Two die after taking Genentech drug to treat off-label condition: NewsTarget.com

The U.S. Food and Drug Administration (FDA) announced that two lupus patients had died of a rare brain infection after being prescribed the Genentech and Biogen drug Rituxan, which was not approved to treat lupus.

In a notice posted on its website, the FDA said Rituxan was approved to treat lymphoma (cancer of the lymph nodes) and rheumatoid arthritis, but not lupus. However, doctors sometimes prescribe the drug to treat lupus through a practice known as "off-label" prescribing -- in which doctors can prescribe a medication to treat a condition it was not approved for, as long as the medicine was approved by the FDA to treat any other condition.

The two patients died after contracting a rare brain infection -- progressive multifocal leukoencephalopathy (PML) -- after they took Rituxan. The prescription instructions for Rituxan already include warning information on viral infections -- including PML -- associated with taking the drug. Cancer patients taking Rituxan have reported worsening of existing viral infections after taking the drug, or reactivation of old infections.

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Two die after taking Genentech drug to treat off-label condition

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