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Raptiva Recall News Blog 
Tuesday, 28 April 2009
Raptiva Contraindications

....treatment period with RAPTIVA maintained PASI-75 response compared with 8 of 40 patients (20%) re-randomized to placebo. Sustained responses to RAPTIVA have also been observed in uncontrolled, open-label extension treatment trials when patients received RAPTIVA without interruption for 24 weeks.

In Study 2, response to intermittent RAPTIVA treatment was evaluated among patients who achieved PASI-75 response with 12 weeks of RAPTIVA treatment and were followed off-treatment until relapse of psoriasis (50% loss of treatment response). In patients who resumed RAPTIVA treatment upon relapse of psoriasis, 31% (17/55) re-established a PASI-75 response (compared with the initial baseline). After 12 weeks of treatment, the median duration of a PASI-75 response after RAPTIVA discontinuation was between 1 and 2 months. The safety and efficacy of RAPTIVA therapy beyond 1 year have not been established.

 

INDICATIONS AND USAGE

RAPTIVAŽ (efalizumab) is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

 

CONTRAINDICATIONS

RAPTIVA should not be administered to patients with known hypersensitivity to RAPTIVA or any of its components.

 

WARNINGS

Serious Infections

RAPTIVA is an immunosuppressive agent and has the potential to increase the risk of infection and reactivate latent, chronic infections. RAPTIVA should not be administered to patients with clinically important infections. Caution should be exercised when considering the use of RAPTIVA in patients with a chronic infection or history of recurrent infections. If a patient develops a serious infection, RAPTIVA should be discontinued. New infections developing during RAPTIVA treatment should be monitored closely. During the first 12 weeks of controlled trials, serious infections occurred in 7 of 1620 (0.4 %) RAPTIVA-treated patients compared with 1 of 715 (0.1%) placebo-treated patients (see ADVERSE REACTIONS, Infections). Serious infections

 

See Raptiva Page 7

POSTED BY: DW AT 09:38 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.