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Raptiva Recall News Blog 
Tuesday, 28 April 2009
Raptiva PML Reported in Study

requiring hospitalization included cellulitis, pneumonia, abscess, sepsis, bronchitis, gastroenteritis, aseptic meningitis, Legionnaire's disease, and vertebral osteomyelitis (note some patients had more than one infection).

 

Progressive Multifocal Leukoencephalopathy (PML) has been reported in a post-marketing study. Physicians treating patients with RAPTIVA should consider PML in any patient with new-onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated. Patients being treated with RAPTIVA should be instructed to report any new neurological signs or symptoms to their physician. RAPTIVA should be discontinued in patients who develop PML.

 

In postmarketing experience, serious bacterial, viral, fungal, and opportunistic infections have occurred, including pneumonia, sepsis, meningitis, and encephalitis. Some of these infections have been fatal. Postmarketing reports include cytomegaloviral infections; blastomyces, cryptococcal and tuberculous pneumonia; serious herpes infection; severe pneumonia with neutropenia (ANC 60/mm3); sepsis with seeding of distant sites; necrotizing fasciitis; and worsening of infection (e.g. cellulitis, pneumonia) despite antimicrobial treatment.

 

Malignancies

RAPTIVA is an immunosuppressive agent. Many immunosuppressive agents have the potential to increase the risk of malignancy. The role of RAPTIVA in the development of malignancies is not known. Caution should be exercised when considering the use of RAPTIVA in patients at high risk for malignancy or with a history of malignancy. If a patient develops a malignancy, RAPTIVA should be discontinued (see ADVERSE REACTIONS, Malignancy).

 

Immune-Mediated Thrombocytopenia

Platelet counts at or below 52,000 cells per ěL were observed in 8 (0.3%) RAPTIVA-treated patients during clinical trials compared with none among the placebo-treated patients (see ADVERSE REACTIONS, Immune-Mediated Thrombocytopenia). Five of the 8 patients received a course of systemic steroids for thrombocytopenia. Thrombocytopenia resolved in the 7 patients receiving adequate....

 

See: Raptiva Page 8

POSTED BY: DW AT 09:39 pm   |  Permalink   |  E-mail this
Raptiva / efalizumab recalled by FDA Raptiva Recall News about Get latest Raptiva PML side effects warnings and RaptivaLawsuit Update. Raptiva increases the risk of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, and progressive multifocal leukoencephalopathy (PML). PML is a viral disease that causes irreversible brain damage and death. Raptiva was on the market for 5 years before the public was warned about these risks. Talk to a Raptiva Lawyer or Raptiva Attorney to File a Raptiva Lawsuit & Raptiva Class Action Lawsuit. Raptiva or efalizumab has been reported to cause serious rare brain infections, PML and other raptiva side effects, progressive multifocal leukoencephalopathy (pml) Talk to a raptivalawyer about a raptivalawsuit today.

Raptiva Recall Announced by FDA on April 8, 2009

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Raptiva recalled by FDA due to serious Raptiva related injuries. Talk to a Raptiva lawyer about filing a raptiva lawsuit if you took raptiva and have been diagnosed with PML, meningitis, encephalitis, a Lymphoma, Hodgkin's Disease, Rebound or worse Psoriasis, severe psoriasis, death, paralysis, resulting in disability (after cessation of Raptiva usage) or Serious infections (bacterial or viral)resulting in hospitalization.Talk to us about the pros and cons of a raptiva class action lawsuit. Get Raptiva drug information update for any victim of raptiva.