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MARYCAIN
12-26-2006, 01:55 PM
I posted this in Medications section but not everyone goes there - wanted to make sure everyone was aware of it.

The FDA has issued a public health advisory warning about the use of Rituxan after two lupus patients who received Rituxan died of a brain infection called progressive multifocal leukoencephalopathy, or PML. The FDA is urging all doctors to discuss the risk of PML with Rituxan patients. There is no known treatment for PML and it is usually fatal if contracted. Warning symptoms include confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems. Of course, most lupus patients have those anyway as a result of the disease, but any one taking Rituxan should be especially alert. Biogen and Genentech have sent warning letters to doctors - just wanted to make sure all you guys were aware of it too.

hooversmom
12-27-2006, 06:38 PM
This sounds identical to the warnings for Tysarbi for MS patients. (It is a monoclomal antibody too)

Saysusie
12-29-2006, 12:13 PM
Excellent Post, as usual Marycain!!

Thank You So Much
Saysusie

kkelly
12-29-2006, 07:20 PM
I wonder if the same warnings hold for Epratuzumab? Its also a monoclonal antibody for CD22 I believe. Its in clinical trial for SLE right now. Its also a NHL drug first and foremost. Any thoughts anyone?
Karen
I am panicking thinking that rituxan will be shelved for lupus as nothing else has really helped at all. Rituxan certainly wasn't a magic bullet though.

MARYCAIN
12-29-2006, 07:54 PM
I think all the monoclonal antibody drugs would carry the same type of potential risks and side effects. Tysarbi was actually pulled from the market for a while because of an association with PML, then re-approved by the FDA under fairly stringent controls, because there are so few drugs available to treat MS. But I think there were only 2 or 3 cases of PML associated with Tysarbi, and there have already been at least 25 known cases of PML in Rituxan patients (although only two of them were lupus patients - the others were being treated for NHL). And since epratuzumab is just in the clinical trial stage and hasn't been FDA-approved yet, the PML issues will probably have to be studied a lot more before it's approved. Epratuzumab has already run into one problem with the FDA that caused all the clinical trials to be put on hold - that suspension was just lifted last month. So I think it will probably be a long time before we see any of these drugs get FDA approval specifically for lupus. And because of the potential malpractice issues, some of the rheumatologists who were giving Rituxan "off-label" for lupus will probably stop. Even though it's perfectly legal to prescribe most drugs off-label and doctors do it all the time, it can leave them wide-open to a malpractice lawsuit if something goes wrong. From the legal standpoint you can't blame the doctors for being cautious, but it definitely makes it harder on the patients.