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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 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 Added to List of Drugs Linked to Deadly Brain Disease
Oct 6, 2008 | Parker Waichman Alonso LLPp
Raptiva, Genentech Inc’s psoriasis drug, may be linked to a deadly brain disease called progressive multifocal leukoencephalopathy, or PML. The company sent a letter to healthcare providers last week warning that one Raptiva patient had been diagnosed with the disease, while another had died of unknown causes after developing neurological symptoms.Raptiva is an injectable drug that was approved by the Food & Drug Administration (FDA) in 2003 to treat moderate to severe plaque...
Reports of Severe Anemia, Infections, and Rare Blood Disease Prompt New Safety Warning for Psoriasis Drug Raptiva
Jul 21, 2005 | www.newsinferno.com
The FDA and Genetech have issued a new safety warning for the psoriasis drug Raptiva which addresses serious potential side effects of the drug including: immune-mediated hemolytic anemia, in which the immunes system mistakes red blood cells for foreign cells and attacks them; and the blood disease thrombocytopenia, which causes a low level of blood clotting cells called platelets.Despite two cases of hemolytic anemia in clinical trials, Raptiva was approved by the FDA in October 2003 for the...
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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