RAPTIVA (efalizumab) - Protecting Your Rights with the Help of a Qualified Raptiva Attorney
Genetech’s injectible drug, Raptiva (efalizumab,) was approved by the FDA on October 17, 2003 for the treatment of moderate to severe plaque psoriasis.
From the beginning, side effects associated with the drug could be severe. A cluster of symptoms that included headache, fever, nausea, chills and muscle pain or weakness often occurred within two days of the first dose. 29% of patients experienced this aggregate of symptoms after the initial dosage.
In March of 2003, Genetech touted Raptiva’s “emerging safety profile.” Yet in multiple pre-marketing clinical trials, the following severe adverse events were more prevalent in patients receiving Raptiva than in those receiving placebos.
- Infections such as abscesses, septic arthritis, pneumonia, sinusitis, gastroenteritis, bronchitis, cellulitis, aseptic meningitis, vertebral osteomyelitis and Legionnaire’s disease
- Malignancies such as non-malignant melanoma, non-melanoma skin cancer, Hodgkin’s lymphoma and non-Hodgkin’s lymphoma
- Immune-Mediated Thrombocytopenia (a low platelet count)
- Immune-Mediated Hemolytic Anemia (anemia caused by the destruction of red blood cells)
- Arthritis
- Hypersensitivity such as asthma, angioedema, dyspnea and urticaria
In July of 2005, Genetech added new safety information to the drug’s label to warn of potential risks such as:
- Hemolytic anemia
- Fasciitis (flesh eating bacteria)
- Tuberculous pneumonia
- Bacterial sepsis (blood poisoning)
As time progressed, other potentially deadly side effects began to emerge, including:
- Opportunistic bacterial, viral and fungal infections such as the JC virus responsible for the central nervous system disease known as PML (Progressive Multifocal Leukoencephalopathy – a fatal brain disease)
- Recurrent severe arthritis
- Lymphoma
- Guillain-Barre Syndrome (the body’s immune system attacking the nerves)
- Facial palsy
Even if treatments were quickly stopped, other side effects such as general body pain, joint pain and arthritis could occur. The drug’s effect on the immune system could be catastrophic.
On October 16, 2008, the FDA issued a Black Box warning for Raptiva requiring labels that warned of the risks of life-threatening infections such as PML. On February 19, 2009, following the deaths of three patients from PML, the FDA issued a Public Health Advisory to patients and physicians. An approved Medication Guide for Raptiva followed on March 19, 2009, and on April 8, 2009, Genetech began a phased withdrawal of Raptiva from the market.
As of June 8, 2009, the drug is no longer prescribed in the United States.
Side effects from Raptiva can manifest years after drug initiation and can be potentially fatal. Raptiva lawsuits are on the rise as victims continue to battle serious post-Raptiva adverse conditions. Those ill affected by Raptiva are entitled to have their rights protected.
If you or someone you know has taken Raptiva and experienced adverse side effects, use the form below for a free evaluation with an expert Raptiva lawyer. Unsafe drug cases are complex, and guidance by a qualified Raptiva attorney is crucial. The sooner you contact us, the sooner we can help.
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