Northwestern Study on Rituximab Serves Up Scary Reminders

A recent study linking rituximab to a fatal brain virus in the journal Blood is a reminder that no matter the excitement caused by new drugs or therapies, we need to practice a certain degree of due diligence before undergoing them ourselves or allowing loved ones to do so.

The study, out of Northwestern University's Feinberg School of Medicine and led by Dr. Charles Bennett and his innovative RADAR Project (Research on Adverse Drug Events and Reports), linked rituximab to progressive multifocal leukoencephalitis (PML), a fatal brain disease that is often misdiagnosed as early-stage Alzheimer's.

Just a few days ago I wrote about the results of a review by the prestigious Cochran Library, which strongly advocated rituximab to patients with follicular lymphoma.

The Cochran review only confirmed for many what they already knew—that for many lymphoma patients, rituximab has been nothing short of a game-changer.

The RADAR project's findings, meanwhile, only added weight to what some have feared to be true since 2006—that for some people, rituximab might be life-threatening.

However, it's too early to say how rituximab and PML might be linked, or which potential patients might be at risk.

Lymphoma patients aren't the only ones who have benefitted from rituximab; people with rheumatoid arthritis as well as (off-label) those with multiple sclerosis, lupus and anemia have too. What's frightening is that rituximab is now the third monoclonal antibody to be linked with PML; the first was efalizumab (Raptiva), the next was natalizumab (Tysabri) . Both drugs were removed from the US market; Tysabri eventually returned, with new warnings.

As Dr. Bennett told Science Daily (my primary source for this blog entry), "People have been lulled into a false sense of security that this drug is harmless and that it only does good things. No drug is perfect."

Hallelujah. And thank goodness for the likes of the RADAR project (more on them later).

Bennett further recommended that all patients taking rituximab should be closely monitored for neurological symptoms that might indicate PML, including 'forgetfulness, disorientation or mood changes'.

--Science Daily's report on rituximab and PML
--UPI piece announcing Raptiva's removal from the US market
--Biogen letter announcing changes to Tysabri's safety and confirming its return to the US market.
--MedScape piece about projects like RADAR that try to bring adverse drug events (ADE) to publication sooner than they would otherwise be.

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