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#1 | ||
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Member
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"Novartis said on Wednesday it had filed FTY720, also known as fingolimod, for approval in the United States and European Union at the lower dose of 0.5 milligrams, which data showed had the best benefit-risk profile."
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#2 | |||
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Grand Magnate
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I know many good responses and stories about about RRMS. Trials were being done at Johns Hopkins with PP (My type - anyone know anything?)
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Kicker PPMS, DXed 2002 Queen of Maryland Wise Elder no matter what my count is. |
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#3 | ||
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Member
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Quote:
"Adverse effects were similar in all three trials of cladribine and fingolimod, and rates of events leading to discontinuation of a study drug were low but still at least twice as frequent with high-dose cladribine (7.9% for the 5.25-mg dose) and fingolimod (10% and 14% for the 1.25-mg dose). Herpetic infections occurred among patients receiving both cladribine and fingolimod. The rate of herpes infections among patients receiving the 1.25-mg dose of fingolimod was 5.5%; such infections were serious in three of these patients, two of whom died. Twenty cases of cutaneous herpes zoster were recorded among patients receiving cladribine, three of which were serious. Three solid tissue cancers (pancreatic, ovarian, and melanoma) occurred among patients receiving low-dose cladribine (3.5 mg per kilogram). Basal-cell carcinoma, melanoma, and breast cancer were all more common among patients receiving fingolimod than among those receiving interferon beta-1a. Macular edema was confirmed in 13 patients, 11 of whom received high-dose fingolimod (7 in the FREEDOMS trial and 4 in the TRANSFORMS trial). Of these 13 patients, 11 recovered within 1 to 6 months after discontinuation of therapy, and the condition of the other 2 patients stabilized. Transient bradycardia and first- and second-degree heart block occurred more frequently among patients receiving high-dose fingolimod than in the comparator groups. Lymphocytopenia was frequent in patients receiving both agents, more so with higher doses. Clinicians and patients will need to evaluate the risks and benefits of each of these drugs. Given the recent studies documenting the development of progressive multifocal leukoencephalopathy among patients receiving natalizumab, a monoclonal antibody against 4-integrin,8 close postmarketing surveillance will be important to detect any increase in these or other unexpected adverse effects. " |
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"Thanks for this!" says: | ewizabeth (01-20-2010) |
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#4 | |||
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In Remembrance
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Paleeeeze....they want us to take this junk and actually pay for it.
![]() ![]() ![]() Thanks for the warning, Kom.
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~Love, Sally . "The best way out is always through". Robert Frost ~If The World Didn't Suck, We Would All Fall Off~ |
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"Thanks for this!" says: | Kitty (01-20-2010) |
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#5 | |||
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Elder
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My MS center said that Fingolomoid is actually now before the FDA for approval, and it looks like this pill will pass the fire test. It has shown great promise in trials, and many have benefitted from it. Reduced lesion load, improved disability scales, and so forth.
if you start reading the label, you will make yourself crazy. they MUST list every possible, potential, and ever reported side effect anyone has ever had while being anywhere near the stuff. Heck, even the cream I use for psoraisis warns about skin cancer from continued use. scary stuff! If you were given H20 by the MD, he would have to tell you every possible cosequence of using it, including OVER hydration or increased urination from it. really intense reading if you want nightmares. I hate this stupid disease.
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RRMS 3/26/07 . Betaseron 5/18/07 . Elevated LFTs Beta DC 7/07 Copaxone 8/7/07 . . |
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#6 | |||
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Elder
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I am worried about pancreatic cancer, though...my neuro is very excited about fingolimod...I'm not so sure...
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Instant Karma's gonna get you-gonna knock you right in the head...John Lennon Last edited by Debbie D; 01-20-2010 at 08:42 PM. Reason: changed text for clarity |
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"Thanks for this!" says: | SallyC (01-21-2010) |
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#7 | |||
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Senior Member
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I just don't get it.......if approved, docs will happily dole out this chemical nightmare, but with some, ask about LDN with no dangerous side effects, and it's WHOA -- STAND BACK!!!!!! HUH??
Yeah, I hate this stupid disease too!!!!!
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_____________________________________________ .....Judy SPMS -- FIBROMYALGIA -- Ouch! and Ouch! . |
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