Biogen's RITUXAN and PML! Biogen also makes Tysabri

[Guest guest]

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labeling for Rituxan is being revised following a report that a patient

administered the drug to treat rheumatoid arthritis had died of the

brain infection progressive multifocal leukoencephalopathy (PML). Cases

of PML have previously been reported in patients taking Rituxan for

unapproved uses, such as blood cancer and lupus. But according to the

Food & Drug Administration (FDA), this is the first report of the

infection in an individual undergoing treat for arthritis.In addition to rheumatoid arthritis, Rituxan is approved to treat non-Hodgkins Lymphoma. PML

is characterized by the progressive inflammation of the brain and

central nervous system. Patients with PML exhibit neurological symptoms

like confusion, dizziness or loss of balance, difficulty talking or

walking, and vision problems. PML gets worse over time, and is

usuallyfatal. There is no treatment or cure for the disease. PML

is caused by a polyomavirus, called the JC virus. The JC virus is often

acquired during childhood. Most adults have been infected with the JC

virus but do not develop PML. The virus appears to remain inactive

until something (such as a weakened immune system) allows it to be

reactivated and start to multiply. Rituxan

is a powerful medication that suppresses the immune system. In February

2006, the labeling of Rituxan was updated to include information about

the risks of patients contracting several viral infections, including

PML.The FDA also cautioned

physicians who were considering treating a patient with Rituxan for any

condition to inform the patient of the risk of developing PML. Last year, the FDA warned that two patients taking Rituxan off-label for systemic lupus erythematosus had died from PML. This

latest PML-Rituxan fatality involved a woman taking the drug for

rheumatoid arthritis. According to the FDA, the patient was undergoing

chemotherapy and radiation treatment for cancer in the months before

she developed the infection. The agency said the patient received

Rituxan in a long-term safety extension clinical study. According to

the FDA, the patient developed a JC virus infection with resultant PML

and death 18 months after taking the last dose of Rituxan. In

a letter sent to healthcare providers, Genentech and Biogen I..he

makers of Rituxan, advised doctors to consider PML in any patient

presenting with new onset neurologic manifestations. Consultation with

a neurologist, brain MRI and lumbar puncture should be considered as

clinically indicated. Rituxan should be discontinued immediately in

patients who develop PML, the letter said. Ritixan

is not the only Biogen Idec drug to be associated with PML. Earlier

this summer, the FDA warned that the same brain disease had been

associated with Tysabri, a drug for multiple sclerosis (MS) that Biogen

Idec markets in a joint effort with Elan Inc. The FDA warning was

prompted by reports of two European MS patients undergoing Tysabri

monotherapy had developed PML. In

the U.S. Tysabri was taken off the market in 2005 after three patients

in clinical trials developed PML. But the drug was reapproved in 2006,

although it was subject to restrictions. The new European cases of

Tysabri-related PML raised alarms because both patients had been taking

Tysabri as monotherapy - with no other drugs. It had been theorized

that patients contracting PML had done so because of exposure to

multiple medications and that monotherapy with Tysabri was less risky.