According to a public health advisory issued by the Food and Drug Administration, there have been reports of multifocal leukoencephalopathy (PML) - an atypical brain infection - in people being treated with the psoriasis drug Raptiva.
Raptiva, manufactured by Genentech, is a once-a-week inoculation for psoriasis patients who require whole body ‘systemic’ therapy or phototherapy. To check psoriasis, Raptiva stifles the immune system’s T-cell, thereby increasing a patient’s vulnerability to infections.
It has been found that people with severely-weakened immune system fall prey to PML, which is caused by a virus that brings about an irretrievable decline in a person’s neurological functioning, and eventual death.
In October 2008, FDA issued its severest admonition - a “black box” warning – to the Raptiva brand over the concerns about the drug’s role in increasing the risk of grave infections, PML inclusive.
According to an email by Genentech spokeswoman Tara Cooper, the manufacturer is “working diligently with the FDA to put the right plans in place that will help protect patient safety.” Cooper added that Genentech would assess “all possible approaches to address the risk of PML with Raptiva use, including a risk minimization plan.”
Meanwhile, the FDA plans to take the requisite steps for ensuring that Raptiva’s supposed risks do not overshadow its benefits, and that Raptiva-administered patients are informed about the signs and symptoms of PML!
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Sales of the drug have been
Sales of the drug have been suspended because of his disease.
Some think it may be removed from the U.S. market as well.