses
Psoriasis
Serious Side Effects
Malignant melanoma
Tumors
Hemolytic anemia
Related Topics
Defective Drugs
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