Raptiva Side Effects
Genentech has announced a voluntary, phased withdrawal of Raptiva from the U.S. market due to the potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare but serious, neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.
Background:
Raptiva (efalizumab) was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe psoriasis. Psoriasis is a chronic immune system disorder that causes inflammation of the skin. This inflammation results in skin problems such as redness, itching or burning. Patients with psoriasis experience a situation in which their immune system sends faulty signals that increase the rate at which skin cells are grown.
Since the approval of Raptiva, the FDA has received reports of three confirmed cases and one possible case of progressive multifocal leukoencephalopathy (PML) in patients who were 47 to 73 years old using Raptiva for the treatment of psoriasis. Two of the patients with confirmed PML and one patient with possible PML died. All four patients were treated with Raptiva continuously for more than three years.
In October 2008, the labeling for Raptiva was changed to include a boxed warning relating to the risks of life-threatening infections, including PML. In addition, the FDA directed Genentech to develop a Risk Evaluation and Mitigation Strategy (REMS) to ensure patients receive risk information about Raptiva.
Symptoms and signs of neurological problems that could develop include the following:
- Confusion
- Dizziness
- Loss of balance
- Seizures
- Difficulty walking or talking
If you or someone you has experienced any adverse effects from their use of Raptiva, you should immediately consult your physician. You may also want to consider your potential legal claim. If you would like more information, click here to fill out a free case review form or call attorney Stacy Hauer at 800.755.0098. Zimmerman Reed is experienced in handling defective pharmaceutical drug cases and we welcome any questions you may have. 
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