The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

The FDA has confirmed three reports of death from progressive multifocal leukoencephalopathy (PML) associated with the Psoriasis drug, Raptiva. A fourth case is being looked at as well.

PML is a rare and often-fatal brain infection, where there is inflammation of the brain’s white matter. Patients with a severely compromised immune system are at risk of suffering from an irreversible brain function and possibly death. No treatment exists for PML.

Psoriasis is a chronic and painful skin disorder characterized by inflamed, red, scaly lesions, caused when affected skin cells reproduce faster than normal. Certain forms of psoriasis may be fatal.

Raptiva’s product labeling was revised in October 2008 to include a boxed warning about the risks of life-threatening infections associated with the drug, including PML.

Genentech, the manufacturer, was directed by the agency at that time to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide intended to educate patients about the drug’s associated risks.

The agency advises health care professionals to carefully monitor patients taking Raptiva for any sign of neurologic disease.

In September 2008, the drug Rituxan, also manufactured by Genentech, revised its labeling after a woman who was treated with it died from PML, according to the U.S. Food and Drug Administration (FDA).

Comments are closed.

Of Interest