http://www.fda.gov/bbs/topics/NEWS/2009/NEW01992.html
This is a psoriasis med, so I put OT, but a lot of psoriasis meds are used for RA and vice versa (never this one, that I am aware).
I have questions about some of the statements in the FDA....statement:
"Today, Genentech, the manufacturer of the psoriasis drug Raptiva
(efalizumab), announced that it has begun a voluntary, phased
withdrawal of the product from the U.S. market. The company is taking
this action because of a potential risk to patients of developing
progressive multifocal leukoencephalopathy (PML), a rare, serious,
progressive neurologic disease caused by a virus that affects the
central nervous system. By June 8, 2009, Raptiva will no longer be
available in the United States."
"The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use."
Suzanne's question: If it is so rare, why are they pulling the med? Suzanne's second question: Would they pull it if it worked? Suzanne's third question: Does this mean the chance of the rare risk outweighs the chance of any benefit?
More from the FDA statement:
"Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis."
Suzanne's fourth question: Six years? Suzanne's fifth question: Do you think many patients with moderate disease activity expected to be on med that would be voluntarily recalled for such a serious reason? Suzanne's sixth question: If it was working for a severe patient when nothing else had, and the patient was willing to take the risk, do you think they will be able to get it somehow as 'compassionate use'?
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