What action is the FDA taking with Rituxan today?
The Food and Drug Administration (FDA) yesterday issued a public health advisory and a Dear Health Care Provider information sheet to inform patients, their families, the general public, and the medical community of new reports of a serious viral infection (progressive multifocal leukoencephalopathy or PML) in patients with an autoimmune disease (systemic lupus erythematosus [SLE]), who have been treated with Rituxan. Rituxan is not approved for the treatment of SLE. 2. What is PML? PML stands for progressive multifocal leukoencephalopathy, which is a rare, progressive, infection of the brain that is caused by reactivation of a virus (the JC virus). Up to 80% of healthy adults have been infected with this virus at some point during childhood but the JC virus normally remains in the body in an inactive (latent) state. However, the JC virus can become active and cause illness when the body’s immune system (natural defenses against infection) is impaired by illness or medications. This is
