Raptiva
Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The drug works by suppressing T-cells in the immune system.
On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. Progressive Multifocal Leukoencephalopathy (PML) is a serious, progressive neurologic disease caused by a virus that affects the central nervous system. Genentech, the manufacturer of the drug Raptiva (efalizumab), announced on April 8, 2008 that it has begun a voluntary phased withdrawal of Raptiva from the United States market. The company is taking this action after learning of a potential risk to patients of developing PML.
On Oct. 16, 2008, the FDA updated the labeling for Raptiva to warn of the risk of life-threatening infections, including PML. PML usually occurs in people whose immune systems have been severely weakened. By June 8, 2009, Raptiva will no longer be available in the United States.
Symptoms of PML may include:
- unusual weakness
- loss of coordination
- changes in vision
- difficulty speaking
- personality changes
There is no known effective prevention or treatment for PML. PML leads to an irreversible decline in neurologic function and death.
If you have legal concerns regarding Raptiva, call today at (800)555-4011 for your free consultation, or you can contact us here.