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Rituxan linked to fatal viral brain disease

Rituxan, a cancer medication manufactured by Genentech and BioGen Idec, has been linked to a fatal viral brain infection called progressive multifocal leukoencephalopathy

Rituxan, a cancer medication manufactured by Genentech and BioGen Idec, has been linked to a fatal brain infection called progressive multifocal leukoencephalopathy (PML).

At least two patients undergoing Rituxan therapy have died of PML, which causes progressive inflammation of the brain. Sufferers present with neurological symptoms, such as confusion, dizziness or loss of balance, difficulty talking or walking and vision problems. PML gets worse over time, and is usually fatal. There is no treatment or cure for the disease.

The FDA said that the two patients developed PML after they took Rituxan as a treatment for systemic lupus erythematosus (SLE). Rituxan is not approved to treat SLE and has only been approved to treat non-Hodgkin's lymphoma (NHL) and rheumatoid arthritis (RA) when other treatments have failed.

The FDA added that despite the fact that Rituxan is not approved to treat SLE, it estimates that as many as 10,000 SLE patients have received the drug.

Once a drug is approved by the FDA, US-based doctors may prescribe it in any way they choose. However, pharmaceutical companies are not permitted to advertise other off-label uses. If a doctor asks for information on off-label treatments, companies can provide it.

Many prescription drugs are prescribed in this way, as is seen with the current debate in the US and the UK over the prescribing of Avastin (bevacizumab), which is normally prescribed to treat bowel cancer, for age-related macular degeneration (AMD).

The drug approved to treat AMD is called Lucentis (ranibizumab) and costs much more than Avastin. Thus, doctors have been saving money by injecting the cheaper drug into the eyes of patients with AMD. Lucentis and Avastin are similar drugs, however. In the case of Rituxan, no studies have been conducted to demonstrate safety for use in SLE.

Rituxan suppresses the immune system, so doctors have assumed that Lupus, which is an autoimmune disease, could be treated with it. However, the use of Rituxan in SLE could be higly dangerous because of the concomitant risks associated with immune suppression, such as PML.

In February 2006, the labelling of Rituxan was updated to include information about the risks of patients contracting several viral infections, including PML. The FDA also cautioned doctors considering treating a patient with Rituxan for any condition to inform the patient of the risk of developing PML.

Q2 FY07 sales of Rituxan, which is Genentech's best-selling drug, grew 11 per cent to rest at USD 582m.

15th August 2007

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