Product Liability

Rheumatoid Arthritis drug linked to serious neurological disorder

The Food and Drug Administration (FDA) has received a third case of a serious and often fatal neurological disorder known as progressive multifocal leukoencephalopathy (PML) in a patient with rheumatoid arthritis (RA) treated with the drug Rituxan (rituximab). The report has led the agency to inform rheumatological health care professionals that patients with RA who have received Rituxan are at an increased risk of PML. Physicians should consider the risks in any patient treated with Rituxan who presents new onset neurological manifestations. The FDA advises consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated.

Rituxan is prescribed for the treatment of RA and non-Hodgkins lymphoma. Last month, the FDA issued an alert to neurological health care professionals about Tysbri (Natalizumab), a drug to treat relapsing forms of multiple sclerosis (MS) and Crohn’s disease. The alert informed health care providers of an increased risk of PML in patients with MS treated with Tysbri.

PML is a rare, progressive, demyelinating disease of the central nervous system that usually leads to death or severe disability. PML is caused by activation of the JC virus. JC virus resides in latent form in 40-80 percent of healthy adults. The factors leading to activation of the latent infection are not fully understood. PML has been reported in HIV-positive patients, immunosuppressed cancer patients, transplantation patients and patients with autoimmune diseases. There are no known interventions that can reliably prevent or adequately treat PML.

Patients with any questions regarding the use of Rituxan, please refer to the Rituxan Product Information at www.gene.com, or call the company’s Medical Information/Communications Department at 1-800-821-8590.