The United States Food & Drug Administration (FDA) issued a Public Health Advisory on February 19, 2009 regarding life-threatening side-effects associated with the psoriasis drug Raptiva (efalizumab). The alert linked Raptiva to progressive multifocal leukoencephalopathy (PML), a rare disease of the central nervous system that leads to death or severe disability. Two months later, Genentech and the FDA announced the withdrawal of Raptiva from the U.S. market. If you have suffered from severe side-effects after taking the psoriasis drug, Raptiva attorneys may be able to help you puruse compensation.
Help Resource Center
Psoriasis and Raptiva (efalizumab)
Raptiva (efalizumab), manufactured by Genentech, a member of the Roche Group, is a prescription drug for the treatment of moderate to severe plaque psoriasis. Plaque psoriasis sufferers endure itching and/or burning patches of inflamed skin.
The FDA approved Raptiva in 2003 as a once-weekly therapy for continuous treatment of moderate-severe plaque psoriasis. Raptiva suppresses the immune system and therefore, can increase the risk of infection. In patients with a weakened immune system, Raptiva has been associated with an increased risk of developing progressive multifocal leukoencephalopathy (PML).
Progressive Multifocal Leukoencephalopathy (PML) Development Factors
- Caused by reactivation of a virus commonly found in the central nervous system
- Polyomavirus JC (JC virus) present in majority of population and generally harmless
- JC virus harmful to those with weakened immune systems
- PML most commonly occurs in AIDS patients
- Rarely occurs in organ transplant patients, individuals with cancer, and people receiving chronic corticosteroid orimmunosuppressive therapy
Raptiva Brain Injury Symptoms
- May develop over days or weeks
- Progressive weakness to one side of the body
- Lack of coordination in arms and legs
- Vision changes
- Memory loss
- Behavior and personality changes
Raptiva Side Effects
In addition to an increased risk of developing progressive multifocal leukoencephalopathy (PML), patients taking Raptiva may experience additional side effects, including:
- Signs of infection, including chills, fever, and easy bruising or bleeding
- Muscle pain
- Infection (mostly upper respiratory)
- Invasive Fungal Disease
- Bacterial Sepsis
- Viral Meningitis
- Lymphoma and Other Cancers (such as Hodgkin’s Lymphoma, Non-Hodgkin’s Lymphoma, Colon Cancer and other malignancy)
- Neurological complications
Timeline of Raptiva Side Effects and Warnings
- March 2003 – Phase III studies conclude that Raptiva reduces psoriasis.
- October 2003 – FDA approves Raptiva.
- July 2005 – FDA revises Warnings and Adverse Reactions sections for Raptiva due to reports of immune-mediated hemolytic anemia, a condition where the patient’s immune system begins attacking his/her own red blood cells. The Warnings section was also updated to include reports of thrombocytopenia and serious infection (including bacterial sepsis, tuberculous pneumonia, and necrotizing fasciitis, commonly known as flesh-eating disease or Flesh-eating bacteria).
- October 2008 – FDA notified healthcare professionals of extensive labeling changes, specifically alerting to the risks of life threatening infections including viral meningitis, bacterial sepsis and PML. New changes instructed patients to report any new neurological symptoms to their physician.
- February 2009 – Genentech and FDA notify healthcare professionals of the complete withdrawal of Raptiva from U.S. market by June 2009 over growing PML concerns.
- June 2009 – Raptiva no longer available in U.S.
If you or a loved one was prescribed Raptiva and developed harmful side effects, including PML brain infection or death, Raptiva attorneys may be able to help you pursue a Raptiva lawsuit for compensation. Call 1-888-BURNETTI for more information