Raptiva Linked to Life Threatening Infections and PML Raptiva (efalizumab), a psoriasis drug, has been linked to life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy ( PML ) and other opportunistic infections with the use of Raptiva. Raptiva has been withdrawn from the market .
In October of 2008 the Food and Drug Administration added a black box warning to the drug which says it increases the risk of life-threatening infections such as bacterial sepsis, viral meningitis, invasive fungal disease and even PML, a disorder usually seen in patients with immune deficiencies. It is caused by a virus that affects the central nervous system and leads to an irreversible decline in neurologic function and death.
According to Genetech, the manufacturer of Raptiva,
Progressive multifocal leukoencephalopathy (PML) is a rare, progressive, demyelinating disease of the central nervous system that usually leads to death or severe disability.
It is presently not possible to identify patients at increased risk of PML prior to or during RAPTIVA therapy.
PML has been reported in the literature in HIV- positive patients, immunosuppressed cancer patients (including those with hematologic malignancies), organ transplant recipients, and patients with autoimmune disease
There are currently no effective therapeutic options to treat PML.
PML is caused by activation of the JC virus, a polyomavirus that resides in latent form in up to 80% of healthy adults. JC virus usually remains latent, typically only causing PML in immunocompromised patients. The factors leading to activation of the latent infection are not fully understood.
There is no currently accepted screening test for PML.
Raptiva Lawsuit Information and Free Raptiva Lawyer Consultation
If you or a loved one has taken Raptiva and been diagnosed with infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy ( PML ) then you should call us toll free now at 1-866-374-0338 because you may be entitled to medical monitoring and compensation from the manufacturer.
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Raptiva Brain Infection PML FDA NEWS - Recall
FOR IMMEDIATE RELEASE April 8, 2009
FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market
Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive 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.
Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.
The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. 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. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.
Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.
Raptiva Infections and PML News FDA
LATEST NEWS
Oct. 16, 2008
FDA Approves Updated Labeling for Psoriasis Drug Raptiva Safety concerns drove labeling changes
Raptiva (efalizumab)
Audience: Dermatological healthcare professionals, patients
[Posted 10/17/2008] FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections with the use of Raptiva. In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.
Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay. Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug.
Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva
Raptiva - Brain Infection - PML 
Raptiva (efalizumab), a psoriasis drug, has been linked to life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy ( PML ) and other opportunistic infections with the use of Raptiva. Raptiva has been withdrawn from the market . 
