PML Side Effect Concerns Moving Beyond MS to RA (RHHBY, BIIB)

October 24, 2009 · Filed Under fda, multiple sclerosis, rheumatoid arthritis 

PML, or progressive multifocal leukoencephalopathy, is moving beyong TYSABRI as a side effect in the world of drugs and pharmaceuticals.  Yesterday the FDA posted a ‘Dear Doctor letter’ from Genentech, now part of Roche (OTC: RHHBY).  Unfortunately, this involves Biogen Idec, Inc. (NASDAQ: BIIB) as well.  The two companies notified healthcare professionals about a third case of PML, the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a TNF antagonist.

The companies noted that information to date suggests that patients with RA who receive Rituxan have an increased risk of PML and that doctors should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations.

You can read the full letter and explanations here.  Unfortunately, PML risks are likely to come more front and center in the coming weeks and months.

It is worth noting that this is not the first of the potentially fatal side effects of Rituxan.  There have been prior warnings of brain disorders and other warnings including cardiac arrest, reactivation of Hepatitis B, kidney failure, and more.  And PML is already a noted risk in Rituxan.

It JON C. OGG

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